Stem Cell Clinic

Induced Pluripotent Stem Cells Market to Grow with an Impressive CAGR – Farming Sector

The global market for induced pluripotent stem cells (iPSCs) reached $2.1 billion in 2016. The market should reach $3.6 billion in 2021, increasing at a compound annual growth rate (CAGR) of 11.6% from 2016 through 2021.

Report Scope:

This study is focused on the market side of iPSCs rather than its technical side. Different market segments for this emerging market are covered. For example, application-based market segments include academic research, drug development and toxicity testing, and regenerative medicine; product function-based market segments include molecular and cellular engineering, cellular reprogramming, cell culture, cell differentiation and cell analysis; iPSC-derived cell-type-based market segments include cardiomyocytes, hepatocytes, neurons, endothelia cells and other cell types; geography-based market segments include the U.S., Europe, Asia-Pacific and Rest of World. Research and market trends are also analyzed by studying the funding, patent publications and research publications in the field.

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Report Includes:

An overview of the global market for induced pluripotent stem cells. Analyses of global market trends with data from 2015 and 2016, and projections of compound annual growth rates (CAGRs) through 2021. Information on induced pluripotent stem cell research products, defined as all research tools including but not limited to: induced pluripotent stem cells and various differentiated cells derived from induced pluripotent stem cells; various related assays and kits, culture media and medium components, such as serum, growth factors and inhibitors, antibodies, enzymes, and many others that can be applied for the specific purpose of executing induced pluripotent stem cell research. Discussion of important manufacturers, technologies, and factors influencing market demand, such as the driving forces and limiting factors of induced pluripotent stem cell market growth. Profiles of major players in the industry.

Report Summary

Its been over 10 years since the discovery of induced pluripotent stem cell (iPSC) technology. The market has gradually become an important part of the life sciences industry during recent years. Particularly for the past five years, the global market for iPSCs has experienced a rapid growth. The market was estimated at $1.7 billion in 2015 and over $2 billion in 2016, with an average 18% growth. The overall iPSC market is forecast to continue its relatively rapid growth and reach over $3.6 billion in 2021, with an estimated compound annual growth rate (CAGR) of 11.6% from 2016 through 2021.

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Key Drivers for Market Growth

This report has identified several key drivers for the rapidly growing market: iPSC shold promising hope for therapeutic solutions for diseases without ethical issues. A series of technical breakthroughs were made in recent years for improving cellular reprogramming, differentiation and large-scale production of GMP- grade iPSCs derived cells toward clinical usability. The pharmaceutical industry needs better cell sources such as iPSC-derived functional cells for drug toxicity testing and drug screening. The U.S. government has been encouraging the marketing of stem cells, including iPSCs. The U.S. Food and Drug Administration (FDA) has been authorized to provide orphan drug designations for many of the therapies developed for rare diseases such as Parkinsons and Huntingtons using stem cells. The provisions of grants from organizations, such as the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) have been encouraging for the research institutes to venture into iPSC research. Rapidly growing medical tourism and contract research outsourcing drives the Asia-Pacific stem cell market. Cellular reprogramming, including iPSC technology, was awarded the 2012 Nobel Prize. The first human iPSC clinical trial started in August 2014, and the recent report of the first macular degeneration patient treated with the sheets of retinal pigmented epithelial cells made from iPSCs was encouraging. iPSC technology is developing into a platform for precision and personalized medicine, which is experiencing rapid growth globally. New biotechnologies such as genome editing technology are advancing iPSCs into more and better uses.

This report identifies key revenue segments for the iPSC market from various aspects. The applicationbased segments include the research, drug development and clinical markets; the product functionbased segments include molecular and cellular engineering, cellular reprogramming, cell culture, cell differentiation and cell analysis. The current major revenue segment is the drug development and toxicity testing sector, but the market for regenerative medicine is the fastest growing one. The market for clinical applications is not fully established, but the market for the translational medicine research of iPSC is also growing very quickly.

