Stem Cell Clinic

Jasper Therapeutics Announces Positive Clinical Data from Investigator Sponsored Study of JSP191 Conditioning in Fanconi Anemia Patients at IEWP…

REDWOOD CITY, Calif., Sept. 26, 2022 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (NASDAQ: JSPR), a biotechnology company focused on hematopoietic cell transplant therapies, today announced that data from the companys investigator-sponsored study of JSP191 as a conditioning agent in the treatment of Fanconi Anemia were presented at the annual conference of the Inborn Errors Working Party (IEWP), a research group of the European Society of Blood and Marrow Transplantation, held on September 23-25, 2022, in Paris, France.

The study is a Phase 1/2 clinical trial (NCT04784052) utilizing JSP191 to treat Fanconi Anemia patients in bone marrow failure requiring allogeneic transplant with non-sibling donors. The objective of the study is to develop cell therapy for Fanconi Anemia which enables enhanced donor hematopoietic and immune reconstitution with decreased toxicity by transplanting TCR ab+ T-cell/CD19+ B-cell depleted stem cells from a donor, after using JSP191 as a part of conditioning. Primary outcome measures include the number of patients without treatment-emergent adverse events following the administration of JSP191.

In the data series presented, 100% complete donor chimerism was achieved through six months for the first patient and at one month for the second patient. Neutrophil engraftment was reached on day 11 for both patients and platelet engraftment was achieved on days 9 and 14. JSP191 was cleared by day 9 after dosing and no treatment-related adverse events or toxicities were observed.

Patients affected by Fanconi anemia have increased sensitivity to conventional conditioning regimens and radiation due to innate defects in DNA repair, said Ronald Martell, President, and CEO of Jasper Therapeutics. JSP191 offers a targeted conditioning strategy that eliminates the need for radiation or alkylating agents like busulfan. Initial data from this study suggest that a conditioning regimen that includes JSP191 has the potential to achieve successful donor transplant with no JSP191-related adverse events or toxicities reported to date. The positive update presented gives us increased confidence in JSP191, which has now shown promise as a conditioning agent in four indications including acute myeloid leukemia, myelodysplastic syndromes, severe combined immunodeficiency, and Fanconi anemia. We look forward to continuing support for Stanfords investigation of JSP191 and advancing our broader pipeline for JSP191 to the next phase of development.

The details of the oral presentation are as follows:

Title: JSP 191 clinical trial update Session Name: Conditioning for HSCT in IEI Presenter: Rajni Agarwal-Hashmi, M.D., Professor of Pediatrics and Stem Cell Transplantation, the Stanford University School of Medicine Date/Time: Saturday, September 24, 2022, 2 pm CEST Location: The Imagine Institute in Paris, France

About Fanconi Anemia Fanconi Anemia (FA) is a rare but serious blood disorder that prevents the bone marrow from making sufficient new red blood cells. The disorder can also cause the bone marrow to make abnormal blood cells. FA typically presents at birth or early in childhood between five and ten years of age. Ultimately it can lead to serious complications, including bone marrow failure and severe aplastic anemia. Cancers such as AML and MDS are other possible complications. Treatment may include blood transfusions or medicine to create more red blood cells, but a hematopoietic stem cell transplant (HSCT) is the only cure.

About JSP191

JSP191 is a humanized monoclonal antibody in clinical development as a conditioning agent that blocks stem cell factor receptor signaling leading to clearance of hematopoietic stem cells from bone marrow, creating an empty space for donor or genetically modified transplanted stem cells to engraft. To date, JSP191 has been evaluated in more than 100 healthy volunteers and patients. Four clinical trials for acute myeloid leukemia (AML)/ myelodysplastic syndromes (MDS), severe combined immunodeficiency (SCID), sickle cell disease (SCD) and Fanconi anemia are currently ongoing. The Company plans a new study of JSP191 as a second-line therapeutic in lower-risk MDS patients in 2022 as well as to a pivotal study in AML/MDS transplant in early 2023. Enrollment in additional studies are planned in patients with chronic granulomatous disease and GATA2 MDS who are undergoing hematopoietic cell transplantation as well as a study of JSP191 as a chronic therapeutic for low to intermediate risk MDS patients.

About Jasper Therapeutics

Jasper Therapeutics is a biotechnology company focused on the development of novel curative therapies based on the biology of the hematopoietic stem cell. The company is advancing two potentially groundbreaking programs. JSP191, an anti-CD117 monoclonal antibody, is in clinical development as a conditioning agent that clears hematopoietic stem cells from bone marrow in patients undergoing hematopoietic cell transplantation. It is designed to enable safer and more effective curative allogeneic hematopoietic cell transplants and gene therapies. In parallel, Jasper Therapeutics is advancing its preclinical mRNA Stem Cell Graft Platform which is designed to overcome key limitations of allogeneic and autologous gene-edited stem cell grafts. Both innovative programs have the potential to transform the field and expand hematopoietic stem cell therapy cures to a greater number of patients with life-threatening cancers, genetic diseases, and autoimmune diseases than is possible today. For more information, please visit us at jaspertherapeutics.com.

