The Stem Cell Therapy market study Added by Affluence Market Reports, provides an in-depth analysis pertaining to potential drivers fueling this industry. The research report on the Stem Cell Therapy market consists of significant information regarding the growth drivers, opportunities, and the challenges & restraints that define the business scenario in the subsequent years.

The report offers valuable insight into the Stem Cell Therapy market progress and approaches related to the Stem Cell Therapy market with an analysis of each region. The report goes on to talk about the dominant aspects of the market and examine each segment

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Key Players:

The global Stem Cell Therapy market has been comprehensively analyzed and the different companies that occupy a large percentage of the market share in the regions mentioned have been listed out in the report. Industry trends that are popular and are causing a resurgence in the market growth are identified. A strategic profile of the companies is also carried out to identify the various subsidiaries that they own in the different regions and who are responsible for daily operations in these regions.

The Key Players Covered in Stem Cell Therapy Market Study are:

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Stem Cell Therapy Market Segmentation:

Stem Cell Therapy market is split by Type and by Application. For the period 2018-2025, the growth among segments provides accurate calculations and forecasts for sales by Type and by Application in terms of volume and value. This analysis can help you expand your business by targeting qualified niche markets.

Market Segmentation by Type:

Market Segmentation by Applications:

Impact of COVID-19 on Stem Cell Therapy Market

The report also contains the effect of the ongoing worldwide pandemic, i.e., COVID-19, on the Stem Cell Therapy Market and what the future holds for it. It offers an analysis of the impacts of the epidemic on the international market. The epidemic has immediately interrupted the requirement and supply series. The Stem Cell Therapy Market report also assesses the economic effect on firms and monetary markets. Futuristic Reports has accumulated advice from several delegates of this business and has engaged from the secondary and primary research to extend the customers with strategies and data to combat industry struggles throughout and after the COVID-19 pandemic.

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Regional Analysis Covered in this Report are:

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Stem Cell Therapy Market 2020: Potential Growth, Challenges, and Know the Companies List Could Potentially Benefit or Loose out From the Impact of...

Share This Article:Embryonic stem cells. Image by Prue Talbot / UC RiversideBy Dr. Larry Goldstein

A yes vote on Proposition 14 is crucial to continue the pace of medical research and our states journey to save lives. For millions of Californians who live with a chronic disease or condition, and who need new therapies, this may be their last hope. Advancing medical progress to fight devastating and life-threatening diseases and conditions is an urgent matter now.

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Proposition 14 will continue funding for the California Institute for Regenerative Medicine, the states stem cell research funding institute. This institute is advancing medical discoveries and treatments for dozens of life-threatening or chronic diseases and conditions, including cancer, diabetes, heart disease, Alzheimers, Parkinsons, COVID-19 and more.

It is important to understand that the federal government and the private sector wont adequately fund the development of many important stem cell therapies. While the federal government has a strong focus on early lab research, it has also effectively banned funding of many important types of stem cell research and is threatening to ban more. On the other end, private funders have different priorities when it comes to funding medical research they almost exclusively invest in late-stage clinical trials where they can profit faster at lower financial risk.

There is a glaring funding gap between early lab work and late-stage clinical trials known as The Valley of Death that often ends promising stem cell research. With the sole mission of advancing the most promising treatments and cures, the institute bridges this critical gap, ensuring that potential life-changing therapies are not left stranded. The institutes unique approach is driving our state to achieve more progress, much faster, than we could have imagined.

The institutes funding has catalyzed or funded more than 90 clinical trials, two FDA-approved cancer treatments, and nine new treatments that have been designated as breakthrough therapies and have been fast-tracked for FDA approval. These breakthroughs will potentially help patients with cancer, diabetes, kidney disease, blindness, spinal cord injuries and immunodeficiencies.

While most of the 90+ clinical trials are still underway, many lives appear to have already been saved or improved. Babies born without immune systems are now surviving as are cancer patients who have exhausted all other treatment options. The institute has funded projects to help patients with Type I Diabetes produce their own insulin, blind patients start to regain eyesight, and quadriplegics start to regain upper body function.

