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Category Archives: Stem Cell Therapy
Stem Cell Therapy Market Information, Figures and Analytical Insights 2020 2026 – The Courier
Posted: February 7, 2021 at 12:54 am
The report contains an overview explaining Stem Cell Therapy Market on a world and regional basis. Global Stem Cell Therapy market report is a definitive source of information and provides the latest market research, evolving consumer trends with actionable information about new players, products, and technologies. Our analysts have statistical data to provide information about the statistical report, including the factors that drive and impede the market growth.
The study is an integrated effort of primary and secondary research. The report provides an overview of the key drivers affecting the generation and growth limitation of Stem Cell Therapy market. In addition, the report also examines competitive developments, such as mergers and acquisitions, new partnerships, new contracts, and new products in the world market. The past trends and future prospects presented in this report make it very comprehensible to market analysis. Furthermore, the latest trends, product portfolio, demography, geographic segmentation, and market regulatory framework Stem Cell Therapy were also included in the study.
Description:
Market Segment according to type covers:
Market segment by applications may be broken down into:
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Fundamental Highlights
And More
The following section also highlights the supply-to-consumption gap. In addition to the above data, the growth rate of Stem Cell Therapy market in 2026 is also explained. Moreover, consumption charts by type and application are also given.
Purpose of Studies:
World Market Report Stem Cell Therapy Industry primarily covers 10 sections in the table as follows:
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Stem Cell Therapy Market Information, Figures and Analytical Insights 2020 2026 - The Courier
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Groundbreaking Trial Shows Umbilical-Cord Derived Mesenchymal Stem Cell Infusions Save Lives of Sickest COVID-19 Patients – HospiMedica
Posted: January 20, 2021 at 6:49 pm
Image: Camillo Ricordi, M.D., director of the Diabetes Research Institute (DRI) and Cell Transplant Center at the University of Miami Miller School of Medicine (Photo courtesy of University of Miami Health System)
Researchers at the University of Miami Miller School of Medicine (Miami, FL, USA) who led the study believe that treating COVID-19 with mesenchymal stem cells makes sense. Mesenchymal cells not only help correct immune and inflammatory responses that go awry, they also have antimicrobial activity and have been shown to promote tissue regeneration. When given intravenously, mesenchymal stem cells migrate naturally to the lungs. Thats where therapy is needed in COVID-19 patients with acute respiratory distress syndrome, a dangerous complication associated with severe inflammation and fluid buildup in the lungs.
In the new study, 24 hospitalized COVID-19 patients who had developed severe acute respiratory distress syndrome each received two infusions given days apart of either mesenchymal stem cells or a placebo. Researchers found the treatment was safe, with no infusion-related serious adverse events. Patient survival at one month was 91% in the stem cell treated group versus 42% in the control group. Among patients younger than 85 years old, 100% of those treated with mesenchymal stem cells survived at one month.
The researchers also found that recovery was faster among those in the treatment arm. More than half of patients treated with mesenchymal stem cell infusions recovered and went home from the hospital within two weeks after the last treatment. More than 80% of the treatment group recovered by day 30, versus less than 37% in the control group. The next step is to study use of the stem cells in COVID-19 patients who have not yet become severely ill but are at risk of having to be intubated, to determine if the infusions prevent disease progression.
The umbilical cord contains progenitor stem cells, or mesenchymal stem cells, that can be expanded and provide therapeutic doses for over 10,000 patients from a single umbilical cord, said the studys senior author, Camillo Ricordi, M.D., director of the Diabetes Research Institute (DRI) and Cell Transplant Center at the University of Miami Miller School of Medicine. Its a unique resource of cells that are under investigation for their possible use in cell therapy applications, anytime you have to modulate immune response or inflammatory response.
Our results confirm the powerful anti-inflammatory, immunomodulatory effect of UC-MSC (umbilical-cord derived mesenchymal stem cells). These cells have clearly inhibited the cytokine storm, a hallmark of severe COVID-19, said Giacomo Lanzoni, Ph.D., lead author of the paper and assistant research professor at the Diabetes Research Institute. The results are critically important not only for COVID-19 but also for other diseases characterized by aberrant and hyperinflammatory immune responses, such as autoimmune type 1 diabetes.