Forward-Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as believe, may, will, estimate, continue, anticipate, intend, expect, should, would, plan, predict, potential, seem, seek, future, outlook and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the potential long-term benefits of hematopoietic stem cells (HSC) engraftment following targeted single-agent JSP191 conditioning in the treatment of severe combined immunodeficiency (SCID) and Jaspers ability to potentially deliver a targeted non-genotoxic conditioning agent to patients with SCID. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Jaspers product candidates; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that Jaspers product candidates may not be beneficial to patients or successfully commercialized; patients willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jaspers business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jaspers business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics, including the ongoing COVID-19 pandemic; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jaspers filings with the SEC. If any of these risks materialize or Jaspers assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jaspers assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Contacts: John Mullaly (investors) LifeSci Advisors 617-429-3548 jmullaly@lifesciadvisors.com

Jeet Mahal (investors) Jasper Therapeutics 650-549-1403 jmahal@jaspertherapeutics.com

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Jasper Therapeutics Announces Positive Clinical Data from Investigator Sponsored Study of JSP191 Conditioning in Fanconi Anemia Patients at IEWP...

Mesenchymal stem cells market is projected to grow at a CAGR of 13.82% by 2032: Visiongain Research Inc – Yahoo Finance

Visiongain Reports Ltd

Visiongain has published a new report entitled Mesenchymal Stem Cells Market 2022-2032. It includes profiles of Mesenchymal Stem Cells Market and Forecasts Market Segment by Type {Product (Cell & Cell Lines, Kits Media & Reagents, Others), Services}, Market segment by Source (Bone Marrow, Adipose Tissue, Cord Blood, fallopian Tube, Fetal Liver, Lung, Peripheral Blood, Other Sources), Market Segment by Indication (Bone & Cartilage Repair, cardiovascular Disease, Cancer, GvHD, Inflammatory & Immunological Diseases, Liver Diseases, Other Diseases), Market Segment by Application (Disease Modelling, Drug Discovery & Development, Stem Cell Banking, Tissue Engineering, Toxicology Studies, Other Applications) plus COVID-19 Impact Analysis and Recovery Pattern Analysis (V-shaped, W-shaped, U-shaped, L-shaped), Profiles of Leading Companies, Region and Country.

The mesenchymal stem cells market was valued at US$2.44 billion in 2021 and is projected to grow at a CAGR of 13.82% during the forecast period 2022-2032.

Rising Awareness About Therapeutic Potential of Mesenchymal Stem Cells The mesenchymal stem cell (MSC) market has a huge potential for expansion as it's the most prevalent stem cell type used in regenerative medicine. MSCs are now the most commonly used stem cell type in clinical trials and the most researched stem cell type in the scientific literature. MSC-based therapies are also gaining popularity due to the rapidly aging population and rising prevalence of chronic diseases. Mesenchymal Stem cells play a significant role in effective management of disease and research initiatives in specialized areas such as genomic testing and personalized medicine. As a result of rising awareness of the therapeutic potential of stem cells and the scarcity of effective therapeutic treatments for rare diseases there is rise in investment leading to the growth of the market, however significant operational cost associated with the mesenchymal stem cell expansion and banking is anticipated to hinder the market growth.

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Mesenchymal Stem Cells Market Report 2022-2032

How has COVID-19 had a Significant Negative Impact on the Mesenchymal Stem Cells Market?

The biotechnology industry has experienced evolutionary changes with regards to the operational management. Typical biopharmaceutical companies manufacturing products for mesenchymal stem cell development had a better response to staff disruptions and challenges evolving due to COVID-19.

There was an impact on the research & development activities and clinical trials as there were interruptions in the new patient enrolment for the active clinical trial. However, the business focused on inventing new therapies for the treatment of COVID-19 disease. In the past years, MSCs have established itself to be an effective technique to treat pulmonary disease, including COVID-19. MSC derived stem cell therapies have showed the potential for the treatment of the Covid 19 disease. Therefore, an increase in the number of clinical trials using MSCs has been observed. Countries such as the US, the UK, Belgium, France, Spain and Mexico are conducting clinical trials with mesenchymal stem cells to be used in the treatment of COVID-19.

How will this Report Benefit you?

Visiongains 281-page report provides 117 tables and 184 charts/graphs. Our new study is suitable for anyone requiring commercial, in-depth analyses for the mesenchymal stem cells market, along with detailed segment analysis in the market. Our new study will help you evaluate the overall global and regional market for Mesenchymal Stem Cells Market. Get financial analysis of the overall market and different segments including type, Source, Indication, Application, and company size and capture higher market share. We believe that there are strong opportunities in this fast-growing mesenchymal stem cells market. See how to use the existing and upcoming opportunities in this market to gain revenue benefits in the near future. Moreover, the report will help you to improve your strategic decision-making, allowing you to frame growth strategies, reinforce the analysis of other market players, and maximise the productivity of the company.