All of these treatments in the pipeline if and when approved will also lead to spin-off treatments because they are fundamentally changing our knowledge and approach to treating chronic diseases. For example, by saving the lives of babies born with fatal immune disorders, the new knowledge and technologies are now being applied to treat other types of disorders. Cancer therapies being developed are effectively treating a handful of cancers today, but the knowledge and technology created can be applied to treating many other forms of cancer.

If Californians do not pass Proposition 14, our journey ends here many discoveries could be left on the shelf, delaying lifesaving and life-changing treatments for years.

Furthermore, as our state recovers from the impacts of COVID-19, Proposition 14 will provide an economic stimulus it will generate additional tax revenue and create many new jobs, and it wont cost the state anything until 2026. At a time when the cost of treating chronic diseases is straining our state budget and California families, Proposition 14 seeks to fund crucial disease research at a cost of less than a fraction of 1% of what Californians spend on chronic disease annually.

Close to 100 patient advocate organizations, major chambers of commerce across the state, Gov. Gavin Newsom, federal, state and local elected officials and the University of California Regents support Proposition 14. They do so because of its promise for therapy development, new business creation, and long-term financial benefit to all Californians.

We should remember that one of Californias core strengths is innovation and creation new types of businesses, new types of scientific research, and new ways to treat chronic diseases, conditions and illnesses. We cant afford to turn our back on these important goals. Our future depends on it. I hope you join me in voting YES on Proposition 14.

Dr. Larry Goldstein is a distinguished professor on the staff of the Shiley-Marcos Alzheimers Disease Research Centerat UC San Diego.

Opinion: Proposition 14 Could Save the Life of Someone You Love was last modified: October 31st, 2020 by Editor

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Opinion: Proposition 14 Could Save the Life of Someone You Love - Times of San Diego

Ending Disease, a forthcoming documentary directed by Emmy award-winning filmmaker Joe Gantz, explores the controversial world of stem cell researchand why it's on the frontlines of combatting incurable disease.

The four-part series follows 10 patients who suffer from debilitating illnesses including paralysis, blindness, and terminal cancer. Each patient participated in the first FDA-approved clinical trials using stem cell and CAR T-cell therapy to treat conditions that were previously deemed incurable.

Stem cells are cells with the ability to develop into other cells, allowing them to repair damaged areas of the body. Stem cell therapy, also known as regenerative medicine, involves using these cells to heal diseased, injured, or dysfunctional tissue. CAR T-cell therapy, on the other hand, is a form of immunotherapy in which a patient's T cells are collected from the blood and modified into chimeric antigen receptors (CARs).

In this exclusive Ending Disease trailer, a high school senior becomes paralyzed after suffering a neck injury during a basketball game. His parents view stem cell therapy as their son's only option to recovery:

Another woman learns that her cancer has returned, after an MRI shows lesions on her breast and lungs. "It seemed like it was a death sentence," she says in the video, and then she begins the process of CAR T-cell therapy.

"I became legally blind when I was 26; this could potentially restore my vision," a second woman shares of the revolutionary clinical trial.

Later, the documentary shows the teenage boy regaining his strength in a wheelchair, while the formerly blind woman goes rock climbing. The woman with cancer is seen playing soccer with young children.

"We have in our own bodies the cells that know how to regenerate our own bodies, so this is a real medical revolution," a healthcare worker says.

The documentary promises to be an exciting look at an ambitious clinical trial that aims to change lives for the better. Ending Disease is set to release on Friday, November 13.

You can catch a virtual screening by purchasing tickets at one of the following local participating cinemas: Gathr Films, Laemmle Virtual Cinema (Los Angeles, C.A.), The Lark (Marin County, C.A.), Tampa Theater (Tampa, F.L.), Grail Movie House (Asheville, N.C.), Cinema Art Theater (Lewes, D.E.), Real Art Ways (Hartford, C.T.), The Neon (Dayton, O.H.), Oxford Film Society (Oxford, M.S.).

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Exclusive: "Ending Disease" Documentary Explores How Stem Cell Therapy Aims to Cure the Incurable - Prevention.com

Ongoing studies of Cynata Therapeutics Cymerus stem cell products are beginning to reveal a wide range of commercial possibilities for the ASX-listed companys cutting edge biotechnology that it is looking to apply to a multitude of ailments from the treatment of osteoarthritis and heart attacks through to COVID-19.

