Category Archives: Stem Cell Medicine

Protalix BioTherapeutics Appoints Yael Hayon, Ph.D. as its New Vice President, Research and Development – BioSpace

CARMIEL,Israel, June 8, 2020 /PRNewswire/ -- Protalix Biotherapeutics, Inc., (NYSE American: PLX) (TASE: PLX) today announced the appointment of Yael Hayon, Ph.D. as the Company's new Vice President, Research and Development, effective July5, 2020. On June 2, 2020, Yoseph Shaaltiel, Ph.D. retired from his position as the Company's Executive Vice President, Research and Development, effective June 15, 2020.

"Yossi's incredible scientific and entrepreneurial vision led to his founding of Protalix," said Zeev Bronfeld, Chairman of Protalix's Board of Directors. "Yossi's efforts resulted in the development of ProCellEx, our proprietary plant cell-based protein expression system which we use to produce taliglucerase alfa, an approved treatment for Gaucher disease, pegunigalsidase alfa, our investigationaltreatment for Fabry disease which is in the latter stages of clinical development and our other investigationaldrug candidates. The Board of Directors and I are immensely grateful to Yossi for his knowledge, leadership, integrity and professionalism in building Protalix from its founding days to where it is today. We wish him all the best in his future endeavors."

"I am delighted that Yael is joining the Protalix team where she will bring valuable and diverse research& development experience and knowledge," said Dror Bashan, Protalix's President and Chief Executive Officer. "We are greatly thankful to Yossi for his exceptional efforts in founding and building Protalix, and wish him great success in the future."

Dr. Hayon brings to the Company over a decade of experience in pharmaceutical researchand development, both in the scientific operations and the administrative functions. She most recently served as Vice President of Clinical Affairs of Syqe Medical Ltd., Tel-Aviv, where she, among other things, established the clinical and medical global strategy, and was responsible for providing strategic input on the regulatory development plan. Prior to her role at Syqe Medical, Dr. Hayon served as the Head of R&D Israeli Site of LogicBio Therapeutics, Inc., Cambridge, Massachusetts, where she managed LogicBio's Israeli-based Research and Development facility and was involved in strategic decision-making. From 2014 through 2016 she served as the R&D Manager, Stem Cell Medicine Ltd., Jerusalem, Israel. Dr. Hayon holds a Ph.D. in Neurobiology/Hematology, and an MS.c. in Neurobiology, both from the Hebrew University Faculty of Medicine, Jerusalem, Israel.

About Protalix BioTherapeutics, Inc.

Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. Protalix was the first company to gain U.S.Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. Protalix's unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner.

Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.

Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human GalactosidaseA protein for the proposed treatment of Fabry disease; OPRX106, an orally-delivered anti-inflammatory treatment; alidornase alfa for the treatment of Cystic Fibrosis; and others. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "expect," "anticipate," "believe," "estimate," "project," "plan," "should" and "intend," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: that the FDA might not grant marketing approval for PRX102 in the currently anticipated timeline or at all and, if approved, whether PRX102 will be commercially successful; failure or delay in the commencement or completion of our preclinical and clinical trials; risks associated with the novel coronavirus disease (COVID19) outbreak, which may adversely impact our business, preclinical studies and clinical trials; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; and other factors described in our filings with the U.S.Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.

Investor ContactChuck Padala, Managing DirectorLifeSci Advisors+1-646-627-8390chuck@lifesciadvisors.com

Media ContactBrian PinkstonLaVoieHealthScience+1-857-588-3347bpinkston@lavoiehealthscience.com

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Protalix BioTherapeutics Appoints Yael Hayon, Ph.D. as its New Vice President, Research and Development - BioSpace

COVID-19 Impact and Recovery Analysis – Hematopoietic Stem Cells Transplantation (HSCT) Market 2020-2024 | Demand for Personalized Medicine to Boost…

LONDON--(BUSINESS WIRE)--Technavio has been monitoring the hematopoietic stem cells transplantation (HSCT) market and it is poised to grow by USD 4.64 billion during 2020-2024, progressing at a CAGR of almost 6% during the forecast period. The report offers an up-to-date analysis regarding the current market scenario, latest trends and drivers, and the overall market environment.

Technavio suggests three forecast scenarios (optimistic, probable, and pessimistic) considering the impact of COVID-19. Request for Technavio's latest reports on directly and indirectly impacted markets. Market estimates include pre- and post-COVID-19 impact on the Hematopoietic Stem Cells Transplantation (HSCT) Market. Download free sample report

The market is fragmented, and the degree of fragmentation will accelerate during the forecast period. AllCells Corp., bluebird bio Inc., FUJIFILM Holdings Corp., Lineage Cell Therapeutics Inc., Lonza Group Ltd., MEDIPOST Co. Ltd., Merck & Co. Inc., Sanofi, Takeda Pharmaceutical Co. Ltd., and ThermoGenesis Holdings Inc. are some of the major market participants. To make the most of the opportunities, market vendors should focus more on the growth prospects in the fast-growing segments, while maintaining their positions in the slow-growing segments.