What are the Current Market Drivers?

MSCs in the Development of Engineered Tissues and Organs hMSCs are considered as one of the prominent bio fabrication materials for decades as they are proved safe and effective in treating various injuries and diseases such as bone or cartilage regeneration, stroke & cancer. Bioprinting is a rapidly expanding tissue engineering area with a lot of promise for product customization and addressing the global tissue and organ scarcity, with a global market of $1.82 billion USD predicted by 2022. hMSCs have also been found to be capable of being guided toward hepatocyte differentiation thus indicating huge demand for hMSCs as tissue engineering of organ develops. The requirement for hMSC in engineered tissue and organ applications is, of course, reliant on cell generation, differentiation, and maturation technologies for the parenchymal cells required for organ function and thus it is expected that the increased availability of hMSC sources as a result of manufacturing technology advancements will pave the way for quick improvement and growth of the mesenchymal stem cells market.

Rise in Focus Towards Regenerative Medicine Therapies MSCs are a good cell source for tissue regeneration because of the following characteristics. MSCs can be sourced from various tissue, including umbilical cord, fetal liver, bone marrow, and synovium. MSCs have the ability to develop into practically any end-stage lineage cell, allowing them to seed specific scaffolds. MSCs are potential immune tolerant agents as they have characteristics such as anti-inflammatory, immunoregulatory & immunosuppressive. Several clinical papers back up MSC-based cell therapy's potential efficacy; while its efficacy is still restricted, the results are encouraging.

MSCs have been investigated and used extensively in regenerative medicine. MSCs have moved closer to therapeutic applications for disease therapy and tissue repair in recent years due to improvements in extraction, culture, and differentiation procedures , therefore future research into better biomaterials and effective inducing factors will help MSCs advance in their regenerative medicine applications.

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Mesenchymal Stem Cells Market Report 2022-2032

Where are the Market Opportunities?

MSC Therapy to Treat Multiple Sclerosis The therapeutic application of MSCs in treating Multiple Sclerosis has proved to provide huge potential by improving clinical symptoms, thereby stabilizing the disease progression. MSCs have properties such as immunomodulator, tissue-protector and repair promotion has proved MSCs to be an attractive therapy option in the treatment of Multiple Sclerosis as well as in other conditions such as inflammation and tissue injury.

MSCs when administered, combat the inflammation in body and regulate the immune system which will further prevent myelin degradation. Clinical trials demonstrating the application of MSCs in Multiple Sclerosis patients have shown increased energy levels, improved flexibility, strength, and mobility. It has also been observed that if MSCs are administered intravenously may have the ability to halt diseases progression for an extended time duration.

MSCs offer intrinsic benefits over hematopoietic stem cells, that MSCs can differentiate into a cell types, release immunoregulatory molecules and promote release of exosome and growth factors

Competitive Landscape The major players operating in the mesenchymal stem cells market are Thermo Fischer Scientific Inc., Merck KGaA (Millipore Sigma), STEMCELL Technologoes Inc., Cytori Therapeutics Inc. (Plus Therapeutics Inc.), Cyagen Biosciences, PromoCell GmbH, Celprogen Inc. Stemedica Cell Technologies Inc., Cell Application Inc., Lonza, Celltex Therapeutics Corporation. These major players operating in this market have adopted various strategies comprising M&A, investment in R&D, collaborations, partnerships, regional business expansion, and new product launches.

Recent Developments

In August 2022, to meet rising demand for cell culture media globally used in the development and manufacturing of new biologics and vaccines, Thermo Fisher Scientific enhanced its dry powder media manufacturing facility in Grand Island, New York.

In March 2022, new large-volume electroporation technology was unveiled by Thermo Fisher Scientific, making it simpler for inventors of cell therapies to transition from clinical development to commercial manufacture. Without the use of conventional viral vectors, the Gibco CTS Xenon Electroporation System facilitates gene changes through the use of a closed

In March 2019, Celltex Therapeutics entered into an agreement with Saudi Arabias Research Products Development Company (RPDC) to help with the promotion and marketing of Celltexs proprietary stem cell technology.

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Do you have any custom requirements we can help you with?Any need for a specific country, geo region, market segment or specific company information? Contact us today, we can discuss your needs and see how we can help:dev.visavadia@visiongain.com

About Visiongain

Visiongain is one of the fastest-growing and most innovative independent market intelligence providers around, the company publishes hundreds of market research reports which it adds to its extensive portfolio each year. These reports offer in-depth analysis across 18 industries worldwide. The reports, which cover 10-year forecasts, are hundreds of pages long, with in-depth market analysis and valuable competitive intelligence data. Visiongain works across a range of vertical markets with a lot of synergies. These markets include automotive, aviation, chemicals, cyber, defence, energy, food & drink, materials, packaging, pharmaceutical and utilities sectors. Our customised and syndicatedmarket research reportsoffer a bespoke piece of market intelligence customised to your very own business needs.