Related Links:University of Miami Miller School of Medicine
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Bone Therapeutics, Rigenerand Ink Cell Therapy Deal – Contract Pharma
Posted: January 20, 2021 at 6:49 pm
Bone Therapeutics, a cell therapy company addressing unmet medical needs in orthopedics and other diseases, and Rigenerand SRL, a biotech company that both develops and manufactures medicinal products for cell therapy applications, primarily for regenerative medicine and oncology, have signed an agreement for a process development partnership.Allogeneic mesenchymal stem cell (MSC) therapies are currently being developed at a fast pace and are evaluated in numerous clinical studies covering diverse therapeutic areas such as bone and cartilage conditions, liver, cardiovascular and autoimmune diseases in which MSCs could have a significant positive effect.Advances in process development to scale up these therapies could have major impacts for both their approval and commercial viability. This will be essential to bring these therapies to market to benefit patients as quickly as possible, said Miguel Forte, chief executive officer, Bone Therapeutics. While Bone Therapeutics is driving on its existing clinical development programs, we have signed a first formal agreement with Rigenerand as a fellow MSC-based organization. This will result in both companies sharing extensive expertise in the process development and manufacturing of MSCs and cell and gene therapy medicinal products. Bone Therapeutics also selected Rigenerand to partner with for their additional experience with wider process development of advanced therapy medicinal products (ATMPs), including the conditioning and editing of MSCs.The scope of collaborations between Bone Therapeutics and Rigenerand aims to focus on different aspects of product and process development for Bone Therapeutics expanding therapeutic portfolio. Rigenerand will contribute to improving the processes involved in the development and manufacture of Bone Therapeutics MSC based allogeneic differentiated cell therapy products as they advance towards patients. The first collaboration between the two organizations will initially focus on augmented professional bone-forming cellscells that are differentiated and programmed for a specific task. There is also potential for Bone Therapeutics to broaden its therapeutic targets and explore new mechanisms of action with potential gene modifications for its therapeutic portfolio.In addition to Rigenerands MSC expertise, Bone Therapeutics also selected Rigenerand as a partner for Rigenerands GMP manufacturing facility. This facility, situated in Modena, Italy, has been designed to host a number of types of development processes for ATMPs. These include somatic, tissue engineered and gene therapy processes. These multiple areas of Rigenerand capabilities enable critical development of new processes and implementation of the gene modification of existing processes. In addition, Rigenerand has built considerable experience in cGMP manufacturing of MSC-based medicinal products, including those that are genetically modified.Process development and manufacturing is a key part of the development for ATMPs internationally. Navigating these therapies through the clinical development phase and into the market requires a carefully considered process development pathway, said Massimo Dominici, scientific founder, Rigenerand, professor of medical oncology, and former president of the International Society for Cell & Gene Therapy (ISCT). This pathway needs to be flexible, as both the market and materials of these therapies continues to evolve alongside an improved clinical efficacy.Giorgio Mari, chief executive officer, Rigenerand, said, Rigenerand will offer considerable input from its experience of MSC-based therapies to enable Bone Therapeutics to keep and further accelerate the pace in development of the product processes of its MSC based allogeneic differentiated cell therapy as they advance towards patients. We will continue to use our MSC expertise in the development of Rigenerands own products, as well as in process development and manufacturing cell and gene therapies for partner organizations across the globe.
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Bone Therapeutics, Rigenerand Ink Cell Therapy Deal - Contract Pharma
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Stem Cell Therapy Market: Clear Understanding of The Competitive Landscape and Key Product Segments 2026 – NeighborWebSJ
Posted: January 20, 2021 at 6:49 pm
Global Stem Cell Therapy Research Report offers the most segmented view of sales data, consumption fields, market size, and revenue across different regions and countries. The vital Stem Cell Therapy insights are derived from primary and secondary authoritative sources. The market dynamics, mergers and acquisitions, Stem Cell Therapy investment feasibility is analyzed in detail. The competitive landscape analyzes the top leading players, market share, revenue, Stem Cell Therapy product portfolio, and opportunities. The qualitative and quantitative methods are used to estimate the Stem Cell Therapy forecast scenario in micro and macro markets. The strategic analysis of Stem Cell Therapy marketing channels, positioning, growth strategies, new entrants, and existing player's competition is done. The product or service which shows more customer inclinations, technological advancements, and economic developments are analyzed.