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Demand for personalized medicine has been instrumental in driving the growth of the market.

Technavio's custom research reports offer detailed insights on the impact of COVID-19 at an industry level, a regional level, and subsequent supply chain operations. This customized report will also help clients keep up with new product launches in direct & indirect COVID-19 related markets, upcoming vaccines and pipeline analysis, and significant developments in vendor operations and government regulations. https://www.technavio.com/report/report/hematopoietic-stem-cells-transplantation-market-industry-analysis

Hematopoietic Stem Cells Transplantation (HSCT) Market 2020-2024: Segmentation

Hematopoietic Stem Cells Transplantation (HSCT) Market is segmented as below:

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Hematopoietic Stem Cells Transplantation (HSCT) Market 2020-2024: Scope

Technavio presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources. The hematopoietic stem cells transplantation (HSCT) market report covers the following areas:

This study identifies the availability of technologically advanced equipment as one of the prime reasons driving the hematopoietic stem cells transplantation (HSCT) market growth during the next few years.

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Hematopoietic Stem Cells Transplantation (HSCT) Market 2020-2024: Key Highlights

Table of Contents:

Executive Summary

Market Landscape

Market Sizing

Five Forces Analysis

Market Segmentation by Type

Customer Landscape

Geographic Landscape

Drivers, Challenges, and Trends

Vendor Landscape

Vendor Analysis

Appendix

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Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavios report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavios comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.

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COVID-19 Impact and Recovery Analysis - Hematopoietic Stem Cells Transplantation (HSCT) Market 2020-2024 | Demand for Personalized Medicine to Boost...

Biobanking Market to reach US $1,801.7 million by 2025 Global Insights on Key Stakeholders, Value Chain Analysis, Growth Drivers, Regulatory…

Dallas, Texas, June 10, 2020 (GLOBE NEWSWIRE) -- The Global Biobanking Market Size 2018, By Specimen Type (Blood Products, Solid Tissue, Cell Lines, Others) Storage Type (Manual Storage, Automated Storage) Application (Regenerative Medicine, Life Science Research, Clinical Research) Region and Forecast 2019 to 2025 study provides an elaborative view of historic, present and forecasted market estimates.

Adroit Market Research report on global biobanking market gives a holistic view of the market from 2015 to 2025, which includes factors such as market drivers, restraints, opportunities and challenges. The market has been studied for historic years from 2015 to 2017, with the base year of estimation as 2018 and forecast from 2019 to 2025. The report covers the current status and future traits of the market at global as well as country level. In addition, the study also assesses the key players based on their product portfolio, geographic footprint, strategic initiatives and overall revenue. Prominent players operating in the global biobanking market have been studied in detail.

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The global biobanking market is projected to reach USD 1,801.7 million by 2025, growing at a CAGR of 5.7%. Increase in population genetics studies, advances in biobanking with ongoing research on stem cells and public opting for its preservation, uptake of personalized medicine, government & private funding to provision regenerative medicine research, and the use of genetic information in food safety, forensics, and disease surveillance are the factors driving the growth of the biobanking market.

Biobanks consists of human tissues, DNA, body fluids, for research, therapeutic uses, and biological applications. The demand for biobanks and tissue suppliers have grown exponentially in both numbers and size, and are now established key partners for both academic and commercial groups. A recent study of 456 biobanks in the US showed that nearly two thirds of the biobanks were established within the last decade and 17% have been in existence for over 20 years, with 88% of these part of at least one or more larger organizations (67% academic, 23% hospitals, and 13% research institutes). To sustain this level of growth, biobanks have had to understand and satisfy the different interests of their customers in a sustainable method for long-term success. This move away from repository-like organizations and archive libraries is also evident in the level of donor information that is now collected with samples.

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Biobanks catalogue samples using donor demographics such as age, gender, and ethnicity and may also have information on medical history, genetic traits, environmental factors, and follow-up information. To researchers, this information has become as important as the sample itself and is often a key requirement when sourcing material.

The global biobanking market is categorized based on sample type, storage type and application. Based on storage type the market is segmented into manual storage and automated storage. Manual storage held the largest market share in 2018, while the automated storage segment is likely to grow at the highest CAGR during the forecast period. The benefits of automated storage over manual storage include, reduced labor requirements and costs, improved floor space utilization, increased picking accuracy (reduced picking errors), tighter inventory control, improved picking throughput (speed), and improved ergonomics.

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In 2018, North America was the largest market for biobanking. Advances in biomedical, pharmaceutical, and biotechnology industries are some of the factors propelling market growth in this region. Key players of the biobanking market include Thermo Fisher Scientific Inc., Tecan Group Ltd., Qiagen N.V., Hamilton Company, Brooks Automation, TTP Labtech Ltd., VWR Corporation, Promega Corporation, Worthington Industries, Chart Industries, Becton, Dickinson and Company, Merck KGaA and Micronic among others.

