Generation of self-organized sensory ganglion organoids and retinal ganglion cells from fibroblasts – Science Advances

INTRODUCTION

A ganglion is a cluster or group of nerve cells found in the peripheral nervous system (PNS) or central nervous system (CNS). They often interconnect with each other and with other structures in the PNS and CNS to form a complex nervous network. There are three groups of ganglia in the PNS, which are the dorsal root ganglia (DRG), cranial nerve ganglia, and autonomic ganglia, and two types of ganglia in the CNS, which are the basal ganglia in the brain and retinal ganglion in the retina. Unlike other ganglia, which are essentially cell clusters, retinal ganglia consist of a layer/sheet of dispersive retinal ganglion cells (RGCs). Diverse types of neurons in the somatosensory ganglia such as DRG are specialized for different sensory modalities such as proprioception, mechanoreception, nociception (i.e., pain perception), thermoception, and pruriception (i.e., itch perception) (1, 2). Similarly, there are numerous subtypes of RGCs that are specialized for transmitting from the retina different visual information (e.g., color, contrast, and motion direction) to the central visual system in the brain (3). In the human, a variety of pain, itch, neurological, and degenerative disorders affect sensory ganglia (SGs) and RGCs. Mutations in the FXN (frataxin) and IKBKAP genes, for example, result in debilitating Friedreichs ataxia and familial dysautonomia, respectively (4, 5). Dominant gain-of-function mutations in the sodium channel Nav1.7 gene SCN9A, which is expressed in sensory neurons, are linked to two severe pain syndromesinherited erythromelalgia and paroxysmal extreme pain disorder, while its recessive loss-of-function mutations cause dangerous congenital insensitivity to pain (6). Recently, peripheral SG dysfunction has also been linked to tactile sensitivity and other behavioral deficits associated with the autism spectrum disorders (7). Both genetic and environmental risk factors contribute to glaucoma, which is a leading cause of blindness worldwide and characterized by progressive degeneration of RGCs and the optic nerve (8).

Despite the difference in morphology and embryonic origin, somatosensory and retinal ganglia share extensive overlap of gene expression and we proposed more than two decades back that both might also share genetic regulatory hierarchies (9, 10). This assumption has largely turned out to be the case. During embryogenesis, somatosensory ganglion neurons arise from the multipotent neural crest (NC) cells through a process of cell migration and coalescence (1). RGCs are also derived from multipotent retinal progenitor cells and destined to the ganglion cell layer by migration. It has been shown that the neurogenic bHLH transcription factors (TFs) Ngn1 and/or Ngn2 are involved in the determination of peripheral sensory neurons (11), and that the homeodomain TFs Isl1 and Brn3a or Brn3b are required for the specification and differentiation of different subtypes of neurons in the somatosensory and retinal ganglia (1217). Moreover, there is substantial functional redundancy between Ngn1 and Ngn2 as well as between Brn3a and Brn3b in the development of sensory neurons and RGCs (11, 18, 19).

Somatic cell reprogramming by defined TFs into sensory neurons provides a powerful strategy for studying mechanisms of SG development and sensory disease pathogenesis and for generating cells for patient-specific cell replacement therapy, drug screening, and in vitro disease modeling. It has been shown recently that nociceptor and other subtypes of sensory neurons can be directly induced from murine and human fibroblasts by Brn3a and Ngn1 or Ngn2 or by a combination of five TFs including Ascl1, Ngn1, Isl2, Myt1l, and Klf7 (20, 21). The induced sensory neurons express characteristic marker proteins and are electrically active and selectively responsive to various agonists known to activate pain- and itch-sensing neurons (20, 21). However, networked SG did not appear to be consistently generated in these cases, and it is unclear whether RGCs were induced by these combinations of TFs.

Given the advantages of organoids in studying developmental mechanisms and modeling and treating relevant diseases, we sought to generate ganglion organoids and RGCs from mouse and human fibroblasts using TFs controlling in vivo development of sensory and retinal ganglia. The extensive molecular homology between SG neurons and RGCs creates a dilemma as to how to distinguish these two types of neurons. In the past, several RGC markers including Brn3a, Brn3b, Isl1, Thy1.2, Sncg, Math5, Rbpms, and RPF-1 were used to identify RGCs induced from embryonic stem cells (ESCs), induced pluripotent stem cells (iPSCs), and somatic cells (2225). However, this is a questionable practice because although these markers are sufficient to identify RGCs within the retina, they are inadequate as specific markers for identifying induced RGCs (iRGCs), given their expression in SG and other CNS regions as well (10, 15). We thus carefully screened for RGC-specific markers by comparing expression patterns of numerous known markers in the retina and DRG. This analysis revealed Pax6 expression in RGCs but not in DRG and that RGCs can be identified as Pax6+Brn3a+ or Pax6+Brn3b+ double-positive cells. Equipped with this knowledge, we set to generate induced SG (iSG) organoids and iRGCs from fibroblasts by testing the combination of Ascl1, the pioneer neurogenic TF for somatic cell reprogramming of neurons (26), with a variety of SG and retinal TFs. This screen identified a triple-factor combination ABI (Ascl1-Brn3a/3b-Isl1) as the most efficient way to induce self-organized and networked iSG and iRGCs from fibroblasts.

Previous studies by our group and others have demonstrated that SGs and RGCs share similar transcriptional regulatory mechanism for their development, for instance, both Brn3 TFs (Brn3a and Brn3b) and Isl1 are involved in the specification and differentiation of DRG neurons and RGCs (1214, 16). More recently, Ascl1 has been shown to play a pioneering role in induced neuron (iN) reprogramming from somatic cells (26). As a first step to generate iSG and iRGCs directly from somatic cells, we sought to induce SG neurons and RGCs from mouse embryonic fibroblasts (MEFs) by testing the combination of Ascl1 with each of 22 SGs and retinal TFs (Brn3b, Isl1, Math5, Ebf1, Pax6, Tfap2a, Nr4a2, Nrl, Crx, Ptf1a, Neurod1, Lhx2, Ngn1, Ngn2, Chx10, Sox2, Rx, Meis1, Foxn4, Otx2, Sox9, and Six3). When MEFs were infected with doxycycline (Dox)inducible Ascl1 and Brn3b (AB) or Isl1 (AI) lentiviruses and cultured in the neural differentiation medium containing Dox, they started to change morphology by day 7 and form visible neuronal clusters by day 14 (Fig. 1, C and D). This phenomenon did not occur when Ascl1 acted alone or was combined with each of the rest of 20 TFs (Fig. 1B). Neither did this happen when MEFs were infected with both Brn3b and Isl1 viruses or with only control green fluorescent protein (GFP) viruses (Fig. 1, A and E). When we combined Ascl1 with both Brn3b and Isl1 (ABI), they again induced morphological changes of MEFs but more importantly induced conspicuously more neuronal clusters than either the AB or AI double-factor combinations (Fig. 1, C, D, F, and N, and fig. S1, A and B), suggesting a synergistic effect between Brn3b and Isl1 in reprogramming MEFs into neuronal clusters.

(A to I) Morphological changes of MEFs infected with the indicated lentiviruses (A, Ascl1; B, Brn3b; I, Isl1) and cultured for 14 days. Networked iSGs were induced by combinations of Ascl1 with Brn3b (AB), Isl1 (AI), or both Brn3b and Isl1 (ABI), with the ABI triple-factor combination as the most efficient. Arrows point to the thick fasciculated nerve fibers interconnecting iSG. Scale bars, 160 m (A to F) and 80 m (G to I). (J to M) Scattered iNs and clustered iSG induced by AI, ABI, A, or BAM (Brn2 + Ascl1 + Myt1l) were immunolabeled for Tuj1 and counterstained with nuclear 4,6-diamidino-2-phenylindole (DAPI). Note the morphological differences of Tuj1-immunoreactive neurons between conditions. Scale bars, 40 m. (N) Quantification of iSG induced by single and combinations of TFs. MEFs (6 104) were seeded into each well of 12-well plates and infected with lentiviruses expressing the indicated TFs or GFP, and iSGs in each well were then counted at day 14 following virus infection. Data are means SD (n = 3). Asterisks indicate significance in one-way analysis of variance test: *P < 0.0001. (O) Snapshots of a time-lapse video showing how individual neurons induced by ABI self-organized into an iSG. The arrow, arrowhead, and asterisk indicate the positions of three individual iNs at different time points. Scale bar, 62.5 m. (P) Schematic indicating the outcome (iNs or iSG) of MEFs induced by BAM, AI, AB, or ABI.

The neuronal clusters induced by either double- or triple-factor combinations (AB, AI, and ABI) appeared to be interconnected by thick fasciculated nerve fibers and resemble SG plexus in morphology (Fig. 1, G to I) and thus were designated as iSG organoids. The iSG neurons and associated nerve fibers were highly immunoreactive for the neuronal marker Tuj1 (Fig. 1, J and K, and fig. S2, D to I). Tuj1 immunolabeling also showed that AI- and ABI-induced neurons mostly formed iSG, and only a small number of them were scattered outside the iSG (Fig. 1, J, K, and P). By contrast, Tuj1 immunoreactivity showed that Ascl1 alone induced neurons mostly with an immature morphology and that the BAM (Brn2, Ascl1, and Mytl1) combination induced mature neurons that were scattered instead of clustered (Fig. 1, L, M, and P, and fig. S2, A to C), consistent with previous reports (27). Therefore, we identified the AB, AI, and ABI combinations of TFs capable of inducing MEFs into iSG, with the ABI triple-factor combination as the most efficient.

To investigate how ABI-reprogrammed neurons are organized into iSG, we used long-term time-lapse microscopy to track them over time in culture. For this purpose, MEFs were prepared from the CAG-GFP transgenic mouse embryos (28) and induced by ABI for 10 days before time-lapse recording. Compared to MEFs, reprogrammed individual neurons appeared to be rounder and neurite-bearing and displayed much higher contrast and brighter GFP fluorescence (Fig. 1O and movies S1 and S2). Over a period of tens of hours, they first formed smaller cellular clusters via migration, which then coalesced into bigger and bigger clusters that resembled SG. We did not observe this self-organization phenomenon for neurons induced by Ascl1 (movies S3 and S4).

The induction of iSG by TFs from MEFs could be through direct cell conversion or might be mediated through an intermediate proliferative progenitor. To distinguish these possibilities, we pulse-labeled cells with 5-ethynyl-2-deoxyuridine (EdU) for 24 hours at day 14 of reprogramming with AI or ABI and found that almost no Tuj1-positive cells were labeled by EdU, whereas approximately 15% of Tuj1-negative cells (e.g., MEFs) were labeled (fig. S2, G to J and N to P). We then reprogrammed MEFs with ABI in the presence of EdU for 13 days starting from day 1 of reprogramming. In this case, only 6.1% of Tuj1-positive cells were labeled by EdU, whereas 73.1% of Tuj1-negative cells were labeled (fig. S2, J to M), suggesting that iSGs are most likely induced by direct cell transdifferentiation without undergoing a proliferative intermediate state. In agreement with these results, as determined by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assays, we detected no increase of expression levels of the neural progenitor marker genes Nestin and Olig2 over the entire time course (from day 1 to day 12) of ABI reprogramming (fig. S2Q). Similarly, the expression of pluripotent factor genes Oct4, Klf4, and Nanog was not induced during the time course of ABI reprogramming (fig. S2R). Furthermore, immunostaining showed that from day 1 to day 12 of ABI reprogramming, no protein expression was seen for the neural progenitor marker Nestin, pluripotent progenitor markers Nanog and Oct4, or Sox2, a marker for both neural and pluripotent progenitor cells (fig. S2, S and T). Thus, iSGs are most likely induced by direct cell transdifferentiation without undergoing an intermediate state of neural or pluripotent progenitors.

Given the demonstrated functional redundancy and similar DNA binding and transcriptional properties between Brn3a and Brn3b (10, 18, 19), we investigated whether these two factors are interchangeable in somatic cell reprogramming. We tested whether Brn3a was able to replace Brn3b in reprogramming MEFs into iSG and found that this indeed was the case (Fig. 1N and fig. S3, A to I).

By immunofluorescent staining and qRT-PCR assays, we examined a variety of molecular neuronal markers, both general and cell type specific, to characterize the iSG reprogrammed from MEFs by ABI (Ascl1 + Brn3b + Isl1 or Ascl1 + Brn3a + Isl1). We found that they were highly immunoreactive for Tuj1 and Map2 (Fig. 2, A and O), two general neuronal hallmarks. They also expressed synapsin and Vamp (synaptobrevin) (Fig. 2, B and C), suggesting that the networked iSG neurons were capable of forming synapses and releasing synaptic vesicles. In the normal SG, the heavy neurofilament NF200 and intermediate neurofilament peripherin are expressed in the A-fiber and C-fiber neurons, respectively, and both were seen to be expressed in the iSG (Fig. 2, D, E, and P). Many neurons in the iSG were also immunoreactive for the vesicular glutamate transporters 1 and 2 (vGLUT1 and vGLUT2) (Fig. 2, F and G), consistent with the fact that peripheral sensory neurons are mostly excitatory glutamatergic neurons. As determined by qRT-PCR, these immunolabeling results were confirmed by the marked up-regulation of expression of Tuj1, Map2, NF200, vGlut1, vGlut2, and vGlut3 genes in the ABI-induced iSG compared to MEFs infected by GFP lentiviruses (Fig. 2W).

(A to P) iSGs induced by Ascl1, Brn3b, and Isl1 (A to N) or Ascl1, Brn3a, and Isl1 (O and P) were double-immunostained with the indicated antibodies and counterstained with nuclear DAPI. They were immunoreactive for Tuj1, Map2, synapsin, Vamp, NF200, peripherin, vGLUT1, vGLUT2, TrkA, TrkB, TrkC, c-Ret, TH, p75NTR, and Brn3a. Scale bars, 80 m (A) and 40 m (B to P). (Q to V) Sections from iSG induced by Ascl1, Brn3b, and Isl1 were immunostained with the indicated antibodies and counterstained with nuclear DAPI. Scale bars, 12.7 m. (W) qRT-PCR analysis showing that in MEFs infected with ABI (Ascl1 + Brn3b + Isl1) viruses, compared to those infected with GFP viruses, there was a significant increase in expression of the indicated genes, which represent general and subtype-specific sensory neuron markers. Data are means SD (n = 3 or 4). Asterisks indicate significance in unpaired two-tailed Students t test: *P < 0.05, **P < 0.001, ***P < 0.0001. (X) qRT-PCR analysis showing that in MEFs infected with ABI viruses, compared to those infected with GFP viruses, there was a significant increase in expression of the indicated genes, which represent nociception pathway genes of sensory neurons. Data are means SD (n = 3 or 4). Asterisks indicate significance in unpaired two-tailed Students t test: *P < 0.05, **P < 0.005, ***P < 0.0005. (Y) Quantification of Tuj1-positive neurons that express each of the three Trk receptors (TrkA, TrkB, or TrkC) individually or combined (TrkABC) in MEFs infected with the ABI viruses. Data are means SD (n = 3).

In the DRG, neurotrophin receptor expression marks subtypes of sensory neurons. For instance, TrkA is expressed by cutaneous nociceptive and thermoceptive neurons, TrkB by a subset of cutaneous mechanoreceptive neurons, and TrkC by proprioceptive neurons (1). In the iSG reprogrammed by ABI, qRT-PCR assays revealed that there was a significant up-regulation of TrkA, TrkB, and TrkC gene expression (Fig. 2W). Moreover, immunolabeling confirmed the presence of TrkA, TrkB, and TrkC proteins in both somas and nerve fibers of the induced ganglion neurons (Fig. 2, H to J). Each of the Trk receptors was found in approximately 30% of the iNs, and 87% of the iNs were labeled by costaining for all three Trk receptors (Fig. 2Y), suggesting that each Trk receptor was expressed in a distinct subpopulation of induced ganglion neurons. c-Ret and TH are expressed in subpopulations of nonpeptidergic nociceptors and C-low threshold mechanoreceptors, respectively (1, 2). Correspondingly, we observed expression of both proteins in the iSG and associated nerve fibers (Fig. 2, K and L). In addition, pan-sensory neuron markers Brn3a (for iSG induced by Ascl1 + Brn3b + Isl1) and the nerve growth factor (NGF) receptor p75NTR were also found in iSG neurons (Fig. 2, M and N). qRT-PCR validated the up-regulation of Brn3a and p75NTR expression in the iSG and additionally revealed up-regulation of CGRP, a marker for a subpopulation of peptidergic nociceptive neurons (Fig. 2W).