In its most advanced trials to date, Cynata will soon embark on a Phase 3 trial of its CYP-004 product, the companys mesenchymal stem cell or MSC product developed to treat osteoarthritis. The 448 person trial is being sponsored by The University of Sydney and will be funded by a project grant from the Australian Government National Health and Medical Research Council.

The company is also progressing on multiple other fronts developing a range of Cymerus MSC therapeutics with the CYP-001 product being another lead candidate. CYP-001 is being developed to treat acute graft-versus-host disease, or GVHD an affliction suffered by bone marrow transplant recipients. GVHD can develop from donated bone marrow that does not take well to a recipients body which triggers an immune response, attacking the host.

Presently, GVHD is treated with steroid therapy however sufferers tend to have a very low survival rate, with less than 20 per cent of patients living for more than two years and few alternate treatment pathways are available.

This looks set to change following Phase 1 trial of Cynatas CYP-001 product on a cohort of patients which saw the survival rate of sufferers of GVHD triple to 60 per cent over a two-year period. The company is now moving CYP-001 into Phase 2 testing and towards commercialisation with partner and shareholder, Fujifilm Corporation.

The matchup with the Japanese-based multi-national is already paying dividends with Cynata receiving an upfront US$3 million payment with further staged payments and royalties to follow in a licensing deal potentially worth more than US$50 million in the longer term.

Stem cells are the building blocks of the human body - essentially the cells from which all other cells are derived and under the right conditions, they can divide to produce more cells sometimes known as Daughter cells. These Daughter cells can become new stem cells or more specialised cells such as blood, bone or even the cells that make up brain or heart tissue.

When appropriately manipulated, stem cells have the potential to treat a range of diseases and aid in the healing and recovery of patients suffering both disease and trauma.

There are a limited number of sources of stem cells - embryonic stem cells, perinatal stem cells and adult stem cells.

Embryonic stem cells are thought to be the most useful and versatile but only harvestable in very small quantities. Perinatal stem cells found in amniotic fluid and umbilical cord blood are also only harvestable in limited quantities although their potential is yet to be fully understood.

Adult stem cells, found in bone marrow or fat, were previously thought to be only useful in producing a limited range of specialised cells with multiple donors required to generate practical amounts of therapeutical medicines.

However, ongoing research shows that by utilising a form of genetic reprogramming, mature cells can be re-programmed to behave like embryonic stem cells. These manipulated cells are called induced pluripotent stem cells, or iPSCs which is where Cynatas Cymerus technology comes into the picture.

Cynatas proprietary Cymerus technology uses iPSCs and a precursor cell called a mesenchymoangioblast to manufacture MSC therapies at a commercial scale without the need for multiple donors. This is where the Cymerus platform diverges from similar therapies, doing away with the need for multiple donors and overcoming a bottleneck in the generation of its product.

Other Cynata MSC products in development include a therapy to assist in the treatment and recovery of heart attacks, which is also showing promise according to the company. Another Cynata product undergoing pre-clinical trials with potential application in the treatment of lung disease is idiopathic pulmonary fibrosis, or IPF. Cynatas research in lung diseases has an unexpected spin-off in that its MSCs may assist in a patients recovery of COVID-19 according to the company. This application is being pursued in a clinical trial in COVID-19 patients presently being conducted in NSW.

These latest results with Cymerus MSCs add to the large body of evidence on the potency of these cells and their potential utility in treating a wide range of devastating diseases. IPF represents an enormous unmet medical need, as existing treatment options have only modest effects on disease progression and survival rates.

Cynatas is now modelling potential MSC therapies to treat various other afflictions too including critical limb ischemia, asthma, sepsis, cytokine release syndrome and diabetic wounds.

In the world of biotechnology, you really only have to produce one winner to attract a longing stare from the big biotechs who can swallow you whole with their massive cheque books with a range of targets and opportunities in its armoury that look to be developing well, dont be surprised if Cynata eventually disappears under the giant footprint of one of the big biotechs.