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Major points from Table of Contents:1. Introduction2. Research Methodology3. Market Outlook4. Biobanking Market by Specimen Type, 2015-2025 (USD Million)5. Biobanking Market by Storage Type, 2015-2025 (USD Million)6. Biobanking Market by Application, 2015-2025 (USD Million) 7. Biobanking Market by Region 2015-2025 (USD Million)8. Competitive Landscape9. Company Profiles10. Appendix

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Biobanking Market to reach US $1,801.7 million by 2025 Global Insights on Key Stakeholders, Value Chain Analysis, Growth Drivers, Regulatory...

Senolytic drugs: can this antibiotic treat symptoms of ageing? – Health Europa

Professor Michael P Lisanti, Chair in Translational Medicine at the University of Salford, has been an active research scientist for more than 30 years and is an expert in the field of cellular senescence. In 2018 Lisanti, along with his wife and research partner Professor Federica Sotgia, co-authored a paper entitled Azithromycin and Roxithromycin define a new family of senolytic drugs that target senescent human fibroblasts, which identified the FDA-approved antibiotic azithromycin as a senolytic drug: a compound which can be used to treat the symptoms of ageing.

Their research was made possible through generous funding contributions from Lunella Biotech, Inc, a Canadian-based pharmaceutical developer which fosters medical innovation; the Foxpoint Foundation, also based in Canada; and the Healthy Life Foundation, a UK charity which funds research into ageing and age-related conditions. Lisanti speaks to HEQ about his work and the future of senescence studies.

We started out focusing on cancer, but the relationship between cancer and ageing led us to shift our focus towards senescence, the process by which cells chronologically age and go into cell cycle arrest. Senescence leads to chronic inflammation: the cells secrete a lot of inflammatory mediators, which allows the cells to become almost infectious; so then neighbouring normal cells become senescent it has a kind of cataclysmic effect. As you age especially as you approach around 50 you begin to accumulate more senescent cells, which are thought to be the root cause of ageing; this then leads to various ageing-associated diseases, such as heart disease, diabetes, dementia and cancer, the most life threatening conditions in the Western world.

The goal, therefore, would be to remove the senescent cells. It is possible to use a genetic trick to remove senescent cells from mice: this causes them to live longer by preventing ageing-associated diseases; but it is not possible to use the same genetic trick for humans. We would therefore need a drug that only kills or removes senescent cells; and that could then potentially lead to rejuvenation, thereby extending the patients healthy lifespan.

We set up a drug assay using normal, commercially available, human fibroblasts: MRC-5, which comes from the lungs, and BJ-1, which comes from the skin. The idea was to artificially induce ageing, which we did using a compound called BrdU. This compound is a nucleoside: it incorporates into the DNA and that leads to DNA damage; and the DNA damage in turn induces the senescence phenotype. The overarching concept was to create a population of cells artificially that were senescent; and then to compare primary cells that were normal with cells which were senescent, with the goal of identifying drugs which could only selectively kill the senescent cells and not harm the normal cells.

We had previously observed positive results in tests on the metabolic effects of antibiotics, so our drug screening identified two drugs called azithromycin and roxithromycin, which constitute a new family of senolytic drugs. Theyre both clinically approved drugs azithromycin has been around longer; and has a strong safety profile and we looked at other members of the same drug family such as erythromycin, which is the parent compound, but erythromycin has no senolytic activity. The characteristics we were looking for appeared to be relatively restricted to azithromycin, which in our observation was very efficiently killing the senescent cells. As we reported in the paper, it had an efficacy of approximately 97%, meaning that it was able to facilitate the growth of the normal cells, while concurrently selectively killing the senescent cells.

We tested the drug on normal and senescent cells which were otherwise identical. The senescent cells underwent apoptosis programmed cell death so that led us to the conclusion that the drug selectively kills the senescent cells, while at the same time the normal cells are able to continue to proliferate. That selective effect of removing exclusively the senescent cells is what we were searching for; because in this instance we would want a drug that could potentially be used in humans and which would only kill senescent cells.

Obviously, we would have to do clinical trials going forward, but the first step should be to identify the pharmaceutical application. Given that this drug appears to selectively kill and remove the senescent cells, it could be used potentially to prevent ageing-associated disease; and it could therefore potentially extend the human lifespan, especially in terms of reducing diseases and conditions like diabetes, heart disease, dementia and even cancer.

Cystic fibrosis is the most common genetic disease in humans; patients with cystic fibrosis are prone to bacterial lung infections. Researchers started to explore the possibility of using azithromycin preventatively in patients with cystic fibrosis; and they found that, while it didnt necessarily affect patients susceptibility to infection, it did prevent lung fibrosis where the lungs become stiff and the patient is unable to breathe and in doing so, extended the patients lifespan. These studies were focused on myofibroblasts, which at the time werent really seen as senescent; whereas the literature now acknowledges a general consensus that myofibroblasts are indeed senescent cells.