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Induced Pluripotent Stem Cells Market to Grow with an Impressive CAGR - Farming Sector

Accelerating cell-based therapies by providing safe therapeutic MSC products – BioSpace

TORONTO, Jan. 8, 2021 /CNW/ -panCELLa's intent to develop therapeutic products in the mesenchymal stem cell (MSC) and pancreatic islet space has recently led to the creation of Implant Therapeutics.

Implant Therapeutics, under the guidance of Dr. Mahendra Rao, is engineering iPSC-MSC cells containing panCELLa's FailSafe and induced Allogeneic Cell Tolerance (iACT Stealth Cell) technologies. These iPSC MSC cells are hypo-immunogenic and are an ideal choice for bone, cartilage and tendon replacement strategies combining the advantages of allogeneic and autologous cells as well as allowing them to be used as ex-vivo gene therapy vehicles.

Implant is pleased to announce a definitive cross licensing agreement with RxCell. The collaboration will allow both companies to rapidly move forward in their respective fields with enhanced technology platforms, access to cGMP grade iPSC lines and the ability to generate a wide variety of therapeutic grade products.

"RxCell's hypo-immunogenic cell platform complements our cloaking platform and allows us to develop novel tissue-specific hypo-immunogenic cell lines" said Dr. Andras Nagy, the inventor of the cloaking technology otherwise known as panCELLa's iACT (Stealth Cells). Dr. Zeng added that she was particularly pleased to have access to cGMP grade engineered Master Cell Banks that utilized Sigma/Merck CRISPR-based technology to incorporate the safe harbor technology.

Dr. Rao CEO of Implant Therapeutics added "I believe that the MSC platform developed by the two companies combines the proven power of MSC with the engineering expertise of panCELLa and this will make RxCell and Implant leaders in their respective fields."

About Implant Therapeutics

Implant provides hypoimmunogenic and safe harbor engineered IPSC derived cellsin order to deliver the ultimate therapeutic MSC products. To learn more, visit https://www.implant-rx.com/

About panCELLa

Founded in 2015, panCELLa is a privately-held early-stage biotechnology firm based on the innovative technology developed in Dr. Andras Nagy's lab at the Sinai Health System (SHS). panCELLa has created platforms that allow for the development of safe, universal, "off-the-shelf" cell lines. To learn more, visit https://pancella.com.

About RxCell

RxCell is a biotechnology company focused on therapeutic applications of induced pluripotent stem cells (iPSC). We have developed several therapeutic grade iPSC line seed banks and are in the process of manufacturing a large Master Cell Bank to support our activities. To learn more, visit https://www.rxcellinc.com/

SOURCE panCELLa Inc.

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Accelerating cell-based therapies by providing safe therapeutic MSC products - BioSpace

Exacis Biotherapeutics Announces Its Launch and mRNA Technology In-Licensing For Targeted CAR-NK And CAR-T Cell Cancer Therapies | DNA RNA and Cells |…

Details Category: DNA RNA and Cells Published on Friday, 08 January 2021 07:36 Hits: 379

-- Focuses on immuno-oncology

-- Creates innovative, engineered T and NK cells from induced pluripotent stem cells (iPSC)

-- In-licenses mRNA technologies developed by Factor Bioscience

-- Uses mRNA-based approach to create cell therapies - avoids viruses and DNA

-- Names key executives including Gregory Fiore, MD, as Chief Executive Officer

CAMBRIDGE, MA, USA I January 6, 2021 I Exacis Biotherapeutics, Inc., a development-stageimmuno-oncology company working to harness the immune system to cure cancer,today announcedits formation along with completion of in-licensing of certain technologies from Factor Bioscience, a leading cell sciences company. The exclusive license allows Exacis to create allogeneic engineered T and NK cells from induced pluripotent stem cells (iPSC). Exacis'next generation approachavoids useof DNA andviruses by usingmRNA.The technologies will be used for generatingiPSC and for performing genetic editing to create stealthed, allogeneic cell products, termed ExaCAR-Tor ExaCAR-NKcells.