Is your ASX listed company doing something interesting? Contact: matt.birney@wanews.com.au

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Cynata looking to revolutionise stem cell therapy - The West Australian

Global Stem Cell Therapy Market Overview:

The report includes background information along with a detailed overview of the global Stem Cell Therapy market. This data explains the development of the Stem Cell Therapy market as well as technological advances. The report also covers various end-user applications in the Stem Cell Therapy market. The market has been divided into several segments based on specific data that represents the total market share by the forecast year 2025. In addition, the Stem Cell Therapy market data is derived from competitive partners, key players and their revenues over the years. It also includes data on numerous players from all over the world, leading to huge fragmentation of the global Stem Cell Therapy market. The forecast for 2020-2025 highlights the growth of the Stem Cell Therapy market in terms of CAGR.

The impact of the Covid-19 outbreak on the Stem Cell Therapy industry, including potential opportunities and challenges, driving forces and risks, is also explored and evaluated in this study. Based on various scenarios (optimistic, pessimistic, very optimistic, most likely, etc.), we present an estimate of the impact of Covid-19 on a Stem Cell Therapy writer and a forecast for market growth for 2020-2025.

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Global Stem Cell Therapy Market Research analyzes vital geographic regions, provides a detailed assessment, including key market trends in accordance with their growth, future technologies, industry drivers, problems, regulatory policies, profiles of key players.

The research process included the study of various factors affecting the Stem Cell Therapy industry, including government policy, market environment, competitive environment, historical data, key technological advances and current trends shaping the market, current market trends and technological progress in related industries, and market risks, opportunities, market barriers and challenges.

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Competitive Analysis:

Major players place great emphasis on technological innovation to improve efficiency levels. The industrys growth prospects are reflected in ensuring continual improvement in player processes and optimal strategies used by companies to combat the COVID-19 situation. The company profile section of players such as Marriott International, Hilton Worldwide and AccorHotels includes relevant information such as name, subsidiaries, website, headquarters, market position, market growth / bust, historical background or comments on growth, as well as the top 3 closest competitors by market capitalization. / income along with contact information. Each companys revenues, annual growth, gross and operating margins are presented in an easy-to-understand tabular format over the past 5 years and in a separate section on recent events such as mergers and acquisitions, patent approvals, new project launches, etc.

Stem Cell Therapy Market Segmentation

By Types:

Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCsBone Marrow-Derived Mesenchymal SCsEmbryonic SCsOther Sources

By Applications:

Based on therapeutic application, the market has been segmented into,

Musculoskeletal DisordersWounds & InjuriesCardiovascular DiseasesGastrointestinal DiseasesImmune System DiseasesOther Applications

Research Methodology

The Global Stem Cell Therapy Market Research was conducted by a team of industry experts and professionals with deep market knowledge. Researchers determine the intensity of competition and also study the opportunities for growth in the market using the parameters of the Porters five forces model method. The report also conducts a SWOT analysis of the Stem Cell Therapy market, identifying strengths, weaknesses, opportunities and threats in the market. The report will help companies entering the market get a complete picture of current and future market trends.

Market Dynamics

This report explores various market factors driving the rapid growth and expansion of the Stem Cell Therapy market. The report includes a detailed study of the history of pricing, supply and demand dynamics, price trends, etc., which play a huge role in the market. The report also examines the impact of government initiatives and policies on market stability. The report also analyzes market opportunities and weaknesses, which can help companies develop appropriate strategies.

Some of the major objectives of this report:

1. To provide a detailed analysis of the market structure along with the forecast of the various segments and sub-segments of the global Stem Cell Therapy Market.2. To provide insights about factors affecting market growth. To analyze the Stem Cell Therapy Market based on various factors- price analysis, supply chain analysis, porter five force analyses, etc.3. To provide historical and forecast revenue of the Stem Cell Therapy Market segments and sub-segments with respect to four main geographies and their countries- North America, Europe, Asia, and the Rest of the World.4. Country-level analysis of the market with respect to the current market size and future prospective.5. To provide country-level analysis of the market for segment by application, product type, and sub-segments.6. To provide strategic profiling of key players in the market, comprehensively analyzing their core competencies, and drawing a competitive landscape for the market.7. Track and analyze competitive developments such as joint ventures, strategic alliances, mergers and acquisitions, new product developments, and research and developments in the Stem Cell Therapy Market.