The TrkA-positive nociceptive neurons in the iSG were further characterized by qRT-PCR analysis. In the iSG, we found significantly up-regulated expression of receptor ion channel genes Trpv1/2/3 and Trpa1, which detect heat and cold, respectively (Fig. 2X) (29). There was also expression of P2X3, Bdkrb1, and Accn1/2, which are receptor genes responsible for damage sensing (Fig. 2X) (29). In addition, induced expression was observed for other pain perception pathway genes including sodium channel gene Scn11a, potassium channel gene Kcnq2, calcium channel genes Cacna1a and Cacna2d1, and neurotransmitter receptor genes Gria1 and Nk1r (Fig. 2X) (29). To further investigate whether distinct types of sensory neurons were aggregated together within the same iSG, we carried out immunostaining analyses of cryosections of ABI-induced iSG. Besides colabeling between Tuj1 and Brn3a in the same iSG, we found that peripherin+ and HuC/D+ neurons, P2X3+ and vGLUT2+ neurons, and TrkA+ and TrkB+ neurons coexisted in the same iSG (Fig. 2, Q to T). Moreover, we detected coexpression of three markers, such as TrkA, P2X3 and NF200, and TrkA, peripherin, and HuC/D, in the same iSG (Fig. 2, U and V), suggesting that individual iSGs are likely aggregated from distinct sensory neuron types.

Over the time course of ABI reprogramming, qRT-PCR assays showed that the expression of general neuronal marker genes Tuj1 and Map2 was progressively induced starting from day 3, whereas other sensory neuronal marker genes including Trpv2, TrkC, and Brn3a were not induced until day 6 or 9 (fig. S1, C to E). Consistent with this, Brn3a-immunoreactive cells did not emerge until day 6 with a mostly scattered pattern, but by day 9 or 12, they mostly coalesced into iSG (fig. S1G). Therefore, as expected, sensory neuronal markers were induced slightly later than general neuronal markers during ABI reprogramming. Concomitant with neuronal induction, the fibroblast marker genes Col1a1 and Twist2 were gradually down-regulated starting from day 3 (fig. S1F).

Immunostaining of iSG induced by AI or AB suggested that they also contained neurons that expressed typical sensory neuronal markers Tuj1, Map2, Dcx (doublecortin), synapsin, NF200, peripherin, vGLUT1, TrkA, TH, HuC/D, and Brn3a (fig. S3, J to S). Together, these data indicate that certain combinations of TFs (ABI, AI, and AB) are capable of reprogramming MEFs into iSG that contain proprioceptive, mechanoreceptive, nociceptive, and thermoceptive sensory neurons.

To assess the electrophysiological properties of neurons within and outside the iSG reprogrammed from MEFs by ABI or AI, we performed whole-cell patch-clamp recordings of cells with neuronal morphology (Fig. 3A). Following 9 days of induction, the recorded neurons (two of two) generated potassium currents and small sodium currents but no action potentials, suggesting that they were functionally immature. At 2 weeks, the great majority of neurons (34 of 37) had typical sodium and potassium currents and exhibited action potential responses (Fig. 3, B to F). Among them, most (70.3%) are multispiking neurons, and the rest (21.6%) are single-spiking (Fig. 3, B, C, E, and K), similar to those reprogrammed from human fibroblasts by Brn3a and Ngn1 or Ngn2 (21). The inward sodium current could be specifically blocked by tetrodotoxin (TTX) and recovered by its removal (Fig. 3, H to J). Moreover, consistent with the synapsin immunoreactivity (Fig. 2B and fig. S3L), some neurons (2 of 37) exhibited spontaneous postsynaptic currents (Fig. 3G), suggesting the formation of functional synapses between iNs. Therefore, the iSG neurons induced by ABI or AI display membrane and physiological properties of mature neurons.

(A) Micrograph showing a typical iSG neuron chosen for patch-clamp recording. (B to D) Current-clamp recordings revealed multiple action potential responses (multiple-spiking) of a differentiated iSG neuron under current injection (B and C). Voltage-clamp recordings of the same neuron indicated fast activated and inactivated inward sodium currents as well as outward potassium currents (D). (E and F) Current injection revealed a single action potential response (single-spiking) of an iSG neuron (E). Voltage-clamp recordings of the same neuron indicated fast activated and inactivated inward sodium currents as well as outward potassium currents (F). (G) Spontaneous postsynaptic currents recorded from a differentiated iSG neuron. (H to J) The sodium currents of an iSG neuron were completely blocked by TTX and were partially restored by its washout. (K) Observed ratios of iSG neurons that are multiple-spiking and single-spiking, or display no action potential (AP). (L to N) iSG induced by ABI and corresponding fluorescent signals after incubation with Fluo-8 AM. Scale bars, 20 m. (O to Q) Calcium changes indicated by fluorescent intensity in normal Ringers solution (O), 10 M capsaicin (P), and 100 mM KCl (Q). Scale bars, 20 m. (R) Representative calcium responses to 100 M menthol and 100 mM KCl. Calcium responses were calculated as the change in fluorescence (F) over the initial baseline fluorescence (F0). (S) Representative calcium responses to 10 M capsaicin and 100 mM KCl. (T and U) Scatter dot plots showing the positive responses of individual cells to menthol, capsaicin, or KCl. Data are means SEM (n = 19 to 44).

The nociceptive sensory neurons express ion channels Trpv1, Trpm8, and Trpa1, which respond to heat, cold, and noxious chemicals, respectively (29). By calcium imaging, we used specific agonists capsaicin (10 M) and menthol (100 M) for Trpv1 and Trpm8 to confirm the functional expression of these two channels in iSG neurons (20, 21). KCl (100 mM) was transiently perfused to monitor the functional viability of the cells at the beginning and end of recording. Only cells that showed responses to KCl were chosen for analysis. Nearly all the iSG clusters induced by ABI showed green fluorescence following incubation with the calcium indicator Fluo-8 AM (Fig. 3, L to N). We found that among all the recorded cells, 56.8% of them (25 of 44) responded to capsaicin and 70.4% (19 of 27) to menthol (Fig. 3, O to U), suggesting that a large number of iSG neurons express ion channels characteristic of nociceptive sensory neurons.

We investigated the ability of iSG neurons to survive and integrate in the DRG by microinjecting dissociated iSG neurons reprogrammed from CAG-GFP mouse embryos (28), into adult rat DRG explants (fig. S4A). Following 2 weeks of culture of the transplanted explants, we found that the GFP+ iSG neurons survived, spread, and integrated in the DRG and were immunoreactive for the pan-sensory neuron marker HuC/D (fig. S4B). Moreover, a large fraction of them were immunoreactive for TrkA, while a small portion expressed TrkB or TrkC (fig. S4, C to E), indicating that iSG neurons maintain subtype specificity in the DRG.

Consistent with their sensory neuron identity, after a week in culture, iSG neurons reprogrammed from Tau-GFP mouse embryos (30) spontaneously aggregated with rhodamine-labeled sensory neurons dissociated from E13.5 mouse DRGs to form DRG-like organoids interconnected by nerve fibers (fig. S4, N to Q). In contrast, when GFP+ iSG neurons were cocultured with P0 mouse skin cells, they did not co-aggregate with skin cells; instead, they projected to and innervated vimentin-immunoreactive epidermal cells with multiple terminal nerve endings (fig. S4, J to M), in agreement with the fact that DRG neurons normally innervate their peripheral targets in the epidermis.

Previous studies have demonstrated that peripheral SG neurons and RGCs share many common molecular hallmarks, making it difficult to distinguish these two types of sensory neurons in cell culture. During the past decade in stem cell research, a number of supposedly specific molecular markers have been used to identify differentiated or induced SG neurons and RGCs (2225); unfortunately, however, no efforts have been made to confirm the specificity of these markers, casting doubt on some of the previous conclusions. Because Brn3a, Brn3b, and Isl1 are TFs crucial for retinal cell development, in particular, RGC development (13, 14, 16), there is a possibility that they may also be able to reprogram MEFs into RGCs. We thus set out to identify molecular markers that can definitively distinguish RGCs from peripheral sensory neurons. We postulated that such unique identifiers could be single-molecule markers or a combination of multiple-molecule markers that must be present only in RGCs within the retina but not in peripheral sensory neurons or any other tissues.

In the mammalian retina, our early studies have identified Brn3a and Brn3b as the gold standard markers for RGCs, but meanwhile revealed their expression in peripheral SG and other CNS areas (10, 15). In the mouse, immunolabeling of retinal and DRG sections confirmed the specificity of Brn3a and Brn3b in RGCs within the retina as well as their widespread expression in DRG neurons (fig. S5A), indicating that Brn3a and Brn3b alone cannot distinguish RGCs from DRG neurons outside the retina. Similarly, many other commonly used RGC markers including Thy1.2, RPF-1, Rbpms, HuC/D, Six6, Ebf, Isl1, Zeb2, Lmo4, Ldb1, and Sncg all displayed expression in the DRG (fig. S5A). Expressed in both RGCs and DRGs were also a number of sensory neuron markers including CGRP, peripherin, vGLUT2, vGLUT3, GABA, TrkA, TrkB, TrkC, and P2X3 (fig. S5A). Pax6 appeared to be the only exception among all the tested markers, which is expressed in RGCs and inner nuclear layer within the retina but absent from DRG (fig. S5A). Given the expression of Brn3a, Brn3b, Thy1.2, RPF-1, and Rbpms only in RGCs within the retina, a combination of Pax6 with any of these proteins could serve as a potential unique identifier for RGCs.

The uniqueness of double-positive markers was tested by immunolabeling sections of other CNS areas. Double-immunostaining showed that neuronal cells immunoreactive for both Pax6 and RPF-1, Thy1.2, Rbpms, HuC/D, or Tuj1, albeit absent from the DRG, were present not only in the retina but also in the spinal cord (Fig. 4A), precluding their use as specific RGC markers. The Isl1+Pax6+ double-positive cells were absent from the DRG and spinal cord but present within both the ganglion cell layer and inner nuclear layer in the retina (Fig. 4A), precluding also this combination as a specific RGC identifier. By contrast, Brn3a+Pax6+ and Brn3b+Pax6+ double-positive cells were exclusively RGCs in the retina and were not found in the DRG or spinal cord (Fig. 4A). Given the detection of Brn3a/Brn3b expression in the midbrain and cerebellum (10, 15), we investigated whether there were Brn3a+Pax6+ and Brn3b+Pax6+ double-positive cells in these two brain regions and found none at stages E13.5, P4, and P21 (Fig. 4A). Thus, these results together demonstrate that a combination of Pax6 and Brn3a or Brn3b double markers can serve as specific identifiers for RGCs.

(A) Cryosections from the indicated regions and stages of mice were stained by double immunofluorescence with the indicated antibodies and counterstained with nuclear DAPI. Arrows point to representative double-positive cells. GCL, ganglion cell layer; INBL, inner neuroblastic layer; INL, inner nuclear layer; IPL, inner plexiform layer; ONBL, outer neuroblastic layer; ONL, outer nuclear layer; OPL, outer plexiform layer. Scale bars, 40 m. (B to E) MEFs were infected with the ABI lentiviruses, cultured for 14 days, and double-immunostained with the indicated antibodies and counterstained with nuclear DAPI. Arrowheads in (D) indicate colocalized cells in the outlined region located outside the iSG. Scale bars, 40 m (B and C) and 20 m (D and E). (F to I) MEFs infected with the ABI lentiviruses and cultured for 14 days were dissociated and double-immunostained with anti-Brn3a and anti-Pax6 antibodies and counterstained with nuclear DAPI. Arrows indicate colocalized cells. Scale bars, 20 m. (J) qRT-PCR analysis of expression levels of the indicated genes (ex, exogenous; en, endogenous) in MEFs infected with ABI or GFP viruses (means SD, n = 3 or 4). *P < 0.05, **P < 0.001, ***P < 0.0001. (K and L) Quantification of DAPI- or Tuj1-positive cells that express Brn3a or Pax6 in MEFs infected with the ABI viruses (means SD, n = 4). (M) Quantification of Brn3a+Pax6+ iRGCs induced by ABI (means SD, n = 4).

We used the single-cell RNA sequencing (scRNA-seq) technology to further confirm the specificity of Brn3a+Pax6+ and Brn3b+Pax6+ double-positive markers. A Brn3b-GFP knockin mouse line was generated, and RGCs were enriched and sequenced by scRNA-seq. In addition, we isolated adult mouse DRG cells, which were then similarly sequenced. Clustering and expression analyses of the sequenced RGCs revealed that most of them expressed Pax6, Brn3a, or Brn3b and both Pax6 and Brn3a or Brn3b; in particular, the great majority of RGCs were positive for both Pax6 and Brn3a (fig. S5B). By contrast, there was a complete absence of DRG cells expressing both Pax6 and Brn3a or Brn3b, although Brn3a and Brn3b were present in most DRG cells (fig. S5B), consistent with the idea that a combination of Pax6 and Brn3a or Brn3b double markers can be used to distinguish RGCs from DRG cells.

To assess whether ABI and AI are able to induce iRGCs in addition to iSG, we immunostained ABI-reprogrammed MEF cells with antibodies against Tuj1, Brn3a, and/or Pax6. Double-labeling between Tuj1 and Brn3a or Pax6 showed that Brn3a-expressing cells were concentrated in the iSG, whereas the great majority of Pax6-expressing cells were distributed outside of the iSG and only few of them were seen in the iSG (Fig. 4, B and C). Moreover, all Pax6-positive cells coexpressed Brn3a and most of them displayed relatively weak Brn3a expression (Fig. 4, D and F to I), indicating that iRGCs were reprogrammed from MEFs by ABI. Similar to the distribution of endogenous RGCs that are spread throughout the RGC layer, the Brn3a+Pax6+ iRGCs were scattered and did not organize into clustered mini-ganglia (Fig. 4, C and D), unlike the induced peripheral SG neurons. Quantification of immunoreactive cells indicated that approximately 21.1% of all cells were induced by ABI into Brn3a+ neurons, whereas only about 2.6% of them were reprogrammed into Pax6+ cells (Fig. 4K). Furthermore, there were 93.1% of Tuj1+ cells coexpressing Brn3a, 10.5% of Tuj1+ cells coexpressing Pax6, and 12.6% Brn3a+ cells coexpressing Pax6 (Fig. 4, L and M), suggesting that only a small fraction of the ABI-reprogrammed neurons are Brn3a+Pax6+ double-positive iRGCs and that most of them are Brn3a+ iSG neurons. Similarly, a small number of Brn3a+Pax6+ iRGCs were induced by AI (fig. S3, T and U).

In agreement with the induction of a small proportion of iRGCs by ABI, immunostaining showed that some cells outside the iSG were positive for Thy1.2 (Fig. 4E). qRT-PCR assays revealed a significant up-regulation of several commonly used RGC marker genes including the endogenous Brn3b, Brn3a, RPF-1, Pax6, Sncg, HuC, and HuD in MEFs infected with ABI lentiviruses compared to those infected with GFP viruses (Fig. 4J), consistent with the induction of iRGCs by ABI from MEFs. Moreover, during the time course of ABI reprogramming, we were able to show by qRT-PCR assay that Pax6 expression was progressively induced starting from day 9 (fig. S1E).