We havent specifically examined anything relating ageing to antimicrobial resistance; but azithromycin is an antibiotic, which is not ideal within the context of AMR. Potentially in the future, once researchers identify what it is about the azithromycin that is causing the senescent cells to die, they could develop future drugs azithromycin is a stepping stone in this context, but what it shows is proof of principle that a drug can be identified which selectively kills senescent cells. This indicates that senescent cells are clearly biochemically distinct from the normal cells, and that it is possible to find a drug that selectively kills them and that is relatively safe. It provides a starting point for further new drug discovery to identify other drugs which might also be selective.

Ideally, we would want a drug which is not an antibiotic; but that means further research will be necessary to find additional drugs or to refine the senolytic activity which weve discovered in this drug. We are in the early stages; the point is that it is experimentally feasible and this would then lend itself to doing new clinical trials in the future, because azithromycin is relatively safe and it probably wont need to be administered over a long period of time to remove senescent cells you might not need to use it for any longer than you would as an antibiotic.

This research has been supported by the Foxpoint Foundation (Canada), the Healthy Life Foundation (UK), and Lunella Biotech, Inc. (Canada).

Professor Michael P Lisanti is Chair of Translational Medicine at the University of Salford School of Science, Engineering & Environment, UK. His current research programme is focused on eradicating cancer stem cells (CSCs); and anti-ageing therapies, in the context of age-associated diseases, such as cancer and dementia.

Lisanti began his education at New York University, US, graduating magna cum laude in chemistry (1985); before completing an MD-PhD in cell biology and genetics at Cornell University Medical College, US (1992). In 1992, he moved to MIT, US, where he worked alongside Nobel laureate David Baltimore and renowned cell biologist Harvey Lodish as a Whitehead Institute fellow (1992-96).

His career has since taken him to the Albert Einstein College of Medicine, US (1997-2006), the Kimmel Cancer Center, US (2006-12), and the University of Manchester, UK (2012-16), where he served as the Muriel Edith Rickman chair of breast oncology, director of the Breakthrough Breast Cancer and the Breast Cancer Now Research Units, and founder and director of the Manchester Centre for Cellular Metabolism.

Lisanti has contributed to 564 publications in peer-reviewed journals and been cited more than 90,000 times. A list of his works can be found at: https://pubmed.ncbi.nlm.nih.gov/?term=lisanti+mp&sort=date

Professor Federica Sotgia currently serves as chair in cancer biology and ageing at the University of Salford School of Science, Engineering and Environment, UK, where she focuses on, inter alia, the role of the tumour microenvironment in cancer and the metabolic requirements of tumour-initiating cells.

Sotgia graduated magna cum laude with an MS in biological sciences (1996) from the University of Genova, Italy, where she later completed a PhD in medical genetics (2001). She moved to the Albert Einstein College of Medicine, US, in 1998, originally as a visiting student and then postdoctoral fellow, and she was appointed an instructor in 2002.

Sotgia has since worked as an assistant professor at the Kimmel Cancer Center, US (2006-12), a senior lecturer at the University of Manchester, UK (2012-16), and a Professor in biomedical science at the University of Salford (2016-present).

She has contributed to 206 publications in peer-reviewed journals and been cited upwards of 27,000 times.

A list of her works can be found at: https://pubmed.ncbi.nlm.nih.gov/?term=sotgia+f&sort=date

Professor Michael P Lisanti, MD-PhD, FRSA, FRSBChair in Translational MedicineSchool of Science, Engineering & EnvironmentUniversity of Salford+44 (0)1612 950 240M.P.Lisanti@salford.ac.uk

This article is from issue 13 of Health Europa. Clickhere to get your free subscription today.

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Senolytic drugs: can this antibiotic treat symptoms of ageing? - Health Europa

Global Regenerative Medicine Market | Industry Outlines, Growth, Trends, In-Depth Analysis And Outlook Till 2026 – Cole of Duty

The global Regenerative Medicine Market is projected to grow with a striking growth rate of 24.2 % over the forecast period 20192026 divulges the latest research report presented by Big Market Research.

The report represents a basic overview of the market status, competitor segment with a basic introduction of key vendors, top regions, product types and end industries. This report gives a historical overview of the market trends, growth, revenue, capacity, cost structure, and key drivers analysis.

The report is an exhaustive analysis of this market across the world. It offers an overview of the market including its definition, applications, key drivers, key market players, key segments, and manufacturing technology. In addition, the study presents statistical data on the status of the market and hence is a valuable source of guidance for companies and individuals interested in the industry. Additionally, detailed insights on the company profile, product specifications, capacity, production value, and market shares for key vendors are presented in the report.

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The total market is further segmented based on company, country, and application/type for competitive landscape analysis. On the contrary, information on industry chain structure, emerging applications, and technological developments in the market makes the report a must-read document.

The report reveals detailed information about the global key players as well as some small players of the Regenerative Medicine sector.