Contact: Dev Visavadia PR at Visiongain Reports Limited Tel: + 44 0207 336 6100 Email: dev.visavadia@visiongain.com

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Mesenchymal stem cells market is projected to grow at a CAGR of 13.82% by 2032: Visiongain Research Inc - Yahoo Finance

CellResearch Corporation (CRC) to present promising new stem cell products for the treatment of chronic diabetic foot ulcers at the world’s premier…

- CRC data on cord lining media for the treatment of diabetic foot ulcers has been accepted at the DFCon, with Dr Wong Keng Lin Francis, CRC's latest KOL, presenting his findings to world leaders in the field of DFU. - Similarly, the results of Corlicyte's Phase 1 study on the treatment of chronic diabetic foot has also been accepted with the presentation being given by Dr Cecilia Low-Wang, the trials Principal Investigator. - DFCon is a global specialist multi-disciplinary congress that attracts specialists in the field of the diabetic foot and is considered the most influential event in the industry. It is co-founded by Dr David Armstrong, a pre-eminent expert in diabetic foot. - Dr Armstrong, who also serves on CRC's scientific advisory board, will be giving the opening address for CRC's breakfast symposium on their lead products Sollagen and Corlicyte. - CorLiCyte is an umbilical cord lining stem cell therapy, for patients suffering with diabetic foot ulcers (DFU), Sollagen is a brand targeting diabetic's skin. - Global diabetes patient population is set to grow from 537 million in 2021 to 783 million in 20451- DFU is a global health emergency that will affect close to 20% of the diabetic population in their lifetime

LOS ANGELES, Sept. 26, 2022 /PRNewswire/ -- CRC is delighted to announce attendance at DFCon, the global specialist multidisciplinary congress focused on the diabetic foot held in late September 2022 in Los Angeles, USA. The meeting is a gathering of a wide range of both generalists and specialists who diagnose and manage diabetic feet, to discuss best practice in diagnostics and interventions for both treatment and amputation prevention. It was co-founded and is co-chaired by Dr David Armstrong, a pre-eminent expert in diabetic foot who also serves on CRC's scientific advisory board.

Dr David Armstrong will be introducing CRC's headline symposium on Saturday morning where Dr Paul Kemp, the inventor of Apligraf and scientific advisory board member, and esteemed researchers Dr Brian Freed and Dr Wong Keng Lin Francis will present an overview of CRC's technology and data.

Furthermore, CRC have two scientific posters approved for presentation at DFCon on the data generated in Corlicyte and Sollagen:

The first poster "Results of the phase 1 open-label safety study of umbilical cord lining (Corlicyte) to heal chronic diabetic foot ulcers" details the Phase I study in Corlicyte and is authored by Cecilia Low Wang and the team from the University of Colorado who conducted the study.

The second poster by Dr Wong from Sengkang General Hospital/Duke NUS is titled "Early evaluation of Sollagen, a topical exosomal skin conditioner derived from Umbilical cord lining cell media, in treatment of persistent chronic DFU" and details the impressive early data generated with Sollagen in chronic diabetic foot ulcers.

Both posters are a testament to the immense potential of Corlicyte and Sollagen for the treatment of diabetic foot ulcer, a huge issue for patients and health care systems alike.

CRC's presence at such a specialized and well-regarded scientific and medical forum reflects the exciting data the company is generating. It is a strong indication of the academic and clinical network that the company is building to deliver products that can make a dramatic difference to patients with a large unmet medical need.

About CellResearch Corporation (CRC)

CellResearch Corporation was founded in 2002 as a contract research provider focusing on skin cells. In 2004, the company made the discovery that the umbilical cord lining of mammals was an abundant source of both mesenchymal and epithelial stem cells. Today, the company owns this technology through a family of patents and holds the rights to commercialize this technology in most major markets globally. While the closure of diabetic foot ulcers is the company's first allogeneic therapy to make it to the end of Phase 1 USFDA clinical trials, CellResearchCorp has a broad therapeutic pipeline at the pre-clinical stage. Further therapies include solid tumor therapy, inflammatory diseases, cardiac muscle repair, Parkinson's Disease, Age-related Macular Degeneration and Diabetes.

CellResearch Consumer Health, a wholly owned subsidiary of CellResearch Corp, is the commercialization vehicle for CALECIMProfessional and the newly launching Sollagen. It produces an innovative range of skincare and haircare products using cord lining stem cell media to power its products. It is used in clinics/hospitals and as part of an at-home anti-aging skincare regime. It is distributed globally through over 600 aesthetic physicians and online via their own website. It has a key distribution partnership with Menarini Group across Southeast Asia.