We further characterized the iSG neurons and iRGCs by bulk and single-cell transcriptome profiling. First, we carried out bulk RNA-seq analysis of ABI- and GFP-transduced MEFs after 2 weeks of induction (Fig. 5A). Scatter plot and hierarchical cluster analyses showed that there were numerous genes whose expression was down-regulated or up-regulated in ABI-transduced compared to GFP-transduced MEFs (fig. S6, A to C, and table S1). We performed gene set enrichment analysis (GSEA) of the altered genes followed by network visualization (31), and one major group of clustered networks emerged (fig. S6D). This group encompasses only up-regulated genes that are enriched for GO (gene ontology) terms relevant to neural function and development such as synaptic signaling, synaptic vesicle, synapse organization, neurotransmitter transport, regulation of neurotransmitter levels, exocytosis, calcium ion binding, ligand-gated channel activity, neuron projection, axon, and nervous system development. These results are consistent with the induction of functional SG and retinal ganglion neurons by ABI from MEFs. In agreement with this and qRT-PCR assays (Figs. 2, W and X, and 4J), bulk RNA-seq confirmed up-regulation of many SG and retinal ganglion genes in ABI-transduced MEFs, including NF200, Brn3a, TrkB, vGlut3, Trpv1, P2X3, Gria1, Pax6, Sox11, Sncg, and Thy1 (fig. S6, E and F).

(A) Schematic illustration of the processes for bulk RNA-seq and scRNA-seq analyses. (B) t-distributed Stochastic Neighbor Embedding (t-SNE) plot of the 15 cell clusters generated from the sequenced single iSG neurons. (C to J) t-SNE plots colored by expression of the indicated conventional SG marker genes. (K) Violin plots showing expression patterns of the indicated conventional SG marker genes in single-cell clusters.

We separated ABI-induced iSG from MEFs by mild dissociation and filtering and then carried out scRNA-seq analysis of single iSG cells using the 10 Genomics Chromium platform (Fig. 5A) (32). After processing the sequencing data by the Cell Ranger software pipeline, we clustered the 3231 sequenced single cells into 15 clusters using the Seurat software package (Fig. 5B), which is an R toolkit for single-cell genomics (33). Investigation of gene expression patterns showed high levels of expression of general neuronal marker genes such as Tuj1, Tau, and Map2 in clusters 1, 3, 5, 8, and 11, whereas they are expressed much more weakly in the rest of the clusters (fig. S7, A and C to E). By contrast, many of the previously identified MEF marker genes (34) including Klf4, Mmp2, and Postn have, in general, an opposite expression pattern, displaying little expression in clusters 1, 3, 5, 8, and 11 but obvious expression in the rest of the clusters (fig. S7, A and F to H). Pseudotime trajectory of the sequenced cells constructed using Monocle (35) yielded three presumptive states along which Klf4 expression progressively decreases, while the expression of Tuj1, Tau, and Map2 progressively increases (fig. S7, I and J). Thus, in iSG induced from MEFs by ABI for 2 weeks, there are still some cells that express both neuronal and MEF markers, suggesting that MEFs undergo a transitional intermediate stage that exhibits both MEF and neuronal characteristics before completely reprogrammed into mature iSG neurons (fig. S7B). Consistent with this idea, there were many cells coexpressing both Tuj1 and the fibroblast marker gene vimentin in a number of the clusters (fig. S7K). By days 6 to 12 of ABI reprogramming, we also detected by immunolabeling some cells and nerve bundles that were immunoreactive for both Tuj1 and vimentin proteins (fig. S7L).

Consistent with the induction of iSG neurons, there is expression of NF200, peripherin, p75NTR, TrkB, TrkC, Trpv1, Trpv2, P2X3, Accn2, Kcnq2, Cacna1a, and CGRP in various clusters of sequenced iSG cells (Fig. 5, C to K). In particular, NF200, P2X3, Accn2, Kcnq2, and Cacna1a are primarily expressed in clusters 1, 3, 5, 8, and 11, and peripherin, Trpv1, and Trpv2 are mainly present in a small number of cells in clusters 1, 3, and 5 (Fig. 5, C, D, F to I, and K), indicating their expression in mature iSG neurons and their expression specificity. Many genes that are markers for both SG neurons and RGCs, such as Thy1, Sncg, Rbpms, Gap43, HuC, Sox11, Sox12, Zeb2, Brn3a, Brn3c, and RPF-1, are also expressed in various clusters of sequenced iSG cells (Fig. 6). However, the RGC marker Pax6 is only enriched in small cell clusters 12 and 13 and expressed in few cells in other clusters, consistent with the observation that only a very small number of iSG cells were immunoreactive for Pax6 (Figs. 4C and 6I). The Pax6+ cells in clusters 12 and 13 do not appear to be iRGCs because they lack expression of RGC markers Brn3a, Brn3c, and RPF-1 (Fig. 6I). In agreement with the observation that iRGCs were scattered and rarely present in iSG, there are only a small number of cells coexpressing both Pax6 and Tuj1, Thy1, Gap43, HuC, Sox11, Brn3a, or RPF-1, primarily in clusters 5 and 6 (Fig. 4C and fig. S8, A to H).

(A to H) t-SNE plots colored by expression of the indicated conventional RGC marker genes. (I) Violin plots showing expression patterns of the indicated conventional RGC marker genes in single-cell clusters.

We reprogrammed human skin fibroblasts (HSFs) into iSG with a mixture of the three individual ABI lentiviruses only at a low efficiency. To increase the reprogramming efficiency, we created a Dox-inducible lentiviral construct containing Ascl1, Isl1, and Brn3b in a single open reading frame (ORF) tethered by the P2A and T2A self-cleaving peptide sequences (Fig. 7A). HSFs infected by these single ABI-expressing viruses readily formed well-networked iSG in approximately 45 days in the neural differentiation medium (Fig. 7B). Immunostaining of these iSG showed that they contained typical sensory neurons expressing TUJ1, MAP2, NF200, PERIPHERIN, SYNAPSIN, VGLUT1, TRKA, TRKB, TH, and BRN3A (Fig. 7, C to K). Moreover, similar to MEFs, a small number of iRGCs were induced from HSFs by ABI that were immunoreactive for both PAX6 and BRN3A (Fig. 7, L and M). qRT-PCR assays showed that TUJ1 expression was gradually induced by ABI starting from day 10 but the more mature neuron marker gene MAP2 was not induced until day 20 (Fig. 7N). In contrast, the fibroblast marker genes COL1A1 and TWIST2 were progressively down-regulated starting from day 10 (Fig. 7O), concurrent with TUJ1 induction.

(A) Schematic of the lentiviral construct. (B to M) Networked iSG induced by ABI from HSFs (B) and iSG and iRGCs double-immunostained with the indicated antibodies and counterstained with DAPI (C to M). (N to Q) qRT-PCR assay showing the time course [days 1 (D1) to 20 (D20)] of expression changes of the indicated marker genes in HSFs infected with ABI or GFP viruses (means SD, n = 4). *P < 0.0001 for (N), (P), and (Q) and *P < 0.01, **P < 0.001, ***P < 0.0001 for (O). hES, human embryonic stem cell; hiNSC, human neural stem cell. (R) Schematic of EdU labeling schedule. (S to U) ABI-transduced HSFs were labeled by EdU for 29 days and colabeled for both TUJ1 and EdU before (S) and after dissociation (T). (U) Corresponding quantification (means SD, n = 4). *P < 0.0001. (V to X) ABI-transduced HSFs were labeled by EdU for 24 hours and colabeled for both TUJ1 and EdU before (V) and after dissociation (W). (X) Corresponding quantification (means SD, n = 4). *P < 0.0001. (Y, Z, and A) Current-clamp recordings revealed single action potential responses (single-spiking) of a differentiated iSG neuron (Y). Voltage-clamp recordings of the same neuron indicated fast activated and inactivated inward sodium currents as well as outward potassium currents (Z and A). The sodium currents of the iSG neuron were effectively blocked by TTX and were partially restored by its washout (A). (B and C) Current-clamp recordings revealed an iSG neuron with multiple action potential responses (multiple-spiking). (D) Spontaneous postsynaptic currents recorded from a differentiated iSG neuron. Scale bars, 80 m (B) and 20 m (C to M, S, T, V, and W).

To determine whether iSG induction was mediated by a pluripotent or neural progenitor intermediate, we investigated by qRT-PCR assay expression of pluripotent factor genes and neural progenitor marker genes during HSF reprogramming by ABI. We found no significant change in expression levels of pluripotent factor genes OCT4, KLF4, and NANOG during the reprogramming process (from day 1 to day 20) (Fig. 7P). Similarly, there was no induction of NESTIN and OLIG2 expression in the reprogramming process (Fig. 7Q), suggesting that iSGs were reprogrammed from HSFs by ABI without an intermediate state of pluripotent or neural progenitors. Consistent with this, by day 30 of reprogramming, almost no reprogrammed TUJ1+ neurons were labeled by EdU when EdU was added to the reprogramming cell culture for 29 days or 24 hours (Fig. 7, R to X), confirming that iSG reprogramming occurred in the absence of an intermediate state of proliferative progenitors.

The electrophysiological properties of reprogrammed human iSG neurons were evaluated by whole-cell patch-clamp recording. At day 60, most neurons (15 of 17) exhibited typical sodium and potassium currents and showed action potential responses (Fig. 7, Y, Z, and A). In addition, the inward sodium current could be specifically and completely blocked by TTX and partially recovered by its removal (Fig. 7A). Similar to mouse iSG neurons, some (4 of 17) were multi-spiking, while the others (11 of 17) were single-spiking (Fig. 7, Y, B, and C), although in human iSG single-spiking neurons appeared to be more abundant than those in mouse iSG (Fig. 3K). Among all neurons recorded from day 25 to day 39, a small fraction (4 of 44) displayed spontaneous postsynaptic activities (Fig. 7D), indicating the ability for human iSG neurons to form functional synapses, in agreement with their synapsin labeling (Fig. 7F). Thus, the human iSG neurons induced by ABI from HSFs have the physiological properties characteristic of mature neurons.

We further investigated the ability of human iSG neurons to survive and integrate in the DRG by microinjecting GFP-tagged human iSG neurons into adult rat DRG explants (fig. S4A). Two weeks after transplantation, we found that the GFP+ neurons survived and integrated in the DRG, and were all (99 of 99) immunolabeled by an anti-human nuclei antibody (fig. S4F), indicating that material transfer did not occur between the transplanted and host cells. The transplanted GFP+ cells were immunoreactive for pan-sensory neuron markers, and some of them were immunoreactive for TrkA, TrkB, or TrkC (fig. S4, G to I), suggesting that similar to mouse iSG neurons, transplanted human iSG neurons can also survive in the DRG and maintain sensory neuron subtypes.

Although scattered sensory neurons (iSNs) were previously induced from fibroblasts by TFs (20, 21), to our knowledge, this is the first time to demonstrate that self-organized iSG organoids can be consistently induced directly from somatic cells by defined TFs. The bHLH TF Ascl1 has been shown to be a pioneer neurogenic TF in converting fibroblasts into neurons in in vitro somatic cell reprogramming (26). However, the neurons reprogrammed by Ascl1 alone are mostly slow-maturing and excitatory (36). Addition of Brn2 and Myt1l (BAM) improved the reprogramming efficiency, maturing speed, and varieties of the iNs (27, 36, 37). The iNs induced by BAM were rather generic but motor neurons could be specifically induced when BAM were combined with four other TFs (Lhx3, Hb9, Isl1, and Ngn2) (38). Similarly, when trying BAM with other combinations, Wainger et al. (20) found that the combination of five factors (Ascl1, Myt1l, Ngn1, Isl2, and Klf7) could successfully convert fibroblasts into nociceptor neurons. Notably, all of these reprogramming formulas include Ascl1 as a key component. Alternatively, the bHLH TFs Ngn1 and Ngn2 were combined with Brn3a to reprogram fibroblasts into mature iSNs (21).

Our experiments in this study have demonstrated that the ABI TF combination is most effective in inducing MEFs into self-organized mini-SG, while the AI and AB combinations have a weaker activity (fig. S8J). Thus, Brn3a/3b appears to act synergistically with Isl1 to improve the induction efficiency of iSG organoids. As revealed by time-lapse microscopy, the larger iSG organoids are formed by cell migration and coalescing smaller cell aggregates. The mini-SG induced from both murine and human fibroblasts contain mature and functional sensory neurons. They exhibit typical inward sodium currents, which can be blocked by TTX and recover after TTX removal, and are a mixture of neurons displaying multiple-spiking action potentials or single-spiking action potential. They also show calcium responses to potassium chloride, capsaicin, and menthol. All these features closely resemble their endogenous counterparts.

The iSG neurons reprogrammed by ABI display extensive cell diversities in their expression of characteristic receptors, ligands, ion channels, neuropeptides, neurotransmitters, and so on, similar to the endogenous sensory neurons. In agreement with iSNs induced by Ngn1/2 and Brn3a (21), the iSGs contain roughly equivalent percentages (~30%) of TrkA+, TrkB+, and TrkC+ neurons, supporting the notion that Trk receptors may arise in a stochastic manner such that each donor cell has an approximately equivalent chance to express one of the Trk receptor genes. By bulk RNA-seq, scRNA-seq, and/or qRT-PCR analyses, we investigated the characteristic markers involved in sensory signaling pathways including transduction, conduction, and synaptic transmission of sensory signals. At the transduction level, we found up-regulated expression of genes responsible for perceptions to stimuli such as heat (Trpv1, Trpv2, Trpv3), cold (Trpa1), damage (P2X3, Bdkrb1), and touch (Trpc1, Trpc4, Asic2/Accn1, Accn2). Trpv1, also known as capsaicin receptor that is expressed mainly in the nociceptive neurons (29), has been shown to be present and functional in iSG neurons by capsaicin stimulation. The signaling conduction of sensory neurons is primarily mediated by sodium channels, which propagate the signals, and potassium channels, which usually act to reduce excitability. We found that the expression of many Na+ channels (Scn1a, 2a1, 2b, 3a, 3b, 7a, 11a) and K+ channels (Kcnq2, 4; Kcna2, 3, 4, 5, 6; Kcnb2, c1, d2, e4, f1, h2, j2, k3, s3, t1, etc.) were up-regulated in iSG neurons. For synaptic transmission, neurotransmitter receptors and presynaptic voltage-gated Ca2+ channels are two groups of important regulatory molecules. Correspondingly, the expression of a variety of neurotransmitter receptors (Nk1r, Nr3c2; Gria1, 2, 4; Grid1, k1, k2, k4, k5; Grin1, 2a, etc.) and Ca2+ channels (Cacna1a, 1b, 1d, 2d1, 2d2, 2d3; Cacnb1, g4, etc.) were significantly up-regulated in iSG neurons.

Apart from the molecular and electrophysiological properties, ABI-reprogrammed iSG neurons also have salient cellular and innervation characteristics of sensory neurons. For instance, when transplanted, they can survive, integrate, and maintain the nociceptive, mechanoreceptive, and proprioceptive subtypes in the DRG. Moreover, the iSG neurons exhibit strong affinity for endogenous DRG neurons and spontaneously aggregate with them to form interconnected DRG-like organoids in culture. In addition, we have demonstrated by coculture that the iSG neurons have the capacity to innervate the peripheral targets of sensory neurons, i.e., epidermal cells, indicating that the iSGs contain bona fide sensory neurons reprogrammed from fibroblasts by ABI.

Therefore, the combination of ABI TFs is able to reprogram murine and human fibroblasts into self-organized iSG organoids composed of heterogeneous sensory neurons, closely resembling the endogenous SG. Previously, Ascl1 in combination with Brn3a, Brn3b, or Brn3c was shown to induce iNs from MEFs (39). Although the sensory neuron identity of the iNs was not investigated, some of the data suggest the formation of iSG organoids by the Ascl1 and Brn3a combination (39). This is consistent with our work that showed that the AB combination enabled induction of iSG organoids, albeit fewer than those induced by the ABI combination (Fig. 1). Similarly, the data reported in a previous study also suggest the formation of iSG organoids by the nociceptive neurons reprogrammed from MEFs using a 5-TF combination (20). However, unlike the ABI combination, the 5-TF combination did not appear to induce iSG organoids from human fibroblasts (20), suggesting a difference in reprogramming capacity and/or efficiency by different combinations of TFs.