Target Audience of the Global Regenerative Medicine Market in Market Study:Key Consulting Companies & AdvisorsLarge, medium-sized, and small enterprisesVenture capitalistsValue-Added Resellers (VARs)Third-party knowledge providersInvestment bankersInvestors

These insights help determine the strength of competition and take the necessary steps to obtain a leading position in the Regenerative Medicine industry.

Additionally, the research provides a detailed analysis of the key segments of the market with the help of charts and tables. An overview of each market segment such as type, application, and region are also provided in the report. These insights help in understanding the global trends in the Regenerative Medicine industry and form strategies to be implemented in the future.

The regional analysis of global Regenerative Medicine market is considered for the key regions such as Asia Pacific, North America, Europe, Latin America and Rest of the World. North America is the leading/significant region across the world in terms of market share owing to the high disposable income coupled with rising trend of interior designing in the region. Whereas, Asia-Pacific is also anticipated to exhibit highest growth rate / CAGR over the forecast period 2019-2026

Our analysis involves the study of the market taking into consideration the impact of the COVID-19 pandemic. Please get in touch with us to get your hands on exhaustive coverage of the impact of the current situation on the market. Our expert team of analysts will provide as per report customized to your requirement. For more connect with us at [emailprotected] or call toll free: +1-800-910-6452

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Key Market Segments

The key players profiled in this report include: AcelityL.P.Inc., NuvasiveInc., VericelCorporation, OsirisTherapeuticsInc., StrykerCorporation, MedtronicPLC

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values to the coming eight years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within each of the regions and countries involved in the study.

Furthermore, the report also caters the detailed information about the crucial aspects such as driving factors & challenges which will define the future growth of the market. Additionally, the report shall also incorporate available opportunities in micro markets for stakeholders to invest along with the detailed analysis of competitive landscape and product offerings of key players. The detailed segments and sub-segment of the market are explained below:

The key product type of Regenerative Medicine market are: Stem Cell Therapy, Biomaterial, Tissue Engineering, Others

The study clearly reveals that the Regenerative Medicine industry has attained remarkable growth since 2019-2026. This research report is prepared based on an in-depth analysis of the market by experts. As a final point, stakeholders, investors, product managers, marketing executives, and other professionals seeking unbiased data on supply, demand, and future forecasts would find the report valuable.

Table of Contents

Chapter 1. Global Regenerative Medicine Market Definition and ScopeChapter 2. Research MethodologyChapter 3. Executive SummaryChapter 4. Global Regenerative Medicine Market DynamicsChapter 5. Regenerative Medicine Market, by ComponentChapter 6. Global Regenerative Medicine Market, by ServicesChapter 7. Global Regenerative Medicine Market, by Organization SizeChapter 8. Regenerative Medicine Market, by VerticalChapter 9. Regenerative Medicine Market, by Regional AnalysisChapter 10. Competitive Intelligence

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Global Regenerative Medicine Market | Industry Outlines, Growth, Trends, In-Depth Analysis And Outlook Till 2026 - Cole of Duty

Using big data approaches to develop cell therapies – Drug Target Review

An area where stem cell biology and medicine are combining effectively is the establishment of new cell therapies. However, current therapies are limited to a narrow set of cell types that can be isolated or created and expanded in vitro. Dr Owen Rackham discusses how utilising computational approaches will further enhance applications of stem-cell-derived therapies in the future.

For decades (or perhaps centuries) the approach in cell biology has remained relatively unchanged. We isolate cells and with our confined knowledge of their endogenous conditions, begin to experiment until we can sustain them in vitro. Once established, we can conduct further investigation to assess a cells response to different conditions, changes over time or response to manipulation. This is especially true of stem cell biology, established from tireless efforts to incrementally improve culture conditions or differentiation protocols based on fragmented knowledge of developmental processes. Despite this, the promise of stem-cell therapies is already being realised in the clinic, but the breadth of cell types being used is still relatively narrow. Recent technological advances in the field have been focused on the safe and scalable manufacture of therapies. While these are revolutionary breakthroughs, the applications are largely limited to T cells, haematopoietic- and pluripotent-stem cells (HSCs and PSCs), a small fraction in the grand heterogeneity of cell types. Consequently, the lack of cell source diversity prevents cell therapy from fulfilling its clinical potential, pointing to the need for new means to isolate or generate source cells.

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Using big data approaches to develop cell therapies - Drug Target Review

Miracle cures and fast-track approval threatens medical advances, say scientists – The University of Manchester

Prof. Volker ter Meulen, Co-chair of the EASAC-FEAM Working Group and Past President of EASAC, said: Stem cell and gene-based therapies hold great medical promises. But we are alarmed over a trend to lower requirements of evidence. Also, we see an increasing problem of commercial clinics offering unregulated products and services

The Academies say the idea of regenerative medicine is to tackle diseases which up to now are incurable. According to the report, cosmetic applications, for example, are inappropriate for the time being.