CellResearch Corp partner, Cordlife offers parents the opportunity to bank their child's umbilical cord tissue alongside their cord blood. Cordlife has what is believed to be the largest licensed bank of umbilical cord tissue globally. As cell therapies move into the clinic, Cordlife will have the ability to expand stem cells from a banked umbilical cord for autologous and donor-related uses.

http://www.cellresearchcorp.com

https://calecimprofessional.com

Business Development and Investor Relations:

Xavier Simpson

+65 8815 6139

xaviersimpson@cellresearchcorp.com

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CellResearch Corporation (CRC) to present promising new stem cell products for the treatment of chronic diabetic foot ulcers at the world's premier...

Neurona Therapeutics Presents Clinical Case Study from First Human Trial of Regenerative Cell Therapy, NRTX-1001, in Adults with Drug-Resistant Focal…

Clinical assessments three-months post-treatment report no serious adverse events and reduced seizure frequency to date in first trial participant

Data Safety Monitoring Board clears advancement of trial to continue enrollment

Pioneering cell therapy approach could provide a disease-modifying treatment for drug-resistant focal epilepsy

Data presented at ISSCR-ASGCT Conference: Emerging Therapies at the Intersection of Genetic and Cellular Technologies

SAN FRANCISCO, Sept. 21, 2022 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapies for the treatment of neurological disorders, today announced the presentation of a clinical case study from the initial dose cohort of the Phase 1/2 first-in-human epilepsy clinical trial of its lead program, NRTX-1001. The data from three months post-cell therapy administration to the first patient in this study show that there were no serious adverse events associated with NRTX-1001 treatment and that the patient has thus far experienced reduced seizure frequency from an average prior history of 30+ seizures per month to four seizures in total during three months of follow-up to date. The data are being presented by Catherine Priest, Ph.D., Neuronas chief development officer at the ISSCR-ASGCT Conference: Emerging Therapies at the Intersection of Genetic and Cellular Technologies being held in Madison, WI, September 21 -23, 2022.

The reduced number of seizures reported by the first person to receive NRTX-1001 is very encouraging, and we remain cautiously optimistic that this reduction in seizure frequency will continue and extend to others entering this cell therapy trial. NRTX-1001 administration has been well tolerated thus far in the clinic, which is in line with the extensive preclinical safety data collected by the Neurona team, said Cory R. Nicholas, Ph.D. Neuronas president and chief executive officer. With recent clearance from the Data Safety Monitoring Board we are excited to continue patient enrollment. We are very grateful to these first participants, and thank the clinical teams for the careful execution of this pioneering study.

In addition to the preclinical data supporting the clinical program, the presentation highlights initial data from the first patient treated in Neuronas clinical trial who received a starting dose of NRTX-1001. The patient is a young adult male with a 9-year history of seizures and was diagnosed with unilateral mesial temporal lobe epilepsy (MTLE). In the six months prior to the administration of NRTX-1001, the patient experienced an average of 32 seizures per month, despite being on several antiepileptic medications. The patient received NRTX-1001, and the treatment was well tolerated; there have been no serious adverse events to date. The patient has reported having four seizures during the first three months since receiving NRTX-1001.

The clinical trial is funded in part by the California Institute for Regenerative Medicine (DISC2-10525; TRAN1-11611; CLIN2-13355).

About Neuronas Clinical Trial of NRTX-1001 for Mesial Temporal Lobe Epilepsy (MTLE) Neuronas multicenter, Phase 1/2 clinical trial is designed to evaluate the safety and efficacy of a single administration of NRTX-1001 for drug-resistant MTLE. The first stage of the trial is an open-label dose-escalation study in up to 10 people with MTLE, with five patients to be treated at a starting dose and five at a higher dose. Patients treated with a single infusion of NRTX-1001 cells will be monitored for safety, tolerability, and effects on their epilepsy disease symptoms. Patient recruitment is underway at epilepsy centers across the United States. For more information, please visit http://www.clinicaltrials.gov (NCT05135091). The first part of the clinical trial is supported by a recently announced $8.0 million grant from the California Institute for Regenerative Medicine (CIRM; CLIN2-13355).

About NRTX-1001 NRTX-1001 is a regenerative neural cell therapy candidate derived from human pluripotent stem cells. The fully-differentiated neural cells, called interneurons, secrete the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). Delivered as a one-time dose, the human interneurons are intended to integrate and innervate on-target, providing long-term GABAergic inhibition to repair hyper-excitable neural networks.