The peripheral ganglia, including cranial ganglia, DRG, trigeminal ganglia, enteric system ganglia, autonomic ganglia, and others, are derived from migrating NC cells. The NC is thought to be a unique cell population found in vertebrates and is initially induced at the neural plate border as a result of neural plate folding and fusion (40). After undergoing an epithelial-to-mesenchymal transition, the NC cells delaminate from the neuroepithelium and become highly migratory. Most NC cells migrate as a chain or group in a so-called collective cell migration, in which cell contact and cooperation allow them to migrate directionally. Guided by local cues and long-range chemoattractants, NC cells reach their destination and differentiate into ganglia and other tissue types.

Mutations in crucial genes controlling the migration and differentiation of NC cells may cause aganglionosis such as Hirschsprungs disease, which may occur by itself or in association with other genetic disorders such as Down syndrome, Waardenburg-Shah syndrome, Mowat-Wilson syndrome, or Bardet-Biedl syndrome (41). This group of genes includes RET, ZEB2, EDNRB, SOX10, and PHOX2B, and mutations of them or their regulatory sequences may increase the risk of Hirschsprungs disease more than 1000-fold (41). In our RNA-seq data, the expression of Ret, Zeb2, Ednrb, and Sox10 was significantly up-regulated in the iSG neurons, in agreement with their importance in the differentiation and formation of SG. Other known risk genesBbs4, Bbs10, Edn3, Gfra1, and Arvcf (41)were also significantly elevated in iSG. The hereditary sensory and autonomic neuropathies (HSANs) consist of several clinically heterogeneous disorders characterized by defective development and maintenance, and progressive degeneration of sensory and autonomic nervous systems. Mutations in the SPTLC1, WNK1, IKBKAP, and TRKA genes have been shown to cause HSAN types I to IV, respectively (42). In addition, loss-of-function mutations in SCN9A and PRDM12 result in congenital insensitivity to pain (6, 43). Indifference to pain appears to be desirable but risks the loss of a vital protective mechanism with dangerous consequences such as unknowingly chewing tongues and lips and damaging digits and joints. On the other hand, pain hypersensitivity reduces the quality of life and may increase susceptibility to chronic pain.

The ability to reprogram somatic cells into iSG organoids by ABI presents new possibilities for modeling sensorineural diseases, studying their pathogenesis, screening for counteractive drugs, and developing cell replacement therapies. For example, patient-derived iSG organoids may be used as an in vitro model for pain to screen and evaluate potential drug treatments. In the future, iSG organoids and neurons may also be used in transplantation as a cell replacement therapy for damaged or degenerated SG. In this respect, we found that transplanted iSG neurons were able to integrate and maintain the nociceptive, mechanoreceptive, and proprioceptive subtypes in the DRG. It has long been recognized that genetic factors are a major contributor to personalized pain perception and the efficacy of analgesic drugs (29). Generation of iSG organoids from autologous somatic cells may thus provide an exciting novel approach to model personalized pain and sensory pathology and help to achieve precision medicine for pain.

In this study, we made efforts to define specific molecular markers to identify RGCs both in vitro and in vivo. This is important because it is impossible to apply commonly used RGC markers to distinguish RGCs from SG neurons in vitro given the high molecular similarity between these two cell types. Since the 1990s, we have established the Brn3 family of TFs, Brn3a, Brn3b, and Brn3c, as the gold standards to identify RGCs in the retina (10, 15). However, Brn3 proteins are not unique to the retina but expressed in other sensory and CNS tissues as well, e.g., trigeminal ganglia, DRG, spiral ganglia, and midbrain (10, 15, 44). Apart from Brn3 proteins, Thy1.2, Sncg, and Rbpms are also commonly used as specific RGC markers. But here again, we show their abundant expression in DRG neurons. Therefore, although because of the spatial separation of the retina from SG in the organism, these so called RGC-specific markers are able to distinguish RGCs from SG neurons in vivo, they are unable to do so in vitro. Unfortunately, however, a number of previous studies used these supposedly RGC-specific markers to identify RGCs induced from ESCs, iPSCs, and somatic cells in vitro (2225), casting doubt on some of the arrived conclusions.

To avoid misidentifying iRGCs and iSG neurons in vitro, we screened for molecular markers that can definitively distinguish RGCs from SG neurons. A rigorous criterion was set that these unique identifiers should be single-molecule markers or a combination of multiple-molecule markers that must be present only in RGCs within the retina but not in SGs or any other tissues. Following a careful examination of a large number of known RGC and SG neuron markers, it became apparent that none of them alone were specific to RGCs. Further double-immunolabeling analysis indicated that a combination of Pax6 and Brn3a or Brn3b double markers satisfied the criterion of specific RGC identifiers. Brn3a+Pax6+ and Brn3b+Pax6+ double-positive cells were found exclusively in RGCs of the retina but not in the DRG, spinal cord, midbrain, or cerebellum, where Brn3a, Brn3b, or Pax6 is normally expressed. Moreover, scRNA-seq analysis confirmed Brn3a+Pax6+ and Brn3b+Pax6+ cells as RGCs and their complete absence in the DRG. Thus, we are able to define the combination of Pax6 with either Brn3a or Brn3b double protein markers as specific identifiers for RGCs. Armed with this knowledge, we found that ABI TFs had the capacity to reprogram MEFs into a small number of Brn3a+Pax6+ iRGCs, representing about 13% of all Brn3a+ neurons. Unlike iSG organoids resembling endogenous SG, iRGCs did not coalesce into clusters but remained scattered, similar to the dispersive distribution pattern of endogenous RGCs in the retina (fig. S8, I and J). Therefore, ABI-induced iSG and iRGCs maintain the morphology characteristic of their endogenous equivalents.

In summary, in a screen of multiple SG and RGC TFs, we have identified a triple-factor combination ABI as the most efficient combination to reprogram self-organized and networked iSG organoids from mouse and human fibroblasts. By immunostaining, qRT-PCR, whole-cell patch-clamp recording, calcium imaging, and bulk and scRNA-seq approaches, we are able to demonstrate that the iSG organoids display molecular and cellular features, subtype diversity, electrophysiological properties, and peripheral innervation patterns characteristic of peripheral SGs. Furthermore, using immunolabeling and scRNA-seq analyses, we have identified bona fide RGC-specific molecular markers to demonstrate that the ABI combination has the additional capacity to induce from fibroblasts a small number of iRGCs. Unlike the ABI-reprogrammed iSG organoids characteristic of endogenous SG, iRGCs maintain a dispersive distribution pattern resembling that of endogenous RGCs in the retina. The iSG organoids and iRGCs may be used to model sensorineural/retinal diseases, to screen for effective drugs and potentially, as cell-based replacement therapy.

All experiments on rodents were performed according to the IACUC (Institutional Animal Care and Use Committee) standards and approved by Sun Yat-sen University and Zhongshan Ophthalmic Center. The C57BL/6 mice were purchased from the Vital River Laboratories (Beijing, China).

The full-length ORFs of Brn3a, Brn3b, Isl1, Math5, Ebf1, Pax6, Tfap2a, Nr4a2, Nrl, Crx, Ptf1a, Neurod1, Lhx2, Ngn1, Ngn2, Chx10, Sox2, Rx, Meis1, Foxn4, Otx2, Sox9, or Six3 were subcloned into the Eco RI site of the FUW-TetO vector (45). In addition, by overlapping PCR subcloning, Ascl1, Isl1, and Brn3b were tethered by P2A and T2A self-cleaving peptide sequences into a single ORF, which was inserted into the same FUW-TetO backbone. Lentiviruses were prepared as previously described (34).

The MEFs were prepared as previously described (34). For isolation of mouse epidermal cells, P0 C57BL/6 mice were anesthetized with ice for 5 min and the brain was removed using a sterilizing razor in a 10-cm culture dish containing Hanks balanced salt solution (HBSS) (Gibco). The epidermis was isolated from the remaining tissue using a pair of fine-tip forceps under a dissection microscope, transferred into a fresh 6-cm culture plate containing 1 ml of 0.25% trypsin, thoroughly minced using a pair of surgical scissors and forceps, and incubated for 15 min at 37C in a CO2 incubator. Six-milliliter MEF medium containing Dulbeccos modified Eagles medium (DMEM)/High Glucose (HyClone) supplemented with 10% fetal bovine serum (Gibco), 1 penicillin/streptomycin (Gibco), 1 MEM nonessential amino acids (NEAA) (Gibco), and 0.008% (v/v) 2-mercaptoethanol (Sigma-Aldrich) was added into the plate to terminate the reaction. After being mixed using a 10-ml pipette, the digested tissue was transferred to a 15-ml fresh tube, centrifuged at 1000 rpm for 5 min, and resuspended in 5-ml fresh MEF medium. The isolated epidermal cells were expanded by culture in the MEF medium at 37C in a CO2 incubator. The HSFs were purchased from the American Type Culture Collection (CRL1502, 12-week gestation). MEFs, mouse epidermal cells, and HSFs were all maintained and expanded in the MEF medium.

To induce iSG and iRGCs from MEFs, 3 104 MEF cells (at passage 3) were cultured in 500-l MEF medium in a well of a 24-well plate containing a glass coverslip precoated with Matrigel (Corning). They were infected the next day with 500-l mixture of lentiviruses and fresh MEF medium in the presence of polybrene (10 g/ml). After 16-hour infection, the virus and medium mixture was removed. The cells were induced for 4 days in the neuron basic medium [(DMEM/F12 (1:1) (Life Technologies) supplemented with 1 B27 (Gibco) and basic fibroblast growth factor (bFGF) (10 ng/ml) (R&D Systems)] in the presence of Dox (2 ng/ml) (Sigma-Aldrich) and then for another 4 days in the neuron maintenance medium containing the neuron basic medium supplemented with insulin-like growth factor 1 (IGF-1) (100 ng/ml), brain-derived neurotrophic factor (BDNF) (10 ng/ml), and glial cell linederived neurotrophic factor (GDNF) (10 ng/ml) in the presence of Dox (2 g/ml). The medium was replaced with the neuron maintenance medium without Dox following the 8-day induction period. By 14 days after infection with Ascl1, Brn3b/3a, and Isl1 (ABI), Ascl1 and Brn3b/3a (AB), or Ascl1 and Isl1 (AI) lentiviruses, many visible neuronal clusters were formed.

With modifications, the HSFs were similarly induced. In brief, after virus infection, the human cells were cultured in the neuron basic medium with Dox for 10 days and then in the neuron maintenance medium without Dox for another 10 days. On day 21, the medium was replaced with the neuron mature medium, which is the maintenance medium supplemented with NGF (20 ng/ml), NT-3 (20 ng/ml), and 10 M forskolin. Thirty days after viral infection, many neuronal clusters were visible, which were usually smaller than those induced from MEFs. To improve the induction efficiency of the HSFs, we created a Dox-inducible lentiviral construct containing Ascl1, Isl1, and Brn3b in a single ORF as described above.

RNA extraction and qRT-PCR analysis were carried out as previously described (34). The qRT-PCR primers used are shown in table S2.

Immunostaining of tissue sections and cells was carried out as previously described (34, 46). The following antibodies (with dilution information) were used: mouse anti-Brn3a (Santa Cruz Biotechnology, sc-390780; 1:1000), mouse anti-Brn3a (Santa Cruz Biotechnology, sc-8429; 1:100), goat anti-Brn3b (Santa Cruz Biotechnology, sc-6026; 1:1000), rat anti-Thy1.2 (BD Biosciences, 550543), goat antiRPF-1 (Santa Cruz Biotechnology, sc-104627; 1:100), rabbit anti-Rbpms (PhosphoSolutions, 1830-RBPMS; 1:500), mouse anti-HuC&D (Life Technologies, A-21271; 1:500), rabbit anti-Pax6 (BioLegend, 901301; 1:2000), mouse anti-Pax6 (Developmental Studies Hybridoma Bank, Pax6; 1:1000), rabbit anti-Six6 (Sigma-Aldrich, HPA001403; 1:500), rabbit anti-Ebf (Santa Cruz Biotechnology, sc-33552; 1:1000), mouse anti-Isl1 (Abcam, ab20670; 1:2000), rabbit anti-Zeb2 (Santa Cruz Biotechnology, sc-48789; 1:1000), rat anti-Lmo4 (1:1000; (47), rabbit anti-Ldb1 (Abcam, ab96799; 1:1000), rabbit anti-Sncg (GeneTex, GTX110483; 1:200), rabbit anti-CGRP (Neuromics, RA24112; 1:200), rabbit anti-peripherin (Millipore, ab1530; 1:1000), rabbit anti-vGLUT1 (Synaptic System,135303; 1:500), mouse anti-vGLUT2 (Abcam, ab79157; 1:500), mouse anti-vGLUT3 (Sigma-Aldrich, SAB5200312; 1:500), rabbit anti-GABA (Sigma-Aldrich, A-2052; 1:1000), goat anti-TrkA (Abcam, ab76291; 1:500), rabbit anti-TrkA (Abcam, ab76291; 1:500), goat anti-TrkB (R&D Systems, AF1494; 1:500), goat anti-TrkC (R&D Systems, AF1404; 1:500), rabbit anti-P2X3 (Millipore, AB5895; 1:100), mouse anti-Tuj1 (Millipore, MAB5564; 1:500), rabbit anti-Tuj1 (Abcam, ab18207; 1:2000), mouse anti-Map2 (Sigma-Aldrich, M1406; 1:2000), rabbit anti-synapsin (Calbiochem, 574778; 1:500), goat anti-Dcx (Santa Cruz Biotechnology, sc-8066; 1:500), mouse anti-NF200 (Millipore, MAB5266; 1:500), rabbit anti-TH (Protos Biotech, CA-101bTHrab; 1:1000), rabbit anti-Vamp (Synaptic System, 104203; 1:500), rabbit anti-p75NTR (Abcam, ab8874; 1:500), mouse anti-c-Ret (Sigma-Aldrich, o4886; 1:1000), goat anti-GFP (Abcam, ab6673; 1:2000), rabbit anti-GFP (MBL, 598; 1:2000), chicken anti-GFP (Abcam, ab13970; 1:2000), rabbit anti-vimentin (Abcam, ab92547; 1:2000), and mouse anti-human nuclei (Millipore, MAB1281; 1:200). The secondary antibodies used included donkey anti-rabbit, donkey anti-goat, and donkey anti-mouse Alexa 488 immunoglobulin G (IgG), Alexa 594 IgG, Alexa 546 IgG, Alexa 647 IgG, or Alexa 594 IgM (1:1000; Invitrogen). 4,6-Diamidino-2-phenylindole (DAPI) (Invitrogen) was used for nuclear counterstaining. Images were captured with a laser scanning confocal microscope (Carl Zeiss, LSM700).

One day following infection with ABI lentiviruses, the MEFs were cultured in the presence of 10 M EdU (Life Technologies) for 13 days, or 13 days after infection with AI or ABI viruses, the MEFs were cultured for 24 hours in the presence of 10 M EdU. The cells were then fixed, and EdU staining was carried out according to the manufacturers instruction (Life Technologies). For HSF reprogramming by ABI, EdU was added to the reprogramming cell culture for 29 days starting from day 1 of reprogramming or for 24 hours starting at day 29. Images were captured with a confocal microscope.