So far, regenerative medicine has proven itself only in few specific clinical indications, for example for skin disorders. Yet, we see an increasing number of unregulated clinics promising a wide range of benefits on the basis of poorly characterised medicinal products with little evidence of effectiveness. They usually advertise their services via the internet with the primary intention of financial profit, explains EASAC Biosciences Programme Director Dr. Robin Fears.

The scientists urge the EU to resist the pressure and put patients first. When countries lower regulatory standards in their eagerness to support national economic interests, it is even more important for the EU as a major global player to defend the principles of international cooperation in health regulation, says Prof. George Griffin, Co-chair of the Working Group and President of FEAM.

We all want cures to be available in the shortest time frame possible. But our analysis and recommendations aim at ensuring that regulatory procedures are robust, transparent and evidence-based, concludes Cossu. Scientific research and proof are more important than ever. The EU and national regulators should be wary of not undermining public trust in science.

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Miracle cures and fast-track approval threatens medical advances, say scientists - The University of Manchester

MSC Therapy for Acute Respiratory Distress Syndrome; It’s Time to Accelerate Clinical Trials for COVID-19 Patients in Need – PRNewswire

WASHINGTON, June 3, 2020 /PRNewswire/ --A new systematic review and meta-analysis of clinical studies using mesenchymal stromal cells (MSCs) led by a team at the Mayo Clinic, and including researchers from Emory, Duke, Case-Western, and the University of Miami, shows a trend toward improved outcomes and reduced mortality for patients with acute respiratory distress syndrome (ARDS), a major complication for patients with COVID-19. This studyand several othersalso have shown that MSCs are safe for patients.

Based on these findings, the authors call for the rapid commencement of large-scale, confirmatory clinical trials to build on the existing evidence base, which shows a trend toward improved pulmonary function and reduced severe lung inflammation for patients with ARDS, paving the way toward another treatment option for seriously ill patients with COVID-19.

To date, nearly two million Americans have tested positive for COVID-19 and more than 100,000 Americans have died. In its most severe form, COVID-19 leads to ARDSa life-threatening lung injury that allows fluid to leak into the lungs and makes it difficult for patients to breathe. More than 40 percent of individuals hospitalized for severe and critical COVID-19 develop ARDS, and 22 percent to 62 percent of those who are diagnosed and become critically ill, die from the disease. There is no effective treatment for ARDS today; MSCs potentially offer a unique therapeutic option to help patients in need.

"The analysis shows a positive trend in outcomes when treating ARDS patients with MSC therapy and represents the potential to save thousands of patients with COVID-19 induced ARDS," said Wenchun Qu, MD, PhD of the Mayo Clinic and first author of the paper. "The potential benefitcombined with the demonstrated safety of these therapiessupports the need for rapid commencement of more clinical trials."

"Acute respiratory distress syndrome is a rapidly progressive disease that can occur in critically ill patients," said Anthony Atala, MD, Editor-in-Chief of STEM CELLS Translational Medicine and director of the Wake Forest Institute for Regenerative Medicine. "Having additional potential therapies, such as MSCs, could be highly beneficial to patients with COVID-19."

To date, the FDA has approved more than a dozen investigational new drug applications for the use of MSCs for COVID-19-related conditions. The National Institutes of Health (NIH) has also supported the use of MSCs and other regenerative cell therapies to help patients with other conditions. The bipartisan 21st Century Cures Act provided $30 million in funding to the NIH over three years for clinical research for such therapies. However, these limited investments expire in fiscal year 2020.

The Alliance for Cell Therapy Now and the Regenerative Medicine Foundation support the recommendation of the authors, who urge funding for larger studies that build on the results to date. Collaboration and funding are also needed to collect and analyze the evidence from multiple ongoing and new studies, to better evaluate outcomes and potential benefits of MSC therapy for COVID-19 patients in need. A portion of the more than $10 billion in funding directed by Congress to the Biomedical Advanced Research and Development Authority (BARDA) and the NIH for COVID-19 should be used to support these goals.

About the Alliance for Cell Therapy Now

Alliance for Cell Therapy Now (ACT Now) is an independent, non-profit organization devoted to advancing the availability of and access to safe and effective cell therapies for patients in need. ACT Now convenes experts and stakeholders to develop and advance sound policies that will improve the development, manufacturing, delivery, and improvement of regenerative cell therapies. See http://allianceforcelltherapynow.org/

About the Regenerative Medicine Foundation

The non-profit Regenerative Medicine Foundation (RMF) fosters strategic collaborations to accelerate the development of regenerative medicine to improve health and deliver cures. RMF pursues its mission by producing its flagship World Stem Cell Summit, honoring leaders through the Stem Cell and Regenerative Medicine Action Awards, and promoting educational initiatives. STEM CELLS Translational Medicine is RMF's official journal partner. See https://www.regmedfoundation.org/

SOURCE Alliance for Cell Therapy Now

http://allianceforcelltherapynow.org

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MSC Therapy for Acute Respiratory Distress Syndrome; It's Time to Accelerate Clinical Trials for COVID-19 Patients in Need - PRNewswire