Request A Free Sample Report to understand the market and have an [emailprotected]https://www.reportscheck.com/shop/2021-2026-report-on-global-stem-cell-therapy-market-by-player-region-type-application-and-sales-channel-2/#sample-request
Osiris TherapeuticsNuVasiveChiesi PharmaceuticalsJCRPharmaceuticalPharmicellMedi-postAnterogenMolmedTakeda (TiGenix)
The product-wise categorization is as follows:
AutologousAllogeneic
The application-level analysis is as follows:
Musculoskeletal DisorderWounds & InjuriesCorneaCardiovascular DiseasesOthers
Check complete table of contents and report details [emailprotected]https://www.reportscheck.com/shop/2021-2026-report-on-global-stem-cell-therapy-market-by-player-region-type-application-and-sales-channel-2/#table-of-contents
The top regions analyzed in this report are North America, Europe, Asia-Pacific, Latin America, Middle East & Africa, and the rest. Also, these regions are further broken down based on Stem Cell Therapy presence in United States, Germany, France, UK, Spain, Italy, Poland, Russia, China, India, Japan, South Korea, Thailand, Indonesia, Philippines, Malaysia, Vietnam, Singapore, Brazil, Argentina, Saudi Arabia, UAE, Qatar, Bahrain and rest. The historical analysis is conducted from 2015-2019, with the base year as 2019, estimated year as 2020, and the forecast period is from 2020-2027.
Stem Cell Therapy analysis report covers the future growth scenario by 2026, with market shares and growth opportunities. The growing demand for Stem Cell Therapy in developed and developing countries, product features, and a wide range of applications will foster industry growth.
Explore complete details and insights with structured free sample [emailprotected]https://www.reportscheck.com/shop/2021-2026-report-on-global-stem-cell-therapy-market-by-player-region-type-application-and-sales-channel-2/
The report begins with Stem Cell Therapy Industry overview, introduction, objectives, and market definition. The market segmentation by type, geographies, applications, and top companies is provided. An increase in Stem Cell Therapy demand, trends, development, and SWOT analysis is provided. The five-year forecast assessment will help in analyzing the industry drivers, restraints, key product segments that will lead to informed decision making.
The vendors, suppliers, traders, distributors, raw material suppliers are analyzed in detail by the Reportscheck team. Even the Stem Cell Therapy analysis based on population, route of administration, distribution channel, and demand is done. The recent developments, the impact of domestic and localized Stem Cell Therapy market players, market regulations, product approvals, and launches is stated.
1. What is the investment feasibility for the new Stem Cell Therapy market entrants and what are the growth opportunities?
2. Which is the most profitable segment in terms of revenue accumulation, market size, geographical presence, and market share?
3. Which key trends, regulatory scenarios, and developments are key attractions for the emerging and existing market players?
4. What are the marketing strategies followed by top company players which keep them ahead of the competition?
5. How COVID-19 pandemic is impact different Stem Cell Therapy economies across different geographies?
6. Which are the growth driving Stem Cell Therapy industry elements which will lead to revenue maximization, new product launches, and lucrative profits?
The complete historical, real-time, as well as forecast developments impacting the market, are studied. The comprehensive company profiles will offer a clear picture of dominating market players. The revenue share analysis by key players will lead to an understanding of the growing scope in this field. Also, valuable conclusions, analyst opinions, implied research methodology is provided.
To understand the market scenario or for any queries contact our analyst team to create a revenue impact solution for your business.
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Marketing Manager
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Stem Cell Therapy Market: Clear Understanding of The Competitive Landscape and Key Product Segments 2026 - NeighborWebSJ
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Impact of COVID-19 on Canine Stem Cell Therapy Market 2021 | Size, Growth, Demand, Opportunities & Forecast To 2027 | VETSTEM BIOPHARMA, Cell…
Posted: January 20, 2021 at 6:49 pm
Canine Stem Cell Therapy Market research report is the new statistical data source added by A2Z Market Research.
Canine Stem Cell Therapy Market is growing at a High CAGR during the forecast period 2021-2027. The increasing interest of the individuals in this industry is that the major reason for the expansion of this market.
Canine Stem Cell Therapy Market research is an intelligence report with meticulous efforts undertaken to study the right and valuable information. The data which has been looked upon is done considering both, the existing top players and the upcoming competitors. Business strategies of the key players and the new entering market industries are studied in detail. Well explained SWOT analysis, revenue share and contact information are shared in this report analysis.