Table of Contents: Stem Cell Therapy Market

Chapter 1. Stem Cell Therapy Market OverviewChapter 2: State of the World Market and Forecasts by RegionChapter 3: State of the World Market and Forecast by TypeChapter 4: Global Market State and Prospects for the Downstream SectorsChapter 5: Analyzing Market DriversChapter 6: The State of Market Competition of Major ProducersChapter 7: Major Producers and Market DataChapter 8: Exploration and Production Market AnalysisChapter 9: Cost and Gross Profit AnalysisChapter 10: Analyzing Marketing StatusChapter 11: Conclusion of the Market ReportChapter 12: Research Methodology and Background Information

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Stem Cell Therapy Market Size 2020 Growth Analysis and Share by Key Players, Trends with Revenue with COVID-19 Impact Forecast to 2026 - PRnews...

The global stem cell and regenerative medicines market should grow from $21.8 billion in 2019 to reach $55.0 billion by 2024 at a compound annual growth rate (CAGR) of 20.4% for the period of 2019-2024.

Report Scope:

The scope of this report is broad and covers various type of product available in the stem cell and regenerative medicines market and potential application sectors across various industries. The current report offers a detailed analysis of the stem cell and regenerative medicines market.

The report highlights the current and future market potential of stem cell and regenerative medicines and provides a detailed analysis of the competitive environment, recent development, merger and acquisition, drivers, restraints, and technology background in the market. The report also covers market projections through 2024.

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The report details market shares of stem cell and regenerative medicines based on products, application, and geography. Based on product the market is segmented into therapeutic products, cell banking, tools and reagents. The therapeutics products segments include cell therapy, tissue engineering and gene therapy. By application, the market is segmented into oncology, cardiovascular disorders, dermatology, orthopedic applications, central nervous system disorders, diabetes, others

The market is segmented by geography into the following regions: North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The report presents detailed analyses of major countries such as the U.S., Canada, Mexico, Germany, the U.K. France, Japan, China and India. For market estimates, data is provided for 2018 as the base year, with forecasts for 2019 through 2024. Estimated values are based on product manufacturers total revenues. Projected and forecasted revenue values are in constant U.S. dollars, unadjusted for inflation.

Report Includes:

28 data tables An overview of global markets for stem cell and regenerative medicines Analyses of global market trends, with data from 2018, estimates for 2019, and projections of compound annual growth rates (CAGRs) through 2024 Details of historic background and description of embryonic and adult stem cells Information on stem cell banking and stem cell research A look at the growing research & development activities in regenerative medicine Coverage of ethical issues in stem cell research & regulatory constraints on biopharmaceuticals Comprehensive company profiles of key players in the market, including Aldagen Inc., Caladrius Biosciences Inc., Daiichi Sankyo Co. Ltd., Gamida Cell Ltd. and Novartis AG

Summary

The global market for stem cell and regenerative medicines was valued at REDACTED billion in 2018. The market is expected to grow at a compound annual growth rate (CAGR) of REDACTED to reach approximately REDACTED billion by 2024. Growth of the global market is attributed to the factors such as growingprevalence of cancer, technological advancement in product, growing adoption of novel therapeuticssuch as cell therapy, gene therapy in treatment of chronic diseases and increasing investment fromprivate players in cell-based therapies.

In the global market, North America held the highest market share in 2018. The Asia-Pacific region is anticipated to grow at the highest CAGR during the forecast period. The growing government funding for regenerative medicines in research institutes along with the growing number of clinical trials based on cell-based therapy and investment in R&D activities is expected to supplement the growth of the stem cell and regenerative market in Asia-Pacific region during the forecast period.

Reasons for Doing This Study

Global stem cell and regenerative medicines market comprises of various products for novel therapeutics that are adopted across various applications. New advancement and product launches have influenced the stem cell and regenerative medicines market and it is expected to grow in the near future. The biopharmaceutical companies are investing significantly in cell-based therapeutics. The government organizations are funding research and development activities related to stem cell research. These factors are impacting the stem cell and regenerative medicines market positively and augmenting the demand of stem cell and regenerative therapy among different application segments. The market is impacted through adoption of stem cell therapy. The key players in the market are investing in development of innovative products. The stem cell therapy market is likely to grow during the forecast period owing to growing investment from private companies, increasing in regulatory approval of stem cell-based therapeutics for treatment of chronic diseases and growth in commercial applications of regenerative medicine.