For time-lapse recording, we used the JuLI Stage (NanoEntek) with a motorized stage, computer-controlled lens change, and a built-in incubator that supplied humidified 5% CO2 at 37C for live cell recording. MEFs (5 104) derived from the CAG-GFP transgenic mice (28) were induced for 10 days by infection with the ABI lentiviruses or Ascl1 lentiviruses in a well of a 12-well plate precoated with Matrigel. The plate was then placed into the incubator of the JuLI Stage for time-lapse recording for 50 hours. A series of pictures were taken from each well of the 12-well plate in a period of 50 hours under the control of the JuLI EDIT software, which can also edit and replay these pictures in a continuous mode like a movie.

To prepare single iSG cells, MEFs were infected with the ABI (Ascl1, Brn3b, and Isl1) lentiviruses and induced for 2 weeks. Following addition of 500-l Accutase (Millipore) into a well of a 12-well plate, neuronal clusters were suspended by gently pipetting up and down several times using a 1-ml pipette and transferred into a 70-m cell strainer (Falcon) to collect neuronal clusters. Most neuronal clusters attached to the Nylon membrane of the 70-m cell strainer, which was cut from the cell strainer using a pair of scissors and placed into a low-adhesion 6-cm plate containing 4-ml neuron basic medium. To separate the neuronal clusters from the Nylon membrane, the plate was shaken left and right 10 times. The neuronal clusters were then transferred into a 15-ml tube, centrifuged at 1000 rpm for 5 min, resuspended with 1-ml Accutase, and incubated for 5 min at 37C in a CO2 incubator. The neuronal clusters were dissociated into many single cells, which were subsequently used for injection of DRG explants, qRT-PCR, and scRNA-seq analysis.

After euthanization of the rat by the asphyxiation method (CO2 inhalation), the vertebral columns were isolated from the rest of the tissue using a pair of sharp scissors and washed three times with HBSS in a 10-cm culture dish. Both sides of the vertebral columns were mounted onto a surgical mat using needles, and a double cut was made using a pair of surgical scissors to expose the ventral side of the spinal cord. After removal of the spinal cord, DRGs were exposed in the contralateral dorsal spinal roots and pulled out using a pair of fine tweezers. They were collected into a 6-cm culture dish containing HBSS after removal of the attached excessive fibers and connective tissues under a dissection microscope. Four DRGs were transferred onto a Millipore Millicell-CM Low Height Culture Plate Insert using a 3-ml Pasteur pipette, and the rest of HBSS was removed using a 200-l pipette. Then, the insert was placed into a well of a six-well plate containing 1-ml DRG culture medium [BEM (Gibco) supplemented with 20 mM glucose, 1 KIT (Gibco), putrescine (16 ng/ml) (Sigma-Aldrich), 10 mM vitamin C (Sigma-Aldrich), NGF (20 ng/ml) (PeproTech), and 10 mM 5-fluoro-2-deoxyuridine (FDU) (Sigma-Aldrich)]. After being cultured for 1 day, each DRG was injected with 4 103 GFP-labeled single iSG cells. Two weeks following iSG cell injection, the explants were processed and immunostained as described above.

Whole-cell patch-clamp recordings of the iNs were performed with the EPC 10 USB amplifier (HEKA Electronik, Lambrecht, Germany) as previously described (34). Neurons induced from MEFs for 9 or 14 days or from HSFs for 25 to 60 days were used for patch-clamp recordings. In brief, coverslips with adhered cells were transferred into a recording chamber and bathed with Ringers containing 125 mM NaCl, 2.5 mM KCl, 1 mM MgSO4, 2 mM CaCl2, 1.25 mM NaH2PO4, 26 mM NaHCO3, and 20 mM glucose, bubbled with 95% O2 and 5% CO2. Cell responses were recorded with 6- to 9-megohm resistance pipettes that were filled with an internal solution containing 105 mM K-gluconate, 5 mM KCl, 5 mM NaOH, 15 mM KOH, 0.5 mM CaCl2, 2 mM MgCl2, 5 mM EGTA, 2 mM adenosine 5-triphosphate, 0.5 mM guanosine 5-triphosphate, 10 mM Hepes, and 2 mM ascorbate (pH 7.2). The cells and recording pipettes were viewed on a monitor that was coupled to a charge-coupled device camera (Evolve, Photometrics, Tucson, USA) mounted on an upright microscope. Oxygenated external solution was continuously perfused into the recording chamber at a flow rate of 1.5 to 2 ml/min by a peristaltic pump (LEAD-2, Longer Pump, Hebei, China). Capacitive transients were compensated via the Patch Master software (PatchMaster, HEKA), and the series resistance was compensated by ~50%. For current-clamp recording, a small, constant holding current was injected to maintain resting membrane potential (Vrest) at 70 mV and current pulses with a step size of 10 pA were applied to induce action potentials. Voltage-clamp recordings were performed on the same cells directly following current clamp recordings. A simple step protocol from 90 to +30 mV for 200 ms was applied to assess the voltage-gated sodium channels and voltage-gated potassium channels. TTX (Tocris, USA) was added to the bath solution to a final concentration of 0.5 M and perfused into the recording chamber for 5 min. After recording of the currents again, TTX was washed out, followed by the third time of recording.

The fluorescent probe Fluo-8 AM (AAT Bioquest, Sunnyvale, Canada) was used to detect the changes of intracellular calcium. As described above, MEFs were induced for 2 to 3 weeks to form neuronal clusters by infection with the ABI lentiviruses. Under dark environment, glass coverslips with adhered neuronal clusters were loaded with Fluo-8 AM (10 m) for 25 to 30 min at room temperature. After three rinses with Ringers solution, the coverslip was placed into a recording chamber. An upright microscope (Olympus, BX51W1) equipped with a mercury lamp with a 488-nm filter was used to excite Fluo-8. A digital camera (Hamamatsu Photonics, Japan) that was also equipped on the microscope was used to record the fluorescent signal. The software HCImage Live (Hamamatsu Corporation, USA) was used to control the camera and ImageJ for data analysis. Following a 30-s recording of the baseline (F0), 100 mM KCl was puffed to detect the activity of the cells. After a 2-min wash with Ringers, fluorescent signals were decreased to the baseline. Then, 100 M menthol or 10 M capsaicin was puffed to stimulate the iNs. KCl (100 mM KCl) was applied again after menthol/capsaicin to confirm the viability of the tested cells. Only the cells that responded to KCl two times successively were chosen for analysis.

Bulk RNA-seq analysis was performed with modification as previously described (48). Two weeks after infection of MEFs with lentiviruses, total RNA was extracted from GFP-transduced and ABI (Ascl1, Brn3b, and Isl1)transduced MEFs using the TRIzol reagent according to the manufacturers instruction. Ribosomal RNA was depleted before preparation of RNA-seq libraries, which were subsequently sequenced using an Illumina HiSeq 4000 sequencer (Biomarker Technologies, China). The obtained sequence reads were trimmed and mapped to the mouse reference genome (mm10) using HISAT2 (https://daehwankimlab.github.io/hisat2/), and gene expression and changes were analyzed using Cufflinks and Cuffdiff. Hierarchical cluster and scatter plot analyses of gene expression levels were performed using the R software (http://cran.r-project.org). GSEA was carried out as described (31), which was followed by network visualization in Cytoscape using the EnrichmentMap plugin (https://enrichmentmap.readthedocs.io/en/latest/).

Single iSG cells were prepared as described above. Single adult mouse DRG cells were prepared as described previously (49). In brief, DRGs were collected, transferred into a low-adhesion 6-cm pate with 2 ml of DMEM/F12 medium containing collagenase IV (1.25 mg/ml), and incubated at 37C in a 5% CO2 incubator for 50 min. Then, the medium was replaced with 2-ml DMEM/F12 medium containing 0.025% trypsin and incubated for 30 min. Following the addition of 2-ml DMEM/F12 medium containing 33% fetal bovine serum, all the medium was removed using a 10-ml pipette. After being washed three times with 2-ml HBSS, the DRGs were transferred into a 1.5-ml tube containing 1.2-ml DMEM/F12 and triturated by pipetting up and down several times using a 1-ml pipette to obtain single DRG cells. A Brn3b-GFP reporter mouse line was created using the CRISPR-Cas9 gene editing system to label adult RGCs by GFP, which were enriched by fluorescence-activated cell sorting. A more detailed description of this mouse line and RGC enrichment procedure will be published elsewhere.

The number and viability of prepared single cells were quantified using Countess II (Thermo Fisher Scientific, AMQAX1000). Next, single-cell libraries were generated with the Chromium Single Cell 3 V2 Chemistry Library Kit, Gel Bead & Multiplex Kit, and Chip Kit from 10x Genomics. In brief, cell suspension at concentration of 1.2 million/ml was loaded in a Single Cell 3 Chip along with the RT Single Cell 3 Gel Beads and the Partitioning oil, and Single Cell Gel Bead-In-Emulsions were generated in the Chromium Controller. Reverse transcription reaction was run to obtain complementary DNA (cDNA), which was amplified by PCR. To generate the libraries, Enzymatic Fragmentation, End Repair, and A-tailing Double Sided Size Selection were used to incorporate the barcodes and index read sequences. The libraries were qualified by bioanalyzer (Agilent Technologies) and quantified by a Qubit dsDNA High Sensitivity Assay kit (Invitrogen) and then sequenced on Illumina X Ten platform in 150 paired-end configuration.

Raw reads were processed using the 10x Genomics Cell Ranger pipeline (https://support.10xgenomics.com/single-cell-gene-expression/software/downloads/latest) with the mm10 as the reference. Cell Ranger can cluster the single cells, identify the marker genes of each cluster, and export a matrix with unique molecular identifier (UMI) values of each gene in a single cell. The R software package Seurat (https://satijalab.org/seurat, version 2.2) (33) was used for further analysis. Default parameters were used for most of the Seurat analyses. For the FeaturePlot function, max.cutoff was 0.5. The pseudotime trajectory analysis of iSG cells was performed using Monocle 2 (http://cole-trapnell-lab.github.io/monocle-release/) (35).

Statistical analysis was performed using the GraphPad Prism 7 and Microsoft Excel computer programs. The results are expressed as means SD for experiments conducted at least in triplicates. Unpaired two-tailed Students t test or one-way analysis of variance test were used to assess differences between two groups, and a value of P < 0.05 was considered statistically significant.

Acknowledgments: We thank E. Shiang for help with the artwork. Funding: This work was supported, in part, by the National Natural Science Foundation of China (81670862, 81721003, 31871497, 81870682, and 31700900), National Key R&D Program of China (2017YFA0104100, 2018YFA0108300, and 2017YFC1001300), National Basic Research Program (973 Program) of China (2015CB964600), Local Innovative and Research Teams Project of Guangdong Pearl River Talents Program, Science and Technology Planning Projects of Guangzhou City (201904020036 and 201904010358), China Postdoctoral Science Foundation (2019 M650223), and the Fundamental Research Funds of the State Key Laboratory of Ophthalmology, Sun Yat-sen University. Author contributions: D.X., K.J., Y.S., and M.X. conceived and designed the research. D.X., Q.D., Y.G., X.H., M.Z., J.Z., P.R., Z.X., Y.L., and Y.H. performed the experiments and analyzed the data. D.X., K.J., and M.X. interpreted the data and wrote the manuscript. All authors contributed to critical reading of the manuscript. Competing interests: The authors declare that they have no competing interests. Data and materials availability: All data needed to evaluate the conclusions in the paper are present in the paper and/or the Supplementary Materials. Additional data related to this paper may be requested from the authors. The RNA-seq and scRNA-seq data have been deposited in the NCBI Gene Expression Omnibus database under accession codes PRJNA595403 and PRJNA597624, respectively.

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Generation of self-organized sensory ganglion organoids and retinal ganglion cells from fibroblasts - Science Advances

Hesperos Human-on-a-Chip System Used to Model Preclinical Stages of Alzheimer’s Disease and Mild Cognitive Impairment – Business Wire

ORLANDO, Fla.--(BUSINESS WIRE)--Hesperos Inc., pioneers of the Human-on-a-Chip in vitro system, today announced a new peer-reviewed publication that describes how the companys functional Human-on-a-Chip system can be used as a drug discovery platform to identify therapeutic interventions targeting the preclinical stages of Alzheimers disease (AD) and mild cognitive impairment (MCI). The manuscript, titled A human induced pluripotent stem cell-derived cortical neuron human-on-a-chip system to study A42 and tau-induced pathophysiological effects on long-term potentiation, was published this week in Alzheimer's & Dementia: Translational Research & Clinical Interventions. The work was conducted in collaboration with the University of Central Florida and with David G. Morgan, Ph.D., Professor of Translational Neuroscience at Michigan State University, and expert in AD pathology.

To date, more than 100 potential therapeutics in development for AD have been abandoned or failed during clinical trials. These therapeutics relied on research conducted in preclinical animal studies, which often are unable to accurately capture the full spectrum of the human disease phenotype, including differences in drug metabolism and excretion between humans and animals. Therefore, there is a need for human models, especially those that accurately recapitulate the functional impairments during the preclinical phases of AD and MCI.

Hesperos offers a breakthrough technology that provides a human cell-based assay based on cognitive function metrics to evaluate drugs designed to restore cognition at early stages of the Alzheimers continuum, said Dr. Morgan. This system can serve as a novel drug discovery platform to identify compounds that rescue or alleviate the initial neuronal deficits caused by A1-42 and/or tau oligomers, which is a main focus of clinical trials.

In 2018, Hesperos received a Phase I Small Business Innovation Research (SBIR) grant from the National Institute on Aging (NIA) division within the US National Institutes of Health (NIH) to help create a new multi-organ human-on-a-chip model for testing AD drugs. Research conducted under this grant included a study to assess therapeutic interventions based on functional changes in neurons, not neuronal death.

In the recent Alzheimer's & Dementia publication, Hesperos describes its in vitro human induced pluripotent stem cell (iPSC)-derived cortical neuron human-on-a-chip system for the evaluation of neuron morphology and function after exposure to toxic A and tau oligomers as well as brain extracts from AD transgenic mouse models.

Researchers are now focusing on biomarker development and therapeutic intervention before symptoms arise in AD and MCI, said James Hickman, Ph.D., Chief Scientist at Hesperos and Professor at the University of Central Florida. By studying functional disruption without extensive cell loss, we now have a screening methodology for drugs that could potentially evaluate therapeutic efficacy even before the neurodegeneration in MCI and AD occurs.

The researchers found that compared to controls, treatment with toxic A and tau oligomers or brain extracts on the iPSC cortical neurons significantly impaired information processing as demonstrated by reduction in high-frequency stimulation-induced long-term potentiation (LTP), a process that is thought to underlie memory formation and learning. Additionally, oligomer and brain extract exposure led to dysfunction in iPSC cortical neuron electrophysiological activity, including decreases in ion current and action potential firing.

While exposure to the toxic oligomers and brain extracts caused morphological defects in the iPSC cortical neurons, there was no significant loss in cell viability.

Clinical success for AD therapies has been challenging since preclinical animal studies often do not translate to humans, said Michael L. Shuler, Ph.D., Chief Executive Officer of Hesperos. With our recent study, we are now one step closer in developing an AD multi-organ model to better evaluate drug metabolism in the liver, penetration through the blood-brain barrier and the effects on neuronal cells.

About Alzheimers Disease/Preclinical Stage AD

AD is a progressive disease that is characterized by memory loss and deterioration of cognitive function. Preclinical AD is the first stage of the disease, and it begins long before any symptoms become apparent. It is thought that symptoms do not manifest until there is a significant death of neuronal cells, which is caused by the aggregation of toxic amyloid beta (A) and tau oligomers, typically during the earliest stages of the disease. Unfortunately, treatment after the diagnosis of MCI may be too late to reverse or modify disease progression.

To read the full manuscript, please visit https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/trc2.12029.