Exacis also announcedthe addition of key members to its leadership team, Scientific Advisory Board and Board of Directors. Gregory Fiore, MD,a Harvard trained physician, seasoned pharmaceutical executiveand serial entrepreneur, has been named Chief Executive Officer.Dr. Fiore is joined on the management team by co-founder and Head of Discovery and Development, James Pan, PhD,an entrepreneur andbiologics expert. DimitriosGoundis, PhD, formerly CEO of MaxiVAX, a private Swiss immuno-oncology company, joins Exacis as the Chief Business Officer.

Exacis was launched by Factor Bioscience with an exclusive license to its intellectual property for developing targeted, allogeneic cell therapies for cancer treatment. Factor CEO Matthew Angel, PhD,is the Chair of Exacis'Scientific Advisory Board and is joined on the SAB by Factor Co-Founder Christopher Rohde, PhD, Eric Westin, MD,and Gunnar Kaufmann, PhD. Exacis' Board of Directors is chaired by Mark Corrigan,MD, a highly successfuldrug developer,biotechnology CEO and Board Chairperson.

Commenting on the new endeavor, Dr. Fiore said, "This is a wonderful opportunity to create innovative, next-generation NK and T cell therapies to improve outcomes and experiences for patients with challenging liquid and solid tumors."

Exacis' Board Chairman Corrigan added, "The ground- breaking science Exacis has in-licensed, along with the team we are building, provide a strong foundation for developing successful targeted cell therapies for the treatment of cancer."

Exacis has secured initial seed funding and is seeking to raise Series A funding in early 2021. The company has initiated discussions with several potential development collaborators.

About Exacis Biotherapeutics

Exacis is a development stage biotechnology company focused on harnessing the human immune system to cure cancerby engineering off-the-shelf NK and T cell therapies aimed at liquid and solid tumors.Exacis was founded in 2020 with an exclusive license to a broad suite of patents covering the use oftechnologies developed by Factor Biosciences.

About Factor Bioscience

Founded in 2011, Factor Bioscience develops technologies for engineering cells to advance the study and treatment of disease. It actively licenses its technologies to entities wishing to conduct commercial research, sell tools, reagents and other products, perform commercial services for third parties, and develop human and veterinary therapeutics. Factor Bioscience is privately held and is headquartered in Cambridge, MA.

About T and Natural Killer (NK) Cell Therapies

T and NK cells are types of human immune cells that are ableto recognize and destroy cancer cells and can be modified through genetic engineering to target specific tumors.

SOURCE: Exacis Biotherapeutics

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Exacis Biotherapeutics Announces Its Launch and mRNA Technology In-Licensing For Targeted CAR-NK And CAR-T Cell Cancer Therapies | DNA RNA and Cells |...

Environmental Factor – January 2021: Intramural Papers of the Month – Environmental Factor Newsletter

Intramural Papers

Intramural By Sanya Mehta, Victoria Placentra, Saniya Rattan, Nancy Urbano, Qing Xu

Researchers in the Division of the National Toxicology Program (DNTP) examined the long-term use of hydroxyurea (HU) therapy, the most effective strategy for managing sickle cell anemia, a genetic disorder of the blood. HU effectively increases healthy fetal hemoglobin production, but through a mechanism that is harmful to cells. The use of HU and its adverse side-effects are well-managed in adults. However, the U.S. Food and Drug Administration only recently approved HU for use in children and data is limited for understanding the impact the drug may have on child development.