Products based on stem cells do not yet form an established market, but unlike some other potential applications of bioscience, stem cell technology has already produced many significant products in important therapeutic areas. The potential scope of the stem cell market is now becoming clear, and it is appropriate to review the technology, see its current practical applications, evaluate the participating companies and look to its future.

The report provides the reader with a background on stem cell and regenerative therapy, analyzes the current factors influencing the market, provides decision-makers the tools that inform decisions about expansion and penetration in this market.

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Stem Cell and Regenerative Therapy Market to Remain Balanced During the the COVID-19 Period - re:Jerusalem

Global Canine Stem Cell TherapyMarket 2020-2026 Key Challenges. Industry Risks and Worldwide Opportunities during Covid-19.

Market Research Vision published latest Research Report on Global Canine Stem Cell TherapyMarket 2020. Research study explores economical impact of pandemic on Canine Stem Cell Therapyindustry Segment as follows:

By Important Manufacturers Aratana Therapeutics, Okyanos, Magellan Stem Cells, Stem Cell Vet, VetStem Biopharma, Medrego, Regeneus Ltd, MediVet Biologic, Cell Therapy Sciences

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The report has segmented market 20202026 into different components on the basis of products, Application, geography and end users wherever needed. With thorough analysis and detailed study of past, present and future market 20202026 conditions, the report is able to delivery factual and reliable information to the users.

By Region / Countries

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Our Research Experts have made this insightful report on Canine Stem Cell Therapymarket, which is available for user on the site of Market Research Vision. The report carries various factors and elements of the industry in picture, all around the globe, be it its potential or probable threat to its growth or simply the way and method of its functioning during covid-19.

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In-Depth Report on Canine Stem Cell Therapy Market 2020|by Top Key players Aratana Therapeutics, Okyanos, Magellan Stem Cells, Stem Cell Vet - The...

The FDA has lifted the clinical hold placed on the phase 1 PSMA-101-001 study (NCT04249947) of the CAR T-cell therapy P-PSMA-101 in patients with metastatic castration-resistant prostate cancer (mCRPC), according to Poseida Therapeutics, Inc, the drug developer.1

The company announced plans to resume the trial immediately, noting that they have agreed to make amendments to the protocol in an effort to increase patient compliance and safety. Some of these modifications are with regard to study inclusion and exclusion criteria, as well as frequency of monitoring and laboratory testing.

In August 2020, the regulatory agency made the decision to place a clinical hold on the trial examining P-PSMA-101 after a notification of a patient death had been issued by the company.2 The patient, who had reportedly progressed on many anticancer agents prior to receiving the CAR T-cell therapy in late July 2020, had normal laboratory results after the first week of treatment; the patient did not showcase any clinical symptoms suggestive of an adverse effect, according to the company.

Despite this, the patient missed his follow-up visits that were scheduled for day 10 and day 14 following treatment with the product. During that time span, he reportedly presented with symptoms that resulted in hospitalization. On day 19, the patient experienced hepatic failure and died.

At the time of the report, the cause of the hepatic failure had not been confirmed, although the patient experienced symptoms that proved to be consistent with macrophage activation syndrome (MAS). It is known, however, that MAS can be caused by other events beyond treatment with CAR T-cell therapy, such as autoimmune disease or infection.

Moreover, the patient developed blurred vision and was diagnosed with uveitis, according to the company. The toxicity was determined to potentially be linked with P-PSMA-101 per investigator assessment, although the company announced that they would be looking into this further.

No other participants enrolled to the study experienced severe toxicities of reduced vision, uveitis, MAS, or hepatic failure. Moreover, no patients reported cytokine release syndrome or neurotoxicity with the product.

Designed to target prostate-specific membrane antigen, P-PSMA-101 was developed using Poseidas piggyBac DNA Modification System, which produces agents with a high percentage of stem cell memory cells.3 These cells are able to reconstruct T-cell subsets, such as effecter T cells, which play a key role in eliminating cancer cells. Additionally, the higher composition of stem cell memory cells is hypothesized to be able to potentially overcome challenges associated with earlier-generation CAR T-cell therapies, according to the company.