About Hesperos

Hesperos, Inc. is a leading provider of Human-on-a-Chip microfluidic systems to characterize an individuals biology. Founders Michael L. Shuler and James J. Hickman have been at the forefront of every major scientific discovery in this realm, from individual organ-on-a-chip constructs to fully functional, interconnected multi-organ systems. With a mission to revolutionize toxicology testing as well as efficacy evaluation for drug discovery, the company has created pumpless platforms with serum-free cellular mediums that allow multi-organ system communication and integrated computational PKPD modeling of live physiological responses utilizing functional readouts from neurons, cardiac, muscle, barrier tissues and neuromuscular junctions as well as responses from liver, pancreas and barrier tissues. Created from human stem cells, the fully human systems are the first in vitro solutions to accurately predict in vivo functions without the use of animal models. More information is available at http://www.hesperosinc.com.

Hesperos and Human-on-a-Chip are trademarks of Hesperos Inc. All other brands may be trademarks of their respective holders.

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Hesperos Human-on-a-Chip System Used to Model Preclinical Stages of Alzheimer's Disease and Mild Cognitive Impairment - Business Wire

AgeX Therapeutics and Sernova to Collaborate to Engineer Universal Locally Immune Protected Cell Therapies for Type I Diabetes and Hemophilia A -…

ALAMEDA, Calif. & LONDON, Ontario--(BUSINESS WIRE)--AgeX Therapeutics, Inc. (AgeX: NYSE American: AGE), a biotechnology company developing therapeutics for human aging and regeneration, and Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-stage regenerative medicine therapeutics company, announced today a research collaboration where Sernova will utilize AgeXs UniverCyteTM gene technology to generate immune-protected universal therapeutic cells for use in combination with Sernovas Cell PouchTM for the treatment of type I diabetes and hemophilia A. The goal is to eliminate the need for immunosuppressive medications following Cell Pouch cell transplantation.

The research collaboration will evaluate whether Sernovas pluripotent stem cell-derived pancreatic islet beta cells engineered with AgeXs UniverCyte technology can evade human immune detection. The complementary combination of technologies could enable the transplantation of therapeutic cells in patients with type I diabetes in an off-the-shelf manner using Sernovas Cell Pouch, without human leukocyte antigen (HLA) tissue matching or concurrent administration of immunosuppressive medications. With a similar intent, pluripotent stem cell-derived or adult donor-derived human Factor VIII-releasing cells modified with AgeXs UniverCyte will be evaluated in Sernovas hemophilia A program.

Under the terms of the agreement, Sernova has been granted a time-limited, non-exclusive research license by AgeX. A commercial license for Sernova to utilize UniverCyte to engineer cellular products for therapeutic and commercial purposes may be negotiated between the companies pending successful study outcomes.

The UniverCyte technology aims to mask therapeutic cells derived from pluripotent stem cells or adult donors from human immune detection to allow for off-the-shelf cellular products without the need for immunosuppressant medications which may have potent side effects, or HLA-matching between donor and patient. UniverCyte uses a novel, modified form of HLA-G, a potent immunomodulatory molecule, which in nature protects an unborn child from their mothers immune system. In almost all human cells, native HLA-G expression is silenced after birth. AgeXs modified HLA-G shows evidence of being resistant to this silencing, thereby potentially allowing for long-term, stable and high expression of the immunomodulatory effect.

Sernova plans to utilize the universal therapeutic cells generated through this research collaboration with its Cell Pouch System, a proprietary, scalable, implantable macro-encapsulation device, which, upon implantation, incorporates with tissue and forms highly vascularized chambers. These chambers become a natural environment in the body to house and favor long-term survival and function of therapeutic cells. The Cell Pouch System has shown initial safety and efficacy indicators in an ongoing Phase I/II clinical study at the University of Chicago and in a preclinical model of hemophilia A when assessed with human cells corrected to produce Factor VIII.

We are thrilled with our collaboration with Sernova, which is at the forefront of cellular therapies for diabetes and hemophilia and is already in the clinic for the former. The combination of AgeXs UniverCyte to cloak cells from a patients immune system and Sernovas Cell Pouch technologies to permit cells to function long-term upon transplantation would be a landmark for regenerative medicine. This deal marks another important step in AgeXs collaboration and licensing strategy to work with the very best people, companies and institutions in the world of regenerative medicine, said Dr. Nafees Malik, Chief Operating Officer of AgeX.

We look forward to working with AgeX and its outstanding team as we continue to identify and evaluate technologies complementary to Sernovas therapeutic platform and expand our immune protection offerings. AgeXs UniverCyte technology is a significant advancement in the field of cell therapy and a perfect fit with Sernovas Cell Pouch technologies and therapeutic pipeline with its potential benefit over current immunosuppressive strategies for regenerative medicine therapeutics, said Dr. Philip Toleikis, President and CEO of Sernova Corp.

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeXs core product pipeline is intended to extend human healthspan. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.

For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

About Sernova Corp.

Sernova Corp is developing regenerative medicine therapeutic technologies using the Cell Pouch System, a medical device and immune protected therapeutic cells (i.e., human donor cells, corrected human cells and stem-cell-derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. For more information, please visit http://www.sernova.com.

Forward-Looking Statements for AgeX

Certain statements contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the Risk Factors section of AgeXs most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. In addition, there can be no assurance that Sernovas planned use of AgeXs UniverCyteTM gene technology will successfully generate immune-protected universal therapeutic cells for use in combination with Sernovas Cell PouchTM for the treatment of type I diabetes and hemophilia A or any other disease, and there can be no assurance that AgeX and Sernova will enter into a commercial license for the use of UniverCyteTM in a therapeutic or other product. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

Forward-Looking Statements for Sernova

This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words expects, plans, anticipates, believes, intends, estimates, projects, potential and similar expressions, or that events or conditions will, would, may, could or should occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements including those related to the potential of Univercyte combined with Sernovas technologies are not guarantees of future performance, and actual results may differ materially from those in forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Sernovas management on the date such statements were made, which include our beliefs about the effect on company operations of the COVID-19 virus and conduct and outcome of discussions, clinical programs, and our clinical trials. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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AgeX Therapeutics and Sernova to Collaborate to Engineer Universal Locally Immune Protected Cell Therapies for Type I Diabetes and Hemophilia A -...

In Vitro Toxicology Testing Market to Grow at Robust CAGR in the COVID-19 Lockdown Scenario – Cole of Duty

[112 Report Pages] This market research report identifies Laboratory Corporation of America Holdings, Charles River Laboratories, Inc, Thermo Fisher Scientific, Eurofins Scientific, Agilent Technologies, Inc., as the major vendors operating in the global in vitro toxicology testing market. This report also provides a detailed analysis of the market by toxicology end points (systemic toxicity, cytotoxicity testing, genotoxicity testing, ocular toxicity, organ toxicity, dermal toxicity, neurotoxicity, and others), industry type (pharmaceutical and biopharmaceutical, cosmetics, chemical, diagnostics, and food industry), and region (North America, Europe, Asia Pacific, and Rest of the World).

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Infoholicsmarket research report predicts that the globalin vitro toxicology testingmarket will grow at a CAGR of8.2%during the forecast period 20182024.The market for in vitro toxicology testing is driven by high opposition to animal testing, increased cost related to animal-based toxicity testing, and increasing R&D expenditure for early stage toxicity testing. Whereas, the lack of in vitro models and decreased adoption rate are limiting the growth of the in vitro toxicology testingmarket to an extent.

According to the in vitro toxicology testingmarket analysis, Europe accounted for the largest share of the global in vitro toxicology testingmarket followed by North America in 2017. The reason is the upsurge in the investments by the European Commission in R&D to develop substitute methods to in vitro testing is driving the demand in this region. Asia Pacific is expected to grow at a high CAGR during the forecast period due to increasing number of contract research organizations offering testing services, advancements in healthcare infrastructure, increasing investments in the biopharmaceutical sector, and upward economic conditions in the region.

Competitive Analysis and Key Vendors:

There is an increase in collaborations between companies on in vitro testing of compounds. For instance, in December 2016, Evotec and Celgene entered into a drug discovery collaboration for neurodegenerative diseases. According to agreement terms, Celgene will use Evotecs unique induced pluripotent stem cell (iPSC) platform that enables systematic drug screening in patient-derived disease models. In June 2017, Censo Biotechnologies Ltd. collaborated with Evotec AG to source and provide patient-derived induced pluripotent stem cells to support Evotecs drug discovery iPSC platform. In addition, the companies are also coming up with new products for in vitro testing. For instance, in January 2018, STEMCELL Technologies Inc. released two product lines for organoid research that will enable scientists to create powerful models for studying human disease in the laboratory.

Some of the In Vitro Toxicology Testing Market key vendorsare:

Other prominent vendors in the global in vitro toxicology testing market are Bio-Rad Laboratories, GE Healthcare, SGS SA, BioIVT, Abbott Laboratories, Gentronix Limited, Promega Corporation, MB Research Laboratories, Evotec AG (Cyprotex plc), Catalent, Inc., Qiagen N.V., and niche players.

In Vitro Toxicology Testing Market by Toxicology End Points:

In 2017, the systemic toxicity accounted for the highest market share due to the availability of a wide range of sub-studies, which ensure total analysis of toxicity and safety margin of the testing compounds.

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In Vitro Toxicology Testing Market by Industry type:

In 2017, the pharmaceutical and biopharmaceutical industry occupied significant market share and the cosmetics industry is expected to hold a high percentage during the forecast period. Increased support of regulatory authorities to use in vitro and in silico methods instead of animal testing to check toxicology is driving the growth of the cosmetic industry.

In Vitro Toxicology Testing Market Benefits:

The report provides detailed information about the services offered by in vitro toxicology testingin various therapeutic verticals and regions. With that, key stakeholders can find out the major trends, drivers, investments, and vertical players initiatives. Moreover, the report provides details about the major challenges that are going to have an impact on market growth. Additionally, the report gives complete details about the business opportunities to key stakeholders to expand their business and capture revenues in the specific verticals. The report will help companies interested or established in this market to analyze the various aspects of this domain before investing or expanding their business in the in vitro toxicology testingmarket.

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In Vitro Toxicology Testing Market to Grow at Robust CAGR in the COVID-19 Lockdown Scenario - Cole of Duty

Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market In Depth Research with Industry Driving Factors, Consumer Behaviour Analysis,…

Los Angeles, United State: Complete study of the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market is carried out by the analysts in this report, taking into consideration key factors like drivers, challenges, recent trends, opportunities, advancements, and competitive landscape. This report offers a clear understanding of the present as well as future scenario of the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies industry. Research techniques like PESTLE and Porters Five Forces analysis have been deployed by the researchers. They have also provided accurate data on Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies production, capacity, price, cost, margin, and revenue to help the players gain a clear understanding into the overall existing and future market situation.

The research study includes great insights about critical market dynamics, including drivers, restraints, trends, and opportunities. It also includes various types of market analysis such as competitive analysis, manufacturing cost analysis, manufacturing process analysis, price analysis, and analysis of market influence factors. It is a complete study on the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market that can be used as a set of effective guidelines for ensuring strong growth in the coming years. It caters to all types of interested parties, viz. stakeholders, market participants, investors, market researchers, and other individuals associated with the Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies business.

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It is important for every market participant to be familiar with the competitive scenario in the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies industry. In order to fulfil the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.

Key Players Mentioned in the Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Research Report: , Orange County Hair Restoration Center, Hair Sciences Center of Colorado, Anderson Center for Hair, Evolution Hair Loss Institute, Savola Aesthetic Dermatology Center, Virginia Surgical Center, Hair Transplant Institute of Miami, Colorado Surgical Center & Hair Institute Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies

Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Segmentation by Product:, Platelet Rich Plasma Injections, Stem Cell Therapy Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies

Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Segmentation by Application: Dermatology Clinics, Hospitals

The report has classified the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies manufcaturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies industry.

Additionally, the industry analysts have studied key regions including North America, Europe, Asia Pacific, Latin America, and Middle East and Africa, along with their respective countries. Here, they have given a clear-cut understanding of the present and future situations of the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies industry in key regions. This will help the key players to focus on the lucrative regional markets.

Key questions answered in the report:

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Table od Content

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered: Ranking by Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Revenue1.4 Market Analysis by Type1.4.1 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size Growth Rate by Type: 2020 VS 20261.4.2 Platelet Rich Plasma Injections1.4.3 Stem Cell Therapy1.5 Market by Application1.5.1 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Share by Application: 2020 VS 20261.5.2 Dermatology Clinics1.5.3 Hospitals1.6 Coronavirus Disease 2019 (Covid-19): Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Industry Impact1.6.1 How the Covid-19 is Affecting the Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Industry1.6.1.1 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business Impact Assessment Covid-191.6.1.2 Supply Chain Challenges1.6.1.3 COVID-19s Impact On Crude Oil and Refined Products1.6.2 Market Trends and Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Potential Opportunities in the COVID-19 Landscape1.6.3 Measures / Proposal against Covid-191.6.3.1 Government Measures to Combat Covid-19 Impact1.6.3.2 Proposal for Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Players to Combat Covid-19 Impact1.7 Study Objectives1.8 Years Considered 2 Global Growth Trends by Regions2.1 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Perspective (2015-2026)2.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Growth Trends by Regions2.2.1 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Regions: 2015 VS 2020 VS 20262.2.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Historic Market Share by Regions (2015-2020)2.2.3 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Forecasted Market Size by Regions (2021-2026)2.3 Industry Trends and Growth Strategy2.3.1 Market Top Trends2.3.2 Market Drivers2.3.3 Market Challenges2.3.4 Porters Five Forces Analysis2.3.5 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Growth Strategy2.3.6 Primary Interviews with Key Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Players (Opinion Leaders) 3 Competition Landscape by Key Players3.1 Global Top Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Players by Market Size3.1.1 Global Top Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Players by Revenue (2015-2020)3.1.2 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Revenue Market Share by Players (2015-2020)3.1.3 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.2 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Concentration Ratio3.2.1 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Concentration Ratio (CR5 and HHI)3.2.2 Global Top 10 and Top 5 Companies by Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Revenue in 20193.3 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players Head office and Area Served3.4 Key Players Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Product Solution and Service3.5 Date of Enter into Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market3.6 Mergers & Acquisitions, Expansion Plans 4 Breakdown Data by Type (2015-2026)4.1 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Historic Market Size by Type (2015-2020)4.2 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Forecasted Market Size by Type (2021-2026) 5 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Breakdown Data by Application (2015-2026)5.1 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020)5.2 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Forecasted Market Size by Application (2021-2026) 6 North America6.1 North America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020)6.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in North America (2019-2020)6.3 North America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020)6.4 North America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 7 Europe7.1 Europe Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020)7.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in Europe (2019-2020)7.3 Europe Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020)7.4 Europe Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 8 China8.1 China Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020)8.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in China (2019-2020)8.3 China Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020)8.4 China Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 9 Japan9.1 Japan Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020)9.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in Japan (2019-2020)9.3 Japan Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020)9.4 Japan Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 10 Southeast Asia10.1 Southeast Asia Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020)10.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in Southeast Asia (2019-2020)10.3 Southeast Asia Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020)10.4 Southeast Asia Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 11 India11.1 India Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020)11.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in India (2019-2020)11.3 India Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020)11.4 India Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 12 Central & South America12.1 Central & South America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020)12.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in Central & South America (2019-2020)12.3 Central & South America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020)12.4 Central & South America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 13 Key Players Profiles13.1 Orange County Hair Restoration Center13.1.1 Orange County Hair Restoration Center Company Details13.1.2 Orange County Hair Restoration Center Business Overview and Its Total Revenue13.1.3 Orange County Hair Restoration Center Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction13.1.4 Orange County Hair Restoration Center Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020))13.1.5 Orange County Hair Restoration Center Recent Development13.2 Hair Sciences Center of Colorado13.2.1 Hair Sciences Center of Colorado Company Details13.2.2 Hair Sciences Center of Colorado Business Overview and Its Total Revenue13.2.3 Hair Sciences Center of Colorado Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction13.2.4 Hair Sciences Center of Colorado Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020)13.2.5 Hair Sciences Center of Colorado Recent Development13.3 Anderson Center for Hair13.3.1 Anderson Center for Hair Company Details13.3.2 Anderson Center for Hair Business Overview and Its Total Revenue13.3.3 Anderson Center for Hair Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction13.3.4 Anderson Center for Hair Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020)13.3.5 Anderson Center for Hair Recent Development13.4 Evolution Hair Loss Institute13.4.1 Evolution Hair Loss Institute Company Details13.4.2 Evolution Hair Loss Institute Business Overview and Its Total Revenue13.4.3 Evolution Hair Loss Institute Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction13.4.4 Evolution Hair Loss Institute Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020)13.4.5 Evolution Hair Loss Institute Recent Development13.5 Savola Aesthetic Dermatology Center13.5.1 Savola Aesthetic Dermatology Center Company Details13.5.2 Savola Aesthetic Dermatology Center Business Overview and Its Total Revenue13.5.3 Savola Aesthetic Dermatology Center Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction13.5.4 Savola Aesthetic Dermatology Center Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020)13.5.5 Savola Aesthetic Dermatology Center Recent Development13.6 Virginia Surgical Center13.6.1 Virginia Surgical Center Company Details13.6.2 Virginia Surgical Center Business Overview and Its Total Revenue13.6.3 Virginia Surgical Center Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction13.6.4 Virginia Surgical Center Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020)13.6.5 Virginia Surgical Center Recent Development13.7 Hair Transplant Institute of Miami13.7.1 Hair Transplant Institute of Miami Company Details13.7.2 Hair Transplant Institute of Miami Business Overview and Its Total Revenue13.7.3 Hair Transplant Institute of Miami Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction13.7.4 Hair Transplant Institute of Miami Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020)13.7.5 Hair Transplant Institute of Miami Recent Development13.8 Colorado Surgical Center & Hair Institute13.8.1 Colorado Surgical Center & Hair Institute Company Details13.8.2 Colorado Surgical Center & Hair Institute Business Overview and Its Total Revenue13.8.3 Colorado Surgical Center & Hair Institute Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction13.8.4 Colorado Surgical Center & Hair Institute Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020)13.8.5 Colorado Surgical Center & Hair Institute Recent Development 14 Analysts Viewpoints/Conclusions 15 Appendix15.1 Research Methodology15.1.1 Methodology/Research Approach15.1.2 Data Source15.2 Disclaimer15.3 Author Details

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Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market In Depth Research with Industry Driving Factors, Consumer Behaviour Analysis,...