The scientists conducted critical preliminary studies to identify appropriate doses for evaluating long-term effects. They assessed HU kinetics, or the movement of the chemical in the body, during critical periods of rodent development. HU was administered to pregnant rats from late gestation through lactation and to their offspring for 34 days after birth. Decreased body weight and adverse clinical observations, such as hair loss, appeared in offspring receiving at least 75 milligrams per kilogram per day. Data revealed gestational transfer of HU, but minimal lactational transfer. There was no difference in the half-life of HU between age and sex, but systemic exposure decreased with increasing age. (SM)

Citation:Huang MC, Turner KJ, Vallant M, Robinson VG, Lu Y, Price CJ, Fennell TR, Silinski MA, Waidyanatha S, Ryan KR, Black SR, Fernando RA, McIntyre BS. 2020. Tolerability and age-dependent toxicokinetics following perinatal hydroxyurea treatment in Sprague Dawley rats. J Appl Toxicol; doi:10.1002/jat.4087 [Online 25 November 2020].

Individual heterogeneity, or genetic variability, can substantially affect reprogramming of somatic cells into induced pluripotent stem cells (iPSCs), according to NIEHS scientists and their collaborators. iPSCs are stem cells that are derived from differentiated cells, such as fibroblasts, and they can both self-renew and are pluripotent, meaning they can be differentiated into other cell-types. In a previous publication, the research team obtained fibroblasts tissue cells from healthy, diverse donors and observed that each persons fibroblasts had consistent differences in the ability to be reprogrammed to iPSCs. Ancestry was identified as a large contributing factor. In this publication, the research team identified genes and pathways that may be responsible for the observed differences.

Using 72 dermal fibroblast-iPSCs from self-identified African Americans and white Americans, the researchers found ancestry-dependent and ancestry-independent genes associated with reprogramming efficiency. These include genes involved in intracellular transport regulation, protein localization, and cytoskeletal organization, as well as dynamic biological processes like cancer and wound healing. The findings suggest that the heterogeneity of an individual can influence iPSC reprogramming, and the scientists suggested that these genes will provide insights into ancestry-dependent regulation of cell fate and reprogramming. (NU)

Citation:Bisogno LS, Yang J, Bennett BD, Ward JM, Mackey LC, Annab LA, Bushel PR, Singhal S, Schurman SH, Byun JS, Napoles AM, Perez-Stable EJ, Fargo DC, Gardner K, Archer TK. 2020. Ancestry-dependent gene expression correlates with reprogramming to pluripotency and multiple dynamic biological processes. Sci Adv 6(47):eabc3851.

NIEHS researchers and their collaborators have developed tools to deliver diphosphoinositol polyphosphates (PP-InsPs) into cultured cells to study their actions. The PP-InsPs are multipurpose cell signaling molecules that regulate diverse biological processes. The few tools that exist to study PP-InsP activities in living cells require hours-long procedures and are plagued by the possibility of off-target effects, thereby compromising short-term studies.

Because the PP-InsPs are highly charged, they cannot enter cells. Therefore, the researchers masked the charge by encapsulating the PP-InsPs inside liposomes. These are minute spherical sacs of phospholipid molecules are similar to those found in cell membranes, except that the researchers used phospholipids that melt at 40 degrees Celsius (i.e., fractionally above body temperature). The liposomes also contain a dye that warms when exposed to biologically harmless red light. These liposomes are readily accumulated by the cells. Finally, the cells are briefly placed under red light for two to five minutes, causing the liposomes to heat, melt, and release their PP-InsP cargo.

To validate this new delivery method, the scientists developed a fluorescent PP-InsP analogue and monitored its release into cells. This new intracellular PP-InsP delivery method is adjustable and applicable to all PP-InsPs and analogs. (SR)

Citation:Wang Z, Jork N, Bittner T, Wang H, Jessen HJ, Shears SB. 2020. Rapid stimulation of cellular Pi uptake by the inositol pyrophosphate InsP8 induced by its photothermal release from lipid nanocarriers using a near infra-red light-emitting diode. Chem Sci 11:1026510278.