The open-label, multicenter, dose-escalating phase 1 trial was designed to identify the optimal dose of the CAR T-cell product for safe administration in patients with mCRPC.4 Patients had to have metastatic disease that continued to grow despite prior treatment for advanced CRPC in order to participate. Moreover, they had to have recovered from any serious toxicities that occurred from previous treatment. If they had acceptable organ function with predetermined parameters and an ECOG performance status ranging from 0 to 1, they were eligible for inclusion.5

However, if patients had unacceptable venous access and/or contraindications to leukapheresis or they had an active second malignancy beyond mCRPC, active autoimmune disease, a history of significant central nervous system disease, or an active systemic infection, they could not participate. If they had received anticancer medications within 2 weeks of conditioning chemotherapy, immunosuppressive treatment within 2 weeks of initiating leukapheresis, or systemic corticosteroid therapy in that time, they were not permitted.

The primary end point of the trial is safety, establishing the maximum-tolerated dose, and efficacy. In the trial, patients were given either single or multiple doses of P-PSMA-101; the first participant received treatment with the CAR T-cell product on May 20, 2020.

Read more from the original source:
FDA Lifts Hold on Phase 1 Trial of CAR T-Cell Therapy P-PSMA-101 in mCRPC - OncLive

Fremont, CA , Oct. 28, 2020 (GLOBE NEWSWIRE) -- APstem Therapeutics, Inc., a private biopharmaceutical company developing breakthrough stem cell therapies, today announced the completion of an INitial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) meeting with the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT). The meeting, which included CBER OTAT staff together with the APstem team, focused on the development plan for AP-Skin-01, a novel off-the-shelf allogeneic stem cell product derived from adult pluripotent stem cells (APSCs) for the initial treatment of diabetic ulcers.

Previous efforts to treat diabetic ulcers have been hampered by persistent inflammation, ischemia and delayed re-epithelialization, which together have posed an insurmountable challenge for drug developers. APstems proprietary stem cell technologies and unique attributes of APSCs may circumvent these obstacles. Preclinical results generated to date by APstem support the potential of AP-Skin-01 to treat difficult-to-heal diabetic ulcers by accelerating healing. AP-Skin-01 is designed to provide full skin structural reconstruction with less scar formation, promote angiogenesis and reduce inflammation during the repair process.

The INTERACT meeting we conducted with the FDA is an important first step in our development of AP-Skin-01. We considered the meeting to be very successful, with productive feedback from the FDA reviewers and strong alignment of APstems development approach for AP-Skin-01, said Dr. Min Hu, CEO and president of APstem Therapeutics. I would like to thank the reviewers from FDA CBER OTAT for their time and helpful guidance. We look forward to continuing our planned pre-clinical work into 2021.

Dr. Jane Lebkowski, APstems scientific advisor and an expert in the development of cell and gene therapies, added: The field of chronic diabetic wounds remains a critical unmet medical need in the expanding diabetic population worldwide. This new therapy has high potential to accelerate full skin regeneration. Therefore, we are grateful for FDAs positive feedback to accelerate the development of this product that could treat millions of patients.

INTERACT is the first available FDA interaction and is a key step in the pathway towards an Investigational New Drug (IND) application, the first regulatory step before experimental therapies may be tested in human clinical studies.

About APstem Therapeutics, Inc.

APstem Therapeutics is a biopharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing novel stem cell therapies. APstems breakthrough stem cell therapy platform using our unique APSCs can be applied to multiple indications, including skin (diabetic ulcers), liver, lungs, bone/cartilage, heart, neuron and other tissues. For more information, please visit http://www.apstemtx.com.

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APstem Therapeutics Announces Successful FDA INTERACT Meeting Regarding AP-Skin-01, an Off-the-Shelf Allogeneic Stem Cell Product for the Treatment of...

Global Stem Cell Therapy Market Status (2015-2019) and Forecast (2020-2025) by Region, Product Type & End-Use

The Global Intelligence Insights added a new report Global Stem Cell Therapy Market: Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2020 2025 in its database, which provides an expert and in-depth analysis of key business trends and future market development prospects, key drivers and restraints, profiles of major market players, segmentation and forecasting.

Market Overview:

Stem cell therapy market size was valued at USD 7.8 billion in 2018 and is expected to witness 10.2% CAGR from 2019 to 2025.