COVID-19 Impact on JOINT PAIN INJECTION MARKET CURRENT INDUSTRY STATUS, GROWTH OPPORTUNITIES, TOP KEY PLAYERS, TARGET AUDIENCE AND FORECAST 2020 TO…

Global Joint Pain Injection Market Analysis to 2027 is a specialized and in-depth study of the pharmaceutical with a special focus on the global market trend analysis. The report aims to provide an overview of joint pain injection market with detailed market segmentation by injection, joint type, distribution channel and geography. The global joint pain injection market is expected to witness high growth during the forecast period. The report provides key statistics on the market status of the leading Joint pain injection market players and offers key trends and opportunities in the market.

Joint pain injections are medicinal fluids inserted in the body of patients to get faster relief from severe pain. The joint pain injections are used to reduce inflammation in the joints. There are several types of injections available in the market which are corticosteroids injections, hyaluronic acid (HA) injections, platelet-rich plasma (PRP) injections and placental tissue matrix (PTM) injections.

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MARKET DYNAMICS:

The joint pain injection market is anticipated to grow in the forecast, owing to increasing prevalence of the osteoporosis, rise in the elderly population, increasing prevalence of the rheumatoid arthritis and others. The advancement in the field of pharmaceutical and orthobiologics are likely to create growth opportunities for the joint pain injection market.

MARKET PLAYERS

In addition, the report focuses on leading industry players with information such as company profiles, components and services offered, financial information of last 3 years, key development in past five years.

The report also includes the profiles of key joint pain injection market companies along with their SWOT analysis and market strategies.The Insight Partners dedicated research and analysis team consist of experienced professionals with advanced statistical expertise and offer various customization options in the existing study.

MARKET SEGMENTATIONThe global joint pain injection market is segmented on the basis of injection, joint type and distribution channel. Based on the injection segment the market is classified as hyaluronic acid injections, corticosteroid injections and others. On the basis of joint type the market is segmented as knee, foot and ankle, shoulder and elbow, hip and others. Based on distribution channel the market is classified as retail pharmacies, hospitals pharmacies and others.

REGIONAL FRAMEWORK

The report provides a detailed overview of the industry including both qualitative and quantitative information. It provides overview and forecast of the global Joint pain injection market based on various segments. It also provides market size and forecast estimates from year 2017 to 2027 with respect to five major regions, namely; North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South & Central America. The joint pain injection market by each region is later sub-segmented by respective countries and segments. The report covers analysis and forecast of 18 countries globally along with current trend and opportunities prevailing in the region.

The report analyzes factors affecting joint pain injection market from both demand and supply side and further evaluates market dynamics effecting the market during the forecast period i.e., drivers, restraints, opportunities, and future trend. The report also provides exhaustive PEST analysis for all five regions namely; North America, Europe, APAC, MEA and South & Central America after evaluating political, economic, social and technological factors effecting the joint pain injection market in these regions.

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COVID-19 Impact on JOINT PAIN INJECTION MARKET CURRENT INDUSTRY STATUS, GROWTH OPPORTUNITIES, TOP KEY PLAYERS, TARGET AUDIENCE AND FORECAST 2020 TO...

Stem cell therapy: a potential approach for treatment of influenza virus and coronavirus-induced acute lung injury – BMC Blogs Network

Acute lung injury (ALI) is a devastating disease process involving pulmonary edema and atelectasis caused by capillary membrane injury [1]. The main clinical manifestation is the acute onset of hypoxic respiratory failure, which can subsequently trigger a cascade of serious complications and even death [2]. Thus, ALI causes a considerable financial burden for health care systems throughout the world. ALI can result from various causes, including multiple traumas, large-volume blood transfusions, and bacterial and viral infections [2, 3]. A variety of viruses, including influenza virus, coronavirus (CoV), adenovirus, cytomegalovirus (CMV), and respiratory syncytial virus (RSV), are associated with ALI [4]. Importantly, most viruses, whose hosts are various animal species, can cause severe and rapidly spreading human infections. In the early 2000s, several outbreaks of influenza virus and CoV emerged, causing human respiratory and intestinal diseases worldwide, including the more recent SARS-CoV-2 infection [5,6,7]. To date, SARS-CoV-2 has affected more than 80,000 people, causing nearly 3300 deaths in China and more than 1,800,000 people, causing nearly 110,000 deaths all over the world (http://2019ncov.chinacdc.cn/2019-nCoV/).

Infectious respiratory diseases caused by different viruses are associated with similar respiratory symptoms ranging from the common cold to severe acute respiratory syndrome [8]. This makes the clinical distinction between different agents involved in infection very difficult [8, 9]. Currently, the clinical experience mainly includes antibacterial and antiviral drug treatment derived from handling several outbreaks of influenza virus and human CoVs. Numerous agents have been identified to inhibit the entry and/or replication of these viruses in cell culture or animal models [10]. Although these antiviral drugs can effectively prevent and eliminate the virus, the full recovery from pneumonia and ALI depends on the resistance of the patient. Recently, stem cell-based therapy has become a potential approved tool for the treatment of virus-induced lung injury [11,12,13]. Here, we will give a brief overview of influenza virus and CoVs and then present the cell-based therapeutic options for lung injury caused by different kinds of viruses.

Influenza virus and human CoV are the two most threatening viruses for infectious lung injury [14]. These pathogens can be transmitted through direct or indirect physical contact, droplets, or aerosols, with increasing evidence suggesting that airborne transmission, including via droplets or aerosols, enhances the efficiency of viral transmission among humans and causes uncontrolled infectious disease [15]. Throughout human history, outbreaks and occasional pandemics caused by influenza virus and CoV have led to approximately hundreds of millions of deaths worldwide [16].

Influenza virus is a well-known human pathogen that has a negative-sense RNA genome [17]. According to its distinct antigenic properties, the influenza virus can be divided into 4 subtypes, types A, B, C, and D. Influenza A virus (IAV) lineages in animal populations cause economically important respiratory disease. Little is known about the other human influenza virus types B, C, and D [18]. Further subtypes are characterized by the genetic and antigenic properties of the hemagglutinin (HA) and neuraminidase (NA) glycoproteins [19]. Sporadic and seasonal infections in swine with avian influenza viruses of various subtypes have been reported. The most recent human pandemic virusesH1N1 from swine and H5N1 from aviancause severe respiratory tract disease and lung injury in humans [20, 21].

CoVs, a large family of single-stranded RNA viruses, typically affect the respiratory tract of mammals, including humans. CoVs are further divided into four genera: alpha-, beta-, gamma-, and delta-CoVs. Alpha- and beta-CoVs can infect mammals, and gamma- and delta-CoVs tend to infect birds, but some of these viruses can also be transmitted to mammals [22]. Human CoVs were considered relatively harmless respiratory pathogens in the past. Infections with the human CoV strains 229E, OC43, NL63, and HKU1 usually result in mild respiratory illness, such as the common cold [23]. In contrast, the CoV responsible for the 2002 severe acute respiratory syndrome (SARS-CoV), the 2012 Middle East respiratory syndrome CoV (MERS-CoV), and, more recently, the SARS-CoV-2 have received global attention owing to their genetic variation and rapid spread in human populations [5,6,7].

Usually, the influenza virus can enter the columnar epithelial cells of the respiratory tract, such as the trachea, bronchi, and bronchioles. Subsequently, the influenza virus begins to replicate for an asymptomatic period of time and then migrate to the lung tissue to cause acute lung and respiratory injury [24]. Similar to those with influenza virus infection, patients with SARS, MERS, or SARS-CoV-2 present with various clinical features, ranging from asymptomatic or mild respiratory illness to severe ALI, even with multiple organ failure [5,6,7]. The pathogenesis of ALI caused by influenza virus and human CoV is often associated with rapid viral replication, marked inflammatory cell infiltration, and elevated proinflammatory cytokine/chemokine responses [25]. Interestingly, in IAV- and human CoV-infected individuals, the pulmonary pathology always involves diffuse alveolar damage, but viral RNA is present in only a subset of patients [26]. Some studies suggest that an overly exaggerated immune response, rather than uncontrolled viral spread, is the primary cause in fatal cases caused by virus infection [27]. Several immune cell types have been found to contribute to damaging host responses, providing novel approaches for therapeutic intervention [28].

IAV infection, the most common cause of viral pneumonia, causes substantial seasonal and pandemic morbidity and mortality [29]. Currently, antiviral drugs are the primary treatment strategy for influenza-induced pneumonia. However, antiviral drugs cannot repair damaged lung cells. Here, we summarize the present studies of stem cell therapy for influenza virus-induced lung injury.

Mesenchymal stem/stromal cells (MSCs) constitute a heterogeneous subset of stromal regenerative cells that can be harvested from several adult tissue types, including bone marrow, umbilical cord, adipose, and endometrium [30]. They retain the expression of the markers CD29, CD73, CD90, and CD105 and have a rapid proliferation rate, low immunogenicity, and low tumorigenicity [30]. MSCs also have self-renewal and multidifferentiation capabilities and exert immunomodulatory and tissue repair effects by secreting trophic factors, cytokines, and chemokines [31]. Due to these beneficial biological properties, MSCs and their derivatives are attractive as cellular therapies for various inflammatory diseases, including virus-induced lung injury.

Several studies on IAV-infected animal models have shown the beneficial effects of the administration of different tissue-derived MSCs [32,33,34,35]. H5N1 virus infection reduces alveolar fluid clearance (AFC) and enhances alveolar protein permeability (APP) in human alveolar epithelial cells, which can be inhibited by coculture with human bone marrow-derived MSCs (BMSCs) [32]. Mechanistically, this process can be mediated by human BMSC secreted angiopoietin-1 (Ang1) and keratinocyte growth factor (KGF) [32]. Moreover, in vivo experiments have shown that human BMSCs have a significant anti-inflammatory effect by increasing the number of M2 macrophages and releasing various cytokines and chemokines, such as interleukin (IL)-1, IL-4, IL-6, IL-8, and IL-17 [32]. Similar anti-inflammatory effects have been achieved in another virus-induced lung injury model. The intravenous injection of mouse BMSCs into H9N2 virus-infected mice significantly attenuates H9N2 virus-induced pulmonary inflammation by reducing chemokine (GM-CSF, MCP-1, KC, MIP-1, and MIG) and proinflammatory cytokine (IL-1, IL-6, TNF-, and IFN-) levels, as well as reducing inflammatory cell recruitment into the lungs [33]. Another study on human BMSCs cocultured with CD8+ T cells showed that MSCs inhibit the proliferation of virus-specific CD8+ T cells and the release of IFN- by specific CD8+ T cells [36].

In addition, human umbilical cord-derived MSCs (UC-MSCs) were found to have a similar effect as BMSCs on AFC, APP, and inflammation by secreting growth factors, including Ang1 and hepatocyte growth factor (HGF), in an in vitro lung injury model induced by H5N1 virus [34]. UC-MSCs also promote lung injury mouse survival, increase the body weight, and decreased the APP levels and inflammation in vivo [34]. Unlike Ang1, KGF, and HGF mentioned above, basic fibroblast growth factor 2 (FGF2) plays an important role in lung injury therapy via immunoregulation. The administration of the recombinant FGF2 protein improves H1N1-induced mouse lung injury and promotes the survival of infected mice by recruiting and activating neutrophils via the FGFR2-PI3K-AKT-NFB signaling pathway [37]. FGF2-overexpressing MSCs have an enhanced therapeutic effect on lipopolysaccharide-induced ALI, as assessed by the proinflammatory factor level, neutrophil quantity, and histopathological index of the lung [38].

MSCs secrete various soluble factors and extracellular vesicles (EVs), which carry lipids, proteins, DNA, mRNA, microRNAs, small RNAs, and organelles. These biologically active components can be transferred to recipient cells to exert anti-inflammatory, antiapoptotic, and tissue regeneration functions [39]. EVs isolated from conditioned medium of pig BMSCs have been demonstrated to have anti-apoptosis, anti-inflammation, and antiviral replication functions in H1N1-affected lung epithelial cells and alleviate H1N1-induced lung injury in pigs [35]. Moreover, the preincubation of EVs with RNase abrogates their anti-influenza activity, suggesting that the anti-influenza activity of EVs is due to the transfer of RNAs from EVs to epithelial cells [35]. Exosomes are a subset of EVs that are 50200nm in diameter and positive for CD63 and CD81 [40]. Exosomes isolated from the conditioned medium of UC-MSCs restore the impaired AFC and decreased APP in alveolar epithelial cells affected by H5N1 virus [34]. In addition, the ability of UC-MSCs to increase AFC is superior to that of exosomes, which indicates that other components secreted by UC-MSCs have synergistic effects with exosomes [34].

Despite accumulating evidence demonstrating the therapeutic effects of MSC administration in various preclinical models of lung injury, some studies have shown contrasting results. Darwish and colleagues proved that neither the prophylactic nor therapeutic administration of murine or human BMSCs could decrease pulmonary inflammation or prevent the progression of ALI in H1N1 virus-infected mice [41]. In addition, combining MSC administration with the antiviral agent oseltamivir was also found to be ineffective [41]. Similar negative results were obtained in another preclinical study. Murine or human BMSCs were administered intravenously to H1N1-induced ARDS mice [42]. Although murine BMSCs prevented influenza-induced thrombocytosis and caused a modest reduction in lung viral load, murine or human BMSCs failed to improve influenza-mediated lung injury as assessed by weight loss, the lung water content, and bronchoalveolar lavage inflammation and histology, which is consistent with Darwishs findings [42]. However, the mild reduction in viral load observed in response to murine BMSC treatment suggests that, on balance, MSCs are mildly immunostimulatory in this model [42]. Although there are some controversial incidents in preclinical research, the transplant of menstrual-blood-derived MSCs into patients with H7N9-induced ARDS was conducted at a single center through an open-label clinical trial (http://www.chictr.org.cn/). MSC transplantation significantly lowered the mortality and did not result in harmful effects in the bodies of the patients [43]. This clinic study suggests that MSCs significantly improve the survival rate of influenza virus-induced lung injury.