Groundbreaking Gene Therapies for Hereditary Diseases / Alessandro Aiuti, a physician and research scientist from Milan, receives the Else Krner…

The current coronavirus pandemic clearly illustrates how dangerous viral infections can become for us. Independent of the present situation, there are people whose bodies are defenseless against infections because their immune systems are unable to combat them - they suffer from immunodeficiency diseases such as ADA-SCID (adenosine deaminase severe combined immunodeficiency) or Wiskott-Aldrich syndrome. Prof. Dr. Alessandro Aiuti, a physician and research scientist based in Milan who works at the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) and at the Vita Salute San Raffaele University, is now being honored with the Else Krner Fresenius Prize for Medical Research 2020 for his groundbreaking successes in the development of gene therapies. The award is coupled to 2.5 million euros in prize money.

In the case of the rare immune disorder ADA-SCID, which exclusively afflicts young children and occurs about 15 times a year in Europe, a defective ADA gene within the genome disrupts lymphocyte development, leaving the young patient's body defenseless against infections. "Without effective therapy, the children rarely survive for more than 2 years because any infection can become perilous for them," Aiuti explains. Standard for this therapy is a bone marrow transplantation from a fully matched sibling. However, a suitable donor is available only for a minority of patients. "Meanwhile children with such a condition benefit from the advances we have made in the field of gene therapy. So far we have treated 36 children from 19 countries using the therapy we developed. In more than 80 percent of the cases, the treatment has had such an impact that no enzyme replacement therapy or transplantation is needed. This achievement has been made possible by the extraordinary effort and dedication of SR-Tiget researchers and clinical team throughout 25 years," Aiuti adds. All of the patients are still alive.

For these successes and his other work in the field of gene therapy, Alessandro Aiuti has now been honored with the Else Krner Fresenius Prize for Medical Research 2020 awarded by the Else Krner-Fresenius-Stiftung (EKFS) foundation. At 2.5 million euros, this award is one of the highest endowed prizes for medical research in the world. "Still young by comparison, this year the prize is being awarded for the third time. It honors research scientists for pioneering contributions in the areas of biomedical science. A major percentage of the prize money flows into the prizewinner's research and is supposed to contribute toward achieving further groundbreaking findings and medical breakthroughs in the future as well," emphasizes Prof. Dr. Michael Madeja, scientific director and member of the management board at EKFS.

The decision regarding the prize recipient was made by a ten-member international jury composed of renowned research scientists in the fields of genome editing and gene therapy along with delegates from the Scientific Commission at EKFS. Prof. Dr. Hildegard Bning, chairwoman of the jury and president of the European Society for Gene and Cell Therapy (ESGCT), substantiates the jury's decision: "Alessandro Aiuti is a truly outstanding physician and scientist. His work has decisively contributed to the development and successful treatment of rare, genetically caused disorders such as SCID. Thanks not least of all to the contributions he has made, even patients with other inheritable illnesses can presumably be treated successfully in the future."

After successful clinical trials, the gene therapy developed for ADA-SCID patients was approved as a pharmaceutical remedy in Europe. It is considered to be one of the key findings in the development of gene therapies worldwide. With this treatment certain blood stem cells (CD34+) are taken from the patient, then the cell DNA is modified. The cells are treated outside the body using a viral vector to accomplish this. The correct version of the gene for the ADA enzyme is introduced into the genome of the cells that were collected. The genetically modified cells are returned to the patient's bloodstream via intravenous infusion. A portion of the modified cells subsequently establish themselves in bone marrow again. The patient now has blood stem cells that function properly and produce lymphocytes to defend against infections - presumably on a life-long basis.

Alessandro Aiuti wants to utilize the prize money from EKFS to set the success story forth, to optimize the therapies further and map out the healing mechanisms involved in a better fashion. The scientist sees another major challenge in conveying the acquired knowledge beyond the successful gene therapies from Milan to as many other genetic disorders as possible. Alongside the therapy for ADA-SCID, the San Raffaele Telethon Institute for Gene Therapy has also developed gene therapies for four more hereditary diseases, among them the Wiskott-Aldrich syndrome and metachromatic leukodystrophy (MLD). To this day a total of more than 100 patients from 35 different countries have been treated.

Biography of Alessandro Aiuti

Alessandro Aiuti was born in Rome in 1966 and studied medicine there at Sapienza University. Following a stay at Harvard Medical School in Boston, Massachusetts in the USA, he received his doctorate in Human Biology in 1996 from Sapienza University. Since 1997 he has been active at the San Raffaele Scientific Institute in Milan, where he meanwhile also teaches as a professor at the Vita Salute San Raffaele University. He is furthermore Deputy Director of Clinical Research at the San Raffaele Telethon Institute for Gene Therapy and Head of the Pediatric Immunohematology Unit at San Raffaele Hospital.