The global Stem Cell Therapy Market report offers a complete overview of the Stem Cell Therapy Market globally. It presents real data and statistics on the inclinations and improvements in global Stem Cell Therapy Markets. It also highlights manufacturing, abilities & technologies, and unstable structure of the market. The global Stem Cell Therapy Market report elaborates the crucial data along with all important insights related to the current market status.

The report additionally provides a pest analysis of all five along with the SWOT analysis for all companies profiled in the report. The report also consists of various company profiles and their key players; it also includes the competitive scenario, opportunities, and market of geographic regions. The regional outlook on the Stem Cell Therapy market covers areas such as Europe, Asia, China, India, North America, and the rest of the globe.

Note In order to provide more accurate market forecast, all our reports will be updated before delivery by considering the impact of COVID-19.

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Top Key Players: Osiris Therapeutics, Inc. (US), MEDIPOST Co., Ltd. (South Korea), Anterogen Co., Ltd. (South Korea), Pharmicell Co., Ltd. (South Korea), Holostem Terapie Avanzate S.r.l. (Italy), JCR Pharmaceuticals Co., Ltd. (Japan), NuVasive, Inc. (US), RTI Surgical, Inc. (US), and AlloSource (US), Thermo Fisher Scientific

The main goal for the dissemination of this information is to give a descriptive analysis of how the trends could potentially affect the upcoming future of Stem Cell Therapy market during the forecast period. This markets competitive manufactures and the upcoming manufactures are studied with their detailed research. Revenue, production, price, market share of these players is mentioned with precise information.

Market Dynamics:

The report analyzes the factors impacting the growth and the current market trends influencing the global Stem Cell Therapy market. Detailed pricing information with ex-factory prices of various products by key manufacturers form a crucial part of the report. Competition analysis, along with regional government policies affecting the Stem Cell Therapy market provides a detailed overview of the current status and prospects of the market. The impact of the ever-growing global population, coupled with technological advancements affecting the global Stem Cell Therapy market is also covered in the report.

Drivers & Constraints:

The report provides extensive information about the factors driving the global Stem Cell Therapy market. Factors influencing the growth of the Stem Cell Therapy market, along with technological advancements, are discussed extensively in the report. The current restraints of the market, limiting the growth and their future impact are also analyzed in the report. The report also discusses the impact of rising consumer demand, along with global economic growth on the Stem Cell Therapy market.

Regional Segment Analysis:

This report provides pinpoint analysis for changing competitive dynamics. It offers a forward-looking perspective on different factors driving or limiting market growth. It provides a five-year forecast assessed on the basis of how they Stem Cell Therapy Market is predicted to grow. It helps in understanding the key product segments and their future and helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments.

Key questions answered in the report include:

What will the market size and the growth rate be in 2025?

What are the key factors driving the Global Stem Cell Therapy Market?

What are the key market trends impacting the growth of the Global Stem Cell Therapy Market?

What are the challenges to market growth?

Who are the key vendors in the Global Stem Cell Therapy Market?

What are the market opportunities and threats faced by the vendors in the Global Stem Cell Therapy Market?

Trending factors influencing the market shares of the Americas, APAC, Europe, and MEA.

The report includes six parts, dealing with:

1.) Basic information;

2.) The Asia Stem Cell Therapy Market;

3.) The North American Stem Cell Therapy Market;

4.) The European Stem Cell Therapy Market;

5.) Market entry and investment feasibility;

6.) The report conclusion.

Reasons for Buying this Report:

This report provides pin-point analysis for changing competitive dynamics

It provides a forward looking perspective on different factors driving or restraining market growth

It provides a six-year forecast assessed on the basis of how the market is predicted to grow

It helps in understanding the key product segments and their future

It provides pin point analysis of changing competition dynamics and keeps you ahead of competitors

It helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments

TABLE OF CONTENT:

1 Report Overview

2 Global Growth Trends

3 Market Share by Key Players

4 Breakdown Data by Type and Application

5 United States

6 Europe

7 China

8 Japan

9 Southeast Asia

10 India

11 Central & South America

12 International Players Profiles

13 Market Forecasts 2019-2025

14 Analysts Viewpoints/Conclusions

15 Appendixes

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Stem Cell Therapy Market expected to witness 10.2% CAGR with USD 7.8 billion | Growth Trends, Business Size, Share Report, Key Players and Global...