About Mesial Temporal Lobe Epilepsy (MTLE) An estimated three million Americans have epilepsy, and 25 to 35 percent live with ongoing seizures despite treatment with approved drugs, which means that there is a huge unmet medical need in this community. MTLE is the most common type of focal epilepsy in adults and primarily affects the internal structures of the temporal lobe, where seizures often begin in a structure called the hippocampus. For people with seizures that are resistant to anti-seizure drugs, epilepsy surgery, where the damaged temporal lobe is surgically removed or ablated by laser, can be an option. However, the current surgical options are not available or effective for all, are tissue-destructive, and can have significant adverse effects.

About Neurona Neuronas regenerative cell therapy candidates have single-dose curative potential. Neurona is developing off-the-shelf, allogeneic neuronal, glial, and gene-edited cell therapy candidates that are designed to provide long-term repair of dysfunctional neural networks for multiple neurological disorders. For more information about Neurona, visit http://www.neuronatherapeutics.com

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Reprogramming pig cells leads way for new regenerative therapies – National Hog Farmer

A new approach is paving the way for improved stem cell therapies and regenerative applications using cells from pigs. Led by Wan-Ju Li, a SCRMC researcher and associate professor in the Department of Orthopedics and Rehabilitation and the Department of Biomedical Engineering, this new study published in Scientific Reports offers a viable strategy to enhance the generation of induced pluripotent stem cellsfrom large animal cells and provides researchers with insight into the underlying mechanism controlling the reprogramming efficiency of cells. In turn, this approach will allow researchers to reprogram cells more efficiently into iPSCs which can be used to study regenerative therapies aimed at treating everything from osteoarthritis to heart disease.

While this approach can be applied to regenerative therapies targeting any organ or tissue, Li and his Musculoskeletal Biology and Regenerative Medicine Laboratory study cartilage, so he developed the model by deriving iPSCs from the fibroblast cells of three different breeds of miniature pigs including Wisconsin miniature swine, Yucatan miniature swineand Gttingen minipigs. Fibroblast cells are easily obtained for cellular reprogramming and Li is interested in using these cells to efficiently develop cartilage cells that can be used to help patients experiencing osteoarthritis. But, while his goal for the study was specific, the model has wide-reaching implications.

"This model we created can be used for many applications," says Li. "In successfully developing iPSCs from three different breeds of minipigs, we learned we can take somatic skin cells from these pigs that we programmed ourselves into iPSCs and then inject them back into the same animal to treat the disease. Or we can take the cell that carried the disease gene and put that into the culture dish and use that as a disease model to study disease formation."

Li explained that iPSCs can be created from nearly any type of somatic cell, such as skin or blood cells, that are reprogrammed back into an embryonic-like pluripotent cells. These pluripotent stem cells are the bodys master cells and are, therefore, able to become nearly any cell in the body. Harnessing the power of such a cell and being able to grow these versatile cells in the lab is invaluable to medicine as these cells can be used for the regeneration or repair of damaged tissue and in drug testing to see how medication will impact heart, liver, or other cells within the body.

Through this research, Li and his lab have provided researchers with insight into the underlying mechanism controlling the reprogramming efficiency of iPSCs, allowing researchers to harness to power of iPSCs and develop them more efficiently. Specifically, he discovered that the expression level of the switch/sucrose nonfermentable component BAF60A, which is essentially a protein that can remodel the way DNA is packaged, helps to determine the efficiency of iPSC generation. He also noted that the BAF60A is regulated by STAT3, a transcription factor protein that plays a role in cell growth and death. Through this, Li discovered that the efficiency of iPSC generation is based on the expression level of these proteins and that the expression levels vary among pig breeds.

"While we successfully developed iPSCs and programmed iPSCs from the three different strains of pig, we noticed that some pigs had a higher reprogramming efficiency,"says Li. "So, the second part of our findings, which is significant in biology, is understanding how these differences occur and why."

Li shared that understanding why different pig breeds have varying levels of reprogramming efficiency will directly translate to understanding differences in the effectiveness of iPSC generation between individual humans. In fact, a previous study by Mackey et al., has shown that a person's ethnicity may impact their cell's reprogramming efficiency. So, understanding what mechanisms control cellular reprogramming will be crucial to developing effective protocols of iPSC generation for individualized therapies.

"With this model, we can study musculoskeletal regeneration particularly cartilage regeneration for osteoarthritis patient,"says Li. "But we think the impact is way beyond the application of orthopedics because from now on, anybody on campus who is interested in using the technology we have developed for a minipig model, can reprogram their cells into iPSCs and then these cells and the animal can be used to investigate heart disease, kidney disease, neuronal diseaseor any type of a disease."

Translating this research to improve human health, is deeply important to Li. He has spent much of his career studying novel approaches to regenerate cartilage and bone for orthopedic applications and developing a translational model like this means that science is one step closer to healing more patients using stem cells.