The effects of exogenous MSCs are exerted through their isolation and injection into test animals. There are also some stem/progenitor cells that can be activated to proliferate when various tissues are injured. Basal cells (BCs), distributed throughout the pseudostratified epithelium from the trachea to the bronchioles, are a class of multipotent tissue-specific stem cells from various organs, including the skin, esophagus, and olfactory and airway epithelia [44, 45]. Previously, TPR63+/KRT5+ BCs were shown to self-renew and divide into club cells and ciliated cells to maintain the pseudostratified epithelium of proximal airways [46]. Several studies have shown that TPR63+/KRT5+ BCs play a key role in lung repair and regeneration after influenza virus infection. When animals typically recover from H1N1 influenza infection, TPR63+/KRT5+ BCs accumulate robustly in the lung parenchyma and initiate an injury repair process to maintain normal lung function by differentiating into mature epithelium [47]. Lineage-negative epithelial stem/progenitor (LNEP) cells, present in the normal distal lung, can activate a TPR63+/KRT5+ remodeling program through Notch signaling after H1N1 influenza infection [48]. Moreover, a population of SOX2+/SCGB1A/KRT5 progenitor cells can generate nascent KRT5+ cells as an early response to airway injury upon H1N1 influenza virus infection [49]. In addition, a rare p63+Krt5 progenitor cell population also responds to H1N1 virus-induced severe injury [50]. This evidence suggests that these endogenous lung stem/progenitor cells (LSCs) play a critical role in the repopulation of damaged lung tissue following severe influenza virus infection (Table2).

Taken together, the present in vitro (Table1) and in vivo (Table2) results show that MSCs and LSCs are potential cell sources to treat influenza virus-induced lung injury.

Lung injury caused by SARS, MERS, or SARS-CoV-2 poses major clinical management challenges because there is no specific treatment that has been proven to be effective for each infection. Currently, virus- and host-based therapies are the main methods of treatment for spreading CoV infections. Virus- and host-based therapies include monoclonal antibodies and antiviral drugs that target the key proteins and pathways that mediate viral entry and replication [51].The major challenges in the clinical development of novel drugs include a limited number of suitable animal models for SARS-CoV, MERS-CoV, and SARS-CoV-2 infections and the current absence of new SARS and MERS cases [51]. Although the number of cases of SARS-CoV-2-induced pneumonia patients is continuously increasing, antibiotic and antiviral drugs are the primary methods to treat SARS-CoV-2-infected patients. Similar to that of IAV, human CoV-mediated damage to the respiratory epithelium results from both intrinsic viral pathogenicity and a robust host immune response. The excessive immune response contributes to viral clearance and can also worsen the severity of lung injury, including the demise of lung cells [52]. However, the present treatment approaches have a limited effect on lung inflammation and regeneration.

Stem cell therapy for influenza virus-induced lung injury shows promise in preclinical models. Although it is difficult to establish preclinical models of CoV-induced lung injury, we consider stem cell therapies to be effective approaches to improve human CoV-induced lung injury. Acute inflammatory responses are one of the major underlying mechanisms for virus-induced lung injury. Innate immune cells, including neutrophils and inflammatory monocytes-macrophages (IMMs), are major innate leukocyte subsets that protect against viral lung infections [53]. Both neutrophils and IMMs are rapidly recruited to the site of infection and play crucial roles in the host defense against viruses. Neutrophils and IMMs can activate Toll-like receptors (TLRs) and produce interferons (IFNs) and other cytokines/chemokines [54]. There are two functional effects produced by the recruitment of neutrophils and IMMs: the orchestration of effective adaptive T cell responses and the secretion of inflammatory cytokines/chemokines [55]. However, excessive inflammatory cytokine and chemokine secretion impairs antiviral T cell responses, leading to ineffective viral clearance and reduced survival [56].

MSCs are known to suppress both innate and adaptive immune responses. MSCs have been suggested to inhibit many kinds of immune cells, including T cells, B cells, dendritic cells (DCs), and natural killer (NK) cells in vitro and in vivo [57] (Fig.1). Several molecules, including IL-1, TNF-, and INF-, most of which are produced by inflammatory cells, are reported to be involved in MSC-mediated immunosuppression [58]. Furthermore, MSCs can produce numerous immunosuppressive molecules, such as IL-6, PGE2, IDO, and IL-10, in response to inflammatory stimuli. PGE2 has been reported to mediate the MSC-mediated suppression of T cells, NK cells, and macrophages. Moreover, PGE2 has been found to act with IDO to alter the proliferation of T cells and NK cells [59]. In contrast, MSCs have come to be recognized as one type of adult stem cell actively participating in tissue repair by closely interacting with inflammatory cells and various other cell types [60]. Numerous reports have demonstrated that MSCs can release an array of growth and inhibitory factors, such as EGF, FGF, PDGF, and VEGF, and express several leukocyte chemokines, such as CXCL9, CCL2, CXCL10, and CXCL11. These factors provide an important microenvironment to activate adaptive immunity for lung repair [61]. Thus, the dual functions of MSCs may improve lung recovery after human CoV-induced ALI. Recently, MSCs was transplanted intravenously to enrolled patients with COVID-19 pneumonia. After treatment, the pulmonary function and symptoms of these patients were significantly improved. Meanwhile, the peripheral lymphocytes were increased, the C-reactive protein decreased, the level of TNF- was significantly decreased, and the overactivated cytokine-secreting immune cells disappeared. In addition, a group of regulatory DC cell population dramatically increased. Thus, the intravenous transplantation of MSCs was effective for treatment in patients with COVID-19 pneumonia [62, 63].

Stem cell therapies for treatment of influenza virus and coronavirus-induced lung injury. CoVs, coronavirus; MSCs, mesenchymal stem/stromal cells; LSCs, lung stem/progenitor cells; NK cells, natural killer cells; DC cells, dendritic cells

In addition, endogenous LSCs also play an important role in lung cell reconstitution after virus-induced ALI. In particular, TPR63+/KRT5+ airway BCs comprise approximately equal numbers of stem cells and committed precursors and give rise to differentiated luminal cells during steady state and epithelial repair after lung injury [44, 64]. Research has shown that KRT5+ cells repopulate damaged alveolar parenchyma following influenza virus infection [47]. However, there is still little evidence for the role of altered TPR63+/KRT5+ stem cells during lung injury repair caused by human CoVs.

In summary, exogenous MSCs may modulate human CoV-induced lung injury repair and regeneration through their immunoregulatory properties. These cells are capable of interacting with various types of immune cell, including neutrophils, macrophages, T cells, B cells, NK cells, and DCs. Furthermore, viral infections can activate endogenous LSCs to produce new lung cells and maintain lung function (Fig.1). Thus, we propose that MSCs and LSCs are two potential cell sources for treating human CoV-induced lung injury.

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Stem cell therapy: a potential approach for treatment of influenza virus and coronavirus-induced acute lung injury - BMC Blogs Network

Startup targets glioblastoma tumors with CAR-T therapy – FierceBiotech

One of the major breakthroughs in cancer treatment is CAR-T technology, which involves genetically modifyinga patients own immune cells so they can recognize and attack cancer. But while the innovationhas benefited patients with certain blood malignancies, progress in solid tumors remains limited.

Now, scientists at McMaster University and the University of Toronto have developed a CAR-T therapy for the aggressive brain cancer glioblastoma. It helped reduce tumor burden and improved survival in mouse models, according to a new study published in the journal Cell Stem Cell.

The researchers were so encouraged by the findings that they launched a startup called Empirica Therapeutics, which aims to bring the CAR-T drug into clinical trials in recurrent glioblastoma patients by 2022.

For each CAR-T construct, T cells are modified to produce a special structure called a chimeric antigen receptor (CAR) that gives the cells the ability to recognize a specific protein on cancer cells. The two FDA-approved CAR-Ts, Novartis Kymriah and Gilead Sciences Yescarta, are directed toward CD19. TheCAR-T cell Empirica is developing targets CD133, also known as prominin-1.

In a 2003 Cancer Research study, a McMaster University team identified a group of neural stem cells from human brain tumors that bear CD133 on their surface. They found these CD133-expressing cells could differentiate into cells identical to the original tumor, suggesting these stem cells are necessary for glioblastoma tumor growth.

For the current study, the team tested three types of treatments in lab dishes and in mice. The first was a human IgG antibody that binds to CD133 on glioblastoma cells. The second was a bispecific T-cell engager antibody (BiTE), which can recruit cytotoxic T cells to kill tumor cells. The third was the CAR-T, known at Empirica as eCAR-133.

We found that the CAR-T therapy had enhanced activity compared to the other two therapeutics in preclinical models of human glioblastoma, Parvez Vora, the studys first author and director of preclinical development at Empirica, said in a statement.

Moreover, the CAR-T drug didnt induce any acute systemic toxicity in mice, showing it wouldnt disrupt hematopoiesis, a vital process in the human body that leads to the formation of blood cells, Vora said.

RELATED:Killing brain tumors with CAR-Ts built with scorpion venom

The potent clinical responses from CAR-T cells in blood cancers have sparked interest in exploring the approach in solid tumors, including hard-to-treat glioblastoma. A research team at City of Hope recently designed a novel CAR based on chlorotoxin, a toxin found in scorpion venom, and recorded promising results of the CAR-T cells in mice with glioblastoma xenografts.

There are many obstacles ahead. For one thing, the glioblastoma tumor microenvironment is notoriously immunosuppressive, which could dampen CAR-T cells activity once they arrive at the tumor site.

Besides CD133, other glioblastoma CAR-T targets that have been floated include IL-13Ra2 from City of Hope researchers, CSPG4froma team at the University of North Carolina, NKG2DL and EGFRvIII, among others.One possibility could be a combo of CAR-T and BiTEtechnologies. Last year, a team led by Massachusetts General Hospital designeda CAR-T that also expressed BiTE to activate bystander T cells against tumors. The CAR-T/BiTE cells eliminated tumors in mouse models of glioblastoma.

The Empirica scientists are also exploring combination strategies for their CD133-targeting CAR-T to treat glioblastoma."We hope that our work will now advance the development of really new and promising treatment options for these patients," said co-author Sheila Singh, professor in the department of surgery at McMaster and CEO of the startup.

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Startup targets glioblastoma tumors with CAR-T therapy - FierceBiotech

Coronavirus (COVID-19) Business Impact Stem Cell Therapy Market Size Analysis 2019-2027 – Cole of Duty

Analysis of the Global Stem Cell Therapy Market

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According to the analysts at Stem Cell Therapy , the Stem Cell Therapy market is predicted to register a CAGR growth of ~XX% during the assessment and reach a value of ~US$ XX by the end of 20XX. The report analyzes the micro and macro-economic factors that are projected to influence the growth of the Stem Cell Therapy market in the coming decade.

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Segmentation of the Stem Cell Therapy Market

The presented report elaborate on the Stem Cell Therapy market into different segments and ponders over the current and future business potentials of each segment. The report showcases the year-on-year growth of each segment and ponders upon the different factors that are likely to influence the growth of each market segment.

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Competition AnalysisIn the competitive analysis section of the report, leading as well as prominent players of the global Stem Cell Therapy market are broadly studied on the basis of key factors. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on price and revenue (global level) by player for the period 2015-2020.On the whole, the report proves to be an effective tool that players can use to gain a competitive edge over their competitors and ensure lasting success in the global Stem Cell Therapy market. All of the findings, data, and information provided in the report are validated and revalidated with the help of trustworthy sources. The analysts who have authored the report took a unique and industry-best research and analysis approach for an in-depth study of the global Stem Cell Therapy market.The following players are covered in this report:Osiris TherapeuticsNuVasiveChiesi PharmaceuticalsJCR PharmaceuticalPharmicellMedi-postAnterogenMolmedTakeda (TiGenix)Stem Cell Therapy Breakdown Data by TypeAutologousAllogeneicStem Cell Therapy Breakdown Data by ApplicationMusculoskeletal DisorderWounds & InjuriesCorneaCardiovascular DiseasesOthers

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Coronavirus (COVID-19) Business Impact Stem Cell Therapy Market Size Analysis 2019-2027 - Cole of Duty

COVID-19: Responding to the business impacts of Allogeneic Stem Cell Therapy Revenue, Opportunity, Forecast and Value Chain 2019-2020 – Cole of Duty

Allogeneic Stem Cell Therapy Market 2018: Global Industry Insights by Global Players, Regional Segmentation, Growth, Applications, Major Drivers, Value and Foreseen till 2024

The report provides both quantitative and qualitative information of global Allogeneic Stem Cell Therapy market for period of 2018 to 2025. As per the analysis provided in the report, the global market of Allogeneic Stem Cell Therapy is estimated to growth at a CAGR of _% during the forecast period 2018 to 2025 and is expected to rise to USD _ million/billion by the end of year 2025. In the year 2016, the global Allogeneic Stem Cell Therapy market was valued at USD _ million/billion.

This research report based on Allogeneic Stem Cell Therapy market and available with Market Study Report includes latest and upcoming industry trends in addition to the global spectrum of the Allogeneic Stem Cell Therapy market that includes numerous regions. Likewise, the report also expands on intricate details pertaining to contributions by key players, demand and supply analysis as well as market share growth of the Allogeneic Stem Cell Therapy industry.

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Allogeneic Stem Cell Therapy Market Overview:

The Research projects that the Allogeneic Stem Cell Therapy market size will grow from in 2018 to by 2024, at an estimated CAGR of XX%. The base year considered for the study is 2018, and the market size is projected from 2018 to 2024.

The report on the Allogeneic Stem Cell Therapy market provides a birds eye view of the current proceeding within the Allogeneic Stem Cell Therapy market. Further, the report also takes into account the impact of the novel COVID-19 pandemic on the Allogeneic Stem Cell Therapy market and offers a clear assessment of the projected market fluctuations during the forecast period. The different factors that are likely to impact the overall dynamics of the Allogeneic Stem Cell Therapy market over the forecast period (2019-2029) including the current trends, growth opportunities, restraining factors, and more are discussed in detail in the market study.

Leading manufacturers of Allogeneic Stem Cell Therapy Market:

The key players covered in this studyEscape Therapeutics, Inc.Lonza Group Ltd.Osiris Therapeutics (Smith & Nephew)NuVasiveChiesi PharmaceuticalsJCR PharmaceuticalPharmicellAnterogenMolMed S.p.A.Takeda (TiGenix)

Market segment by Type, the product can be split intoAdult Stem Cell TherapyHuman Embryonic Stem Cell TherapyInduced Pluripotent Stem Cell TherapyOthersMarket segment by Application, split intoMusculoskeletal DisorderWounds & InjuriesCardiovascular DiseasesOthers

Market segment by Regions/Countries, this report coversNorth AmericaEuropeChinaJapanSouth Korea

The study objectives of this report are:To analyze global Allogeneic Stem Cell Therapy status, future forecast, growth opportunity, key market and key players.To present the Allogeneic Stem Cell Therapy development in North America, Europe, China, Japan and South Korea.To strategically profile the key players and comprehensively analyze their development plan and strategies.To define, describe and forecast the market by type, market and key regions.

In this study, the years considered to estimate the market size of Allogeneic Stem Cell Therapy are as follows:History Year: 2015-2019Base Year: 2019Estimated Year: 2020Forecast Year 2020 to 2026For the data information by region, company, type and application, 2019 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

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And Many More.

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COVID-19: Responding to the business impacts of Allogeneic Stem Cell Therapy Revenue, Opportunity, Forecast and Value Chain 2019-2020 - Cole of Duty