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Note In order to provide more accurate market forecast, all our reports will be updated before delivery by considering the impact of COVID-19.
Top Key Players Profiled in this report are:
VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus, Aratana Therapeutics, Medivet Biologics, Okyanos, .
The key questions answered in this report:
Various factors are responsible for the markets growth trajectory, which are studied at length in the report. In addition, the report lists down the restraints that are posing threat to the global Canine Stem Cell Therapy market. It also gauges the bargaining power of suppliers and buyers, threat from new entrants and product substitute, and the degree of competition prevailing in the market. The influence of the latest government guidelines is also analyzed in detail in the report. It studies the Canine Stem Cell Therapy markets trajectory between forecast periods.
Global Canine Stem Cell Therapy Market Segmentation:
Market Segmentation: By Type
* Allogeneic Stem Cells* Autologous Stem cells
Market Segmentation: By Application
* Veterinary Hospitals* Veterinary Clinics* Veterinary Research Institutes
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Regions Covered in the Global Canine Stem Cell Therapy Market Report 2021: The Middle East and Africa (GCC Countries and Egypt) North America (the United States, Mexico, and Canada) South America (Brazil etc.) Europe (Turkey, Germany, Russia UK, Italy, France, etc.) Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)
The cost analysis of the Global Canine Stem Cell Therapy Market has been performed while keeping in view manufacturing expenses, labor cost, and raw materials and their market concentration rate, suppliers, and price trend. Other factors such as Supply chain, downstream buyers, and sourcing strategy have been assessed to provide a complete and in-depth view of the market. Buyers of the report will also be exposed to a study on market positioning with factors such as target client, brand strategy, and price strategy taken into consideration.
The report provides insights on the following pointers:
Market Penetration: Comprehensive information on the product portfolios of the top players in the Canine Stem Cell Therapy market.
Product Development/Innovation: Detailed insights on the upcoming technologies, R&D activities, and product launches in the market.
Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments of the leading players in the market.
Market Development: Comprehensive information about emerging markets. This report analyzes the market for various segments across geographies.
Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the Canine Stem Cell Therapy market.
Table of Contents
Global Canine Stem Cell Therapy Market Research Report 2021 2027
Chapter 1 Canine Stem Cell Therapy Market Overview
Chapter 2 Global Economic Impact on Industry
Chapter 3 Global Market Competition by Manufacturers
Chapter 4 Global Production, Revenue (Value) by Region
Chapter 5 Global Supply (Production), Consumption, Export, Import by Regions
Chapter 6 Global Production, Revenue (Value), Price Trend by Type
Chapter 7 Global Market Analysis by Application
Chapter 8 Manufacturing Cost Analysis
Chapter 9 Industrial Chain, Sourcing Strategy and Downstream Buyers
Chapter 10 Marketing Strategy Analysis, Distributors/Traders
Chapter 11 Market Effect Factors Analysis
Chapter 12 Global Canine Stem Cell Therapy Market Forecast
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BrainStorm Announces the Publication of Preclinical Data Highlighting the Potential of a NurOwn Derived Exosome-Based Treatment for COVID-19 ARDS -…
Posted: January 20, 2021 at 6:49 pm
NEW YORK, Jan. 20, 2021 /PRNewswire/ --BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today the peer-reviewed publication of a preclinical study in the journal Stem Cell and Research Therapy. The study, entitled "MSC-NTF (NurOwn) exosomes: a novel therapeutic modality in the mouse LPS-induced ARDS model," evaluated the use of NurOwn (MSC-NTF cell) derived exosomes in a mouse model of acute respiratory distress syndrome (ARDS).
ARDS is a type of respiratory failure that is frequently associated with COVID-19 and mediated by dysregulated cytokine production. While there are currently no effective therapies to prevent or reverse ARDS, mesenchymal stem cell (MSC)-derived exosomes have been suggested as a potential novel treatment option due to their ability to penetrate deep into tissues and efficiently deliver immunomodulatory molecules.
Results from the recently published study showed that intratracheal administration of NurOwn derived exosomes led to a statistically significant reduction in lung disease severity score (p < 0.05; based on criteria set forth by the American Thoracic Society Documents: Matute-Bello et al., Am J Respir Cell Mol Biol 44;725-738, 2011) and improvements in several additional clinically relevant lipopolysaccharide (LPS)-induced ARDS markers such as lung function, fibrin presence, neutrophil accumulation, cytokine expression, and blood oxygenation levels. Notably, these improvements were significantly superior to those observed following administration of nave MSC-derived exosomes.