"I feel really touched by the stories people share. You cannot imagine how many emails come in asking me if they can become the first human patient in our future clinical trial,"Li says. "People are in desperate need for something, especially when those people feel the current surgical procedure or intervention is not suitable for them. I have to keep saying, 'wait for another two, three years, maybe we'll be ready for a clinical trial,'but for me, it's time to move on and really do our larger animal studies to fulfill our promise. At least that way, I can fill the gap between the lab and clinical trials as the larger animals must be studied before you go into a clinical trial."

Li's development of a reliable and translational model for the generation of iPSCs in a large animal is critical as it has been a challenge to generate pig iPSCs with efficiency. The reprogramming efficiency of pig cells is relatively low compared to that of human or mouse cells, but large animal studies remain a crucial step in bringing treatments to clinical trials.

Interest in moving these treatments forward has grown and while this study was funded in part by NIH, Li also received support from the Plunkett Family Foundation in Milwaukee through their donation to the UW Stem Cell and Regenerative Medicine Center. After hearing of Li's research, Gwen Plunkett and her daughter Karen visited Li and his lab in 2019 to learn more and were inspired to support research into stem cells for cartilage regeneration.

"Innovation in medicine sparks critical change, for the world and the survival of our species and the Plunkett Family mission is to be a catalyst in stem cell and regenerative medicine research,"says Karen Plunkett. "We supported Jamie Thomson's lab in the early days when federal funding for human stem cell research was restricted. More recently, we continued our commitment to this research by supporting Dr. Wan-Ju Li's stem-cell based approaches for regenerating skeletal tissues, cartilageand bone for orthopedic applications. Additionally, it is personally gratifying to be able to support the SCRMC while my son completes his senior year studying neurobiology at UWMadison.We are happy to be part of the University of Wisconsin family."

Li shared that the donation was profoundly impactful and allowed him to further his goal of using stem cells to help patients struggling with osteoarthritis as well as other joint diseases.

"I want to make sure that our findings in stem cell research can be used to help people,"says Li. "I just feel this internal drive to study this area and I feel good knowing this model carries significant weight in terms of its potential for translational stem cell research and the development of therapeutic treatments."

This research was supported by grants from the National Institutes of Health (R01 AR064803) and the Plunkett Family Foundation. The UW Department of Pathology and Laboratory Medicine and UWCCC (P30 CA014520) and the Small Animal Imaging andRadiotherapy Facility and Flow Cytometry Laboratory, supported by UWCCC (P30 CA014520) also provided facilities and services.

Source: University of Wisconsin-Madison, whichis solely responsible for the information provided, and wholly owns the information. Informa Business Media and all its subsidiaries are not responsiblefor any of the contentcontained in this information asset.

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Reprogramming pig cells leads way for new regenerative therapies - National Hog Farmer

Treg Cell-based Therapies Pipeline Landscape Analysis of 22+ Companies by DelveInsight – GlobeNewswire

New York, USA, Sept. 26, 2022 (GLOBE NEWSWIRE) -- Treg Cell-based Therapies Pipeline Landscape Analysis of 22+ Companies by DelveInsight

Given the various benefits offered, including high target specificity, customization potential and ability to generate immunological memory, regulatory T-cell (Treg) therapies have garnered significant attention among key industry stakeholders for the treatment of various oncological and non-oncological disease indications.

DelveInsights 'Treg Cell-based Therapies Pipeline Insight 2022' report provides comprehensive global coverage of available, marketed, and pipeline Treg cell-based therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Treg cell-based therapies pipeline domain.

Key Takeaways from the Treg Cell-based Therapies Pipeline Report

Request a sample and discover the recent advances in Treg cell-based therapies @Treg Cell-based Therapies Pipeline Outlook

The Treg cell-based therapies pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage Treg cell-based therapies, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the Treg cell-based therapies pipeline landscape.

Treg Cell-based Therapies Overview

Treg cells, which account for 5-7% of CD4+ T cells, develop both directly in the thymus (tTreg cells) and peripherally (pTreg cells). pTreg cells develop from CD4+ conventional T cells, particularly in the gut, in the presence of high levels of transforming growth factor (TGF) and retinoic acid in the environment or in response to metabolites produced by microbiota.

Clinical trials for cellular therapies based on regulatory T (Treg) cells are currently underway for the treatment of autoimmune diseases, transplant rejection, and graft-versus-host disease. Early Treg cell therapy experiences in patients with graft-versus-host disease, type 1 diabetes, and organ transplantation have demonstrated that it is feasible, safe, and potentially efficacious in some settings.

Although there is a clear immunologic rationale for Treg cell therapy, there are numerous challenges at this early stage of implementation and testing. The magnitude of Treg cell ex vivo expansion can vary greatly depending on the patient population and underlying diseases.

Find out more about Treg cell-based therapies @Treg Cell-based Therapies in Development

A snapshot of the Treg Cell-based Therapies Pipeline Drugs mentioned in the report:

Learn more about the emerging Treg cell-based therapies @ Treg Cell-based Therapies Clinical Trials

Treg Cell-based Therapies Therapeutics Assessment

TheTreg cell-based therapies pipelinereport proffers an integral view of the emerging Treg cell-based therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.