Aiuti is the author of numerous and highly acclaimed publications. Over the course of his career he has received a number of prizes from national and international institutions. Aiuti is a member of the board of the European Society of Gene and Cell Therapy, and a member of the EMA Committee for Advanced Therapies since 2019.

The Else Krner Fresenius Prize for Medical Research

The international Else Krner Fresenius Prize for Medical Research came into existence in 2013 on the occasion of the 25th anniversary of Else Krner's death and is awarded in alternating fields of biomedical science. Endowed with 2.5 million euros, the prize is one of the most highly endowed medical research awards in the world. It honors and supports research scientists who have made significant scientific contributions in their fields and whose work can be expected to yield groundbreaking findings and medical breakthroughs in the future as well.

The Else Krner-Fresenius-Stiftung (EKFS) foundation - Advancing research. Helping people.

The Else Krner-Fresenius-Stiftung, a non-profit foundation, is dedicated to the funding of medical research and supports medical/humanitarian projects. The foundation was established in 1983 by entrepreneur Else Krner and appointed as her sole heir. EKFS receives virtually all of its income in dividends from the Fresenius healthcare group, in which the foundation is the majority shareholder. To date, the foundation has funded around 2,000 projects. With a current annual funding volume around 60 million euros the EKFS is one of the largest foundations for medicine in Germany. More information:www.ekfs.de.

The San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget)

Based in Milan, Italy, the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) is a joint venture between the Ospedale San Raffaele and Fondazione Telethon. SR-Tiget was established in 1995 to perform research on gene transfer and cell transplantation and translate its results into clinical applications of gene and cell therapies for different genetic diseases. Over the years, the Institute has given a pioneering contribution to the field with relevant discoveries in vector design, gene transfer strategies, stem cell biology, identity and mechanism of action of innate immune cells. SR-Tiget has also established the resources and framework for translating these advances into novel experimental therapies and has implemented several successful gene therapy clinical trials for inherited immunodeficiencies, blood and storage disorders, which have already treated >115 patients and have led through collaboration with industrial partners to the filing and approval of novel advanced gene therapy medicines.

Fondazione Telethon

Fondazione Telethon is a non-profit organisation created in 1990 as a response to the appeals of a patient association group of stakeholders, who saw scientific research as the only real opportunity to effectively fight genetic diseases. Thanks to the funds raised through the television marathon, along with other initiatives and a network of partners and volunteers, Telethon finances the best scientific research on rare genetic diseases, evaluated and selected by independent internationally renowned experts, with the ultimate objective of making the treatments developed available to everyone who needs them. Throughout its 30 years of activity, Fondazione Telethon has invested more than EUR 528 million in funding more than 2.630 projects to study more than 570 diseases, involving over 1.600 scientists. Fondazione Telethon has made a significant contribution to the worldwide advancement of knowledge regarding rare genetic diseases and of academic research and drug development with a view to developing treatments. For more information, please visit:www.telethon.it

Issued by news aktuell/ots on behalf of Else Krner-Fresenius-Stiftung

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Groundbreaking Gene Therapies for Hereditary Diseases / Alessandro Aiuti, a physician and research scientist from Milan, receives the Else Krner...

Huge Growth Expected in Global Single-Cell Analysis Market in Future – Cole of Duty

The single-cell analysis market generated revenue of $1,688.9 million in 2015, and it is projected to grow at an 18.1% CAGR during the forecast period. The market is expected to be driven by the growing geriatric population, rising chronic disease prevalence, and increasing focus on personalized medicine. The study of individual cells isolated from multi-cellular organisms is referred to as single-cell analysis, which aims to study the heterogenous cell population. These studies are conducted in stem cell, neurological, cancer, and immunological research to help diagnose and treat various diseases.

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The single-cell analysis market is experiencing growth due to the rising healthcare expenditure across the globe. With the increasing prevalence of various diseases, governments of many countries are focusing more on improving the healthcare infrastructure. This fact has been agreed on by the World Health Organization, which reported that the total healthcare expenditure has witnessed an increase worldwide, thereby resulting in improvements in healthcare facilities. This is enabling people from different strata of the society in accessing healthcare facilities and tests involving single-cell analysis.

The geography segment of the single-cell analysis market is classified into Europe, Latin America, Asia, North America, and Rest of the World, among which the largest share in 2015 was accumulated by the North American region. Technical advancements in single-cell analysis products and growing geriatric population were instrumental in the North American markets growth. However, the fastest growth during the forecast period is expected to be witnessed by the Asian market, due to its large pool of patients and increasing awareness about new diagnostic techniques, such as single-cell analysis.

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GLOBAL SINGLE-CELL ANALYSIS MARKET

GLOBAL SINGLE-CELL ANALYSIS MARKET, BY TYPE OF PRODUCT

GLOBAL SINGLE-CELL ANALYSIS MARKET, BY TYPE OF CELL

GLOBAL SINGLE-CELL ANALYSIS MARKET, BY TYPE OF TECHNIQUE

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Huge Growth Expected in Global Single-Cell Analysis Market in Future - Cole of Duty