"These exciting preclinical data suggest that NurOwn derived exosomes have the potential to treat COVID-19-induced ARDS or other severe respiratory complications, and that they are more effective than exosomes isolated from nave MSCs at combatting the various symptoms of the syndrome," said Dr. Revital Aricha, Vice President of Research & Development at BrainStorm. "This publication in a highly regarded journal provides important validation for the scientific advances and significance of BrainStorm's preclinical research programs, including on our exosome-based technology platform."
Chaim Lebovits, Brainstorm's Chief Executive Officer added, "While our primary focus is on advancing NurOwn towards regulatory approval in ALS, we continue to evaluate the potential of our exosome-based platform to address unmet medical needs. The publication of these proof-of-concept data highlights this potential, and we are now actively assessing next steps to determine how to best generate value. We are also actively discussing with possible partners several development opportunities for the exosome technology."
About NurOwn
The NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.
About BrainStorm Cell Therapeutics Inc.
BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm is in active discussions with the FDA to identify regulatory pathways that may support NurOwn's approval in ALS. BrainStorm is also conducting an FDA-approved phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed dosing inDecember 2020, and topline results are expected by the end of the first quarter 2021.
For more information, visit the company's website atwww.brainstorm-cell.com.
Safe-Harbor Statement
Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect,""likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
Logo - https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg
CONTACTS
Investor Relations:Corey Davis, Ph.D.LifeSci Advisors, LLCPhone: +1-646-465-1138[emailprotected]
Media:Paul TyahlaSmithSolvePhone: +1-973-713-3768[emailprotected]
SOURCE Brainstorm Cell Therapeutics Inc
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Bone Therapeutics and Rigenerand sign partnership for cell therapy process development – GlobeNewswire
Posted: January 20, 2021 at 6:49 pm
Gosselies, Belgium and Modena, Italy, 14January 2021, 7am CET BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, and Rigenerand SRL, the biotech company that both develops and manufactures medicinal products for cell therapy applications, primarily for regenerative medicine and oncology, today announce the signing of a first agreement for a process development partnership.
Allogeneic mesenchymal stem cell (MSC) therapies are currently being developed at an incredible pace and are evaluated in numerous clinical studies covering diverse therapeutic areas such as bone and cartilage conditions, liver, cardiovascular and autoimmune diseases in which MSCs could have a significant positive effect. Advances in process development to scale up these therapies could have major impacts for both their approval and commercial viability. This will be essential to bring these therapies to market to benefit patients as quickly as possible, said Miguel Forte, CEO, Bone Therapeutics. Hence, whilst Bone Therapeutics is driving on its existing clinical development programs, we have signed a first formal agreement with Rigenerand as a fellow MSC-based organization. This will result in both companies sharing extensive expertise in the process development and manufacturing of MSCs and cell and gene therapy medicinal products. Bone Therapeutics also selected Rigenerand to partner with for their additional experience with wider process development of advanced therapy medicinal products (ATMPs), including the conditioning and editing of MSCs. Rigenerand was founded by Massimo Dominici, a world opinion leader in the cell therapy with an unparalleled MSC expertise and knowledge.
The scope of collaborations between Bone Therapeutics and Rigenerand aims to focus on different aspects of product and process development for Bone Therapeutics expanding therapeutic portfolio. Rigenerand will contribute to improving the processes involved in the development and manufacture of Bone Therapeutics MSC based allogeneic differentiated cell therapy products as they advance towards patients. The first collaboration between the two organizations will initially focus on augmented professional bone-forming cells cells that are differentiated and programmed for a specific task. There is also potential for Bone Therapeutics to broaden its therapeutic targets and explore new mechanisms of action with potential gene modifications for its therapeutic portfolio.
In addition to Rigenerands MSC expertise, Bone Therapeutics also selected Rigenerand as a partner for Rigenerands GMP manufacturing facility. This facility, situated in Modena, Italy, has been designed to host a number of types of development processes for ATMPs. These include somatic, tissue engineered and gene therapy processes. These multiple areas of Rigenerand capabilities enable critical development of new processes and implementation of the gene modification of existing processes. In addition, Rigenerand has built considerable experience in cGMP manufacturing of MSC-based medicinal products, including those that are genetically modified.