In a study of pregnant women in Bangladesh, taking vitamin D supplements was associated with nonsignificant increases in lead levels, but significant increases in cord blood levels of lead and cadmium, according to NIEHS researchers and their collaborators. Vitamin D is important for building healthy bones, but animal studies indicate it increases the absorption of toxic metals a body is exposed to, such as lead, cadmium, manganese, and mercury. The study was the first to examine the effect of prenatal vitamin D supplementation and blood metal levels in a randomized clinical trial.

In the study, 1,300 pregnant women were randomized into groups that received a placebo or weekly doses of either 4,200, 16,800, or 28,000 international units (IU) of vitamin D3.

Randomization occurred in the second trimester and supplementation or placebo were continued throughout pregnancy. At delivery, maternal blood and umbilical cord blood samples were collected, and researchers measured their cadmium, lead, mercury, and manganese levels using a technique called inductively coupled plasma mass spectrometry. The pregnant women who received vitamin D supplementation showed no significant increase in blood metal concentrations compared to the placebo group. However, they were more likely to have infants with higher cord blood lead levels and with detectable cadmium. The authors say further investigation is needed since there is no safe level of toxic metals for infants. (VP)

Citation:Jukic AMZ, Zuchniak A, Qamar H, Ahmed T, Mahmud AA, Roth DE. 2020. Vitamin D treatment during pregnancy and maternal and neonatal cord blood metal concentrations at delivery: Results of a randomized controlled trial in Bangladesh. Environ Health Perspect 128(11):117007.

NIEHS researchers and their collaborators have revealed that genetic factors contribute to development of hypothalamic amenorrhea (HA), a condition in which menstruation stops in women of reproductive age. The finding provides new insight into the development of HA and womens reproductive health.

Studies have shown that HA is more prevalent in women with excessive exercise, food restriction, or psychological stress. Both physical and emotional stressors could cause altered secretion of gonadotropin-releasing hormone (GnRH) from the hypothalamus in the brain. GnRH deficiency, in turn, impairs the synthesis of gonadotropins that are essential for reproduction and fertility and leads to hypogonadotropic hypogonadism (HH). Several rare, pathogenic sequence variants in genes that control the development or function of GnRH have been identified in individuals with a rare syndrome called isolated hypogonadotropic hypogonadism (IHH), an inherited form of HH. Due to the varied menstrual and hormonal response to similar stressors, this study investigated whether genetic variation influenced individual susceptibility to known risk factors for HA.

The researchers sequenced all the protein-coding regions of genes in women with HA and women in the control group. After comparing the frequency of rare variants in more than 50 IHH-associated genes, they found HA patients had a greater burden of variants than the control heathy women, confirming the genetic impact on the development of HA. (QX)

Citation:Delaney A, Burkholder AB, Lavender CA, Plummer L, Mericq V, Merino PM, Quinton R, Lewis KL, Meader BN, Albano A, Shaw ND, Welt CK, Martin KA, Seminara SB, Biesecker LG, Bailey-Wilson JE, Hall JE. 2020. Increased burden of rare sequence variants in GnRH-associated genes in women with hypothalamic amenorrhea. J Clin Endocrinol Metab; doi: 10.1210/clinem/dgaa609 [Online 1 September 2020].

(Sanya Mehta is an Intramural Research Training Award [IRTA] postbaccalaureate fellow in the NIEHS Matrix Biology Group. Victoria Placentra is an IRTA postbaccalaureate fellow in the NIEHS Mutagenesis and DNA Repair Regulation Group. Saniya Rattan, Ph.D., is an IRTA fellow in the NIEHS Reproductive Developmental Biology Group. Nancy Urbano is an IRTA postbaccalaureate fellow in the DNTP Predictive Toxicology and Screening Group. Qing Xu is a biologist in the NIEHS Metabolism, Genes, and Environment Group.)

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Environmental Factor - January 2021: Intramural Papers of the Month - Environmental Factor Newsletter