Scope of the Treg Cell-based Therapies Pipeline Report

Dive deep into rich insights for Treg cell-based therapies assessment, visit @Treg Cell-based Therapies Therapeutics Assessment

Table of Contents

For further information on the Treg cell-based therapies pipeline therapeutics, reach out @Treg Cell-based Therapies Pipeline Landscape

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Treg Cell-based Therapies Pipeline Landscape Analysis of 22+ Companies by DelveInsight - GlobeNewswire

Congress Introduced with Access to Future Cures Act Aimed at Enabling Precision Medicine for Future Cellular & Gene Therapies – GlobeNewswire

Norwalk, CT, Sept. 26, 2022 (GLOBE NEWSWIRE) -- H.R.8912, the Access to Future Cures Act, was introduced to Congress on September 20th which aims to expand Health Savings Account (HSA), Health Reimbursement Arrangement (HRA), and Flexible Spending Account (FSA) eligibility to include storage of blood or biomaterial derived from blood to enable future cell and gene therapy treatments.

Currently, there are 25 FDA-approved cell and gene therapy products and thousands of clinical trials in development. In fact, the FDA has forecasted 10 to 20 new approvals annually by 2025. As approvals continue to climb, so do the promising results of cellular therapy. For instance, a type 1 diabetes patient received successful treatment with a stem cell-derived pancreatic islet cell replacement therapy called VX-880. According to the Harvard Stem Cell Institute, the patientwho was injection-dependent since their diagnosis 40 years agohad significant restoration of their insulin-producing islet cells after receiving VX-880. This suggests that VX-880 and future cellular therapies may negate the need for people with diabetes to continue using self-injecting insulin.

While many current therapies rely on donor cells, the use of one's own biomaterial allows for better patient outcomes in precision medicine and since cellular health declines over time your healthiest cells are the ones you have today.

I commend this Congress for considering the Access to Future Cures Act which will give millions of Americans with flexible spending and healthcare savings accounts access to high-value preventive healthcare services, said Chris Garcia, Chairman and CEO of GoodCell. With promising cell therapies in development to treat major chronic and debilitating diseases, FSA and HSA eligibility for personal cell storage allows average Americans to store their healthy cells for access to future personalized therapies.

To learn more about GoodCell and how to become a member, visit http://www.GoodCell.com.

About GoodCell:

GoodCell, a life sciences company, delivers proactive, preventive healthcare services that allow members to participate in precision medicine by storing their own biomaterial for potential future personalized cellular therapy. As the pace of cell and gene therapy breakthroughs and FDA approvals continues to accelerate, so do the advantages of Personal Biobanking. Storing healthy cells now gives GoodCell members greater control of their health in the future and may extend quality of life. Learn more at http://www.GoodCell.com.

GoodCell is partnered with Quest Diagnostics for a convenient member experience. Scheduling a blood draw is fast and easy at one of the 3,000+ Quest Labs nationwide. Samples are then sent to GoodCell labs for bioprocessing where the most valuable components of the blood are extracted and safely and securely stored in GoodCells state-of-the-art biorepository.

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Congress Introduced with Access to Future Cures Act Aimed at Enabling Precision Medicine for Future Cellular & Gene Therapies - GlobeNewswire

Strategies to improve the effect of mesenchymal stem cell therapy on inflammatory bowel disease – Newswise

Inflammatory bowel disease (IBD) includes Crohns disease and ulcerative colitis and is an idiopathic, chronic inflammatory disease of the colonic mucosa. The occurrence of IBD, causes irreversible damage to the colon and increases the risk of carcinoma. The routine clinical treatment of IBD includes drug treatment, endoscopic treatment and surgery. The vast majority of patients are treated with drugs and biological agents, but the complete cure of IBD is difficult. Mesenchymal stem cells (MSCs) have become a new type of cell therapy for the treatment of IBD due to their immunomodulatory and nutritional functions, which have been confirmed in many clinical trials. This review discusses some potential mechanisms of MSCs in the treatment of IBD, summarizes the experimental results, and provides new insights to enhance the therapeutic effects of MSCs in future applications.

Core Tip: Mesenchymal stem cell (MSC) transplantation is a novel treatment method for inflammatory bowel disease (IBD) that has exhibits certain achievements in clinical trials. Here, we reviewed the developed strategies for enhancing the therapeutic effect of MSCs, and among these, pretreatment with MSCs is the most common method. The pretreatments include bioactive substances, hypoxia and modification of culture methods and are able to enhance the migration ability of MSCs to repair the damaged intestinal mucosa or upregulate the expression of cytokines. These methods provide new ideas for the future clinical application of MSCs in the treatment of IBD.

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Strategies to improve the effect of mesenchymal stem cell therapy on inflammatory bowel disease - Newswise