Process development and manufacturing is a key part of the development for ATMPs internationally. Navigating these therapies through the clinical development phase and into the market requires a carefully considered process development pathway, said Massimo Dominici, scientific founder, Rigenerand, professor of medical oncology, and former President of the International Society for Cell & Gene Therapy (ISCT). This pathway needs to be flexible, as both the market and materials of these therapies continues to evolve alongside an improved clinical efficacy.
Rigenerand will offer considerable input from its experience of MSC-based therapies to enable Bone Therapeutics to keep and further accelerate the pace in development of the product processes of its MSC based allogeneic differentiated cell therapy as they advance towards patients, said Giorgio Mari, CEO, Rigenerand. We will continue to use our MSC expertise in the development of Rigenerands own products, as well as in process development and manufacturing cell and gene therapies for partner organizations across the globe.
About Bone Therapeutics
Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a, diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.
Bone Therapeutics is developing an off-the-shelf next-generation improved viscosupplement, JTA-004, which is currently in Phase III development for the treatment of pain in knee osteoarthritis. Consisting of a unique combination of plasma proteins, hyaluronic acid - a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. Positive Phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement.
Bone Therapeutics core technology is based on its cutting-edge allogeneic cell therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company has initiated patient recruitment for the Phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.
Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.
About Rigenerand
Rigenerand SRL is a biotech company that both develops and manufactures medicinal products for cell therapy applications, primarily for regenerative medicine and oncology and 3D bioreactors as alternative to animal testing for pre-clinical investigations.
Rigenerand operates through three divisions:
Rigenerand is developing RR001, a proprietary ATMP gene therapy medicinal product for the treatment of pancreatic ductal adenocarcinoma (PDAC). RR001 has been granted an Orphan Drug Designation (ODD) by US-FDA and from the European Medicine Agency. The Clinical trial is expected to start in Q2 2021.
Rigenerand is headquartered in Medolla, Modena, Italy, with more than 1,200 square metres of offices, R&D and quality control laboratories and a cell factory of 450 square metres of sterile cleanroom (EuGMP Grade-B) with BSL2/BSL3 suites for cell and gene therapies manufacturing. It combines leaders and academics from biopharma and medical device manufacturing sectors.
For further information, please contact:
Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0)71 12 10 00investorrelations@bonetherapeutics.com
For Belgian Media and Investor Enquiries:BepublicCatherine HaquenneTel: +32 (0)497 75 63 56catherine@bepublic.be
International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20 8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency
For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: +33 (0)1 44 71 94 94bone@newcap.eu
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
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Bone Therapeutics and Rigenerand sign partnership for cell therapy process development - GlobeNewswire
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Autologous stem cell transplantation versus bortezomib for the first line treatment of systemic light chain amyloidosis in the UK – DocWire News
Posted: January 20, 2021 at 6:49 pm
This article was originally published here
Eur J Haematol. 2021 Jan 18. doi: 10.1111/ejh.13582. Online ahead of print.
ABSTRACT
OBJECTIVES: The benefit of autologous stem cell transplantation (ASCT) in the treatment of light chain (AL) amyloidosis requires re-evaluation in the modern era. This retrospective case-matched study compares ASCT to bortezomib for the treatment of patients with AL amyloidosis.
METHODS: Newly diagnosed patients with AL amyloidosis treated with ASCT or bortezomib between 2001-2018 were identified. Patients were excluded if the time from diagnosis to treatment exceeded 12 months. Patients were matched on a 1:1 basis, using a propensity matched scoring approach.
RESULTS: A total of 136 propensity-score matched patients were included (ASCT n= 68, bortezomib n=68). There was no significant difference in overall survival at two years (p=0.908, HR: 0.95, CI:0.41-2.20). For ASCT vs. bortezomib: overall haematological response rate at six months was 90.6% vs. 92.5%; organ response at 12 months: cardiac (70.0% vs. 54%, p>0.999), renal (74% vs.24%, p=0.463)) liver (21% vs. 22%, p=0.048); median progression free survival (50 vs. 42 months p=0.058, HR:0.61, CI:0.37-1.02) and time to next treatment (68 vs. 45 months, p=0.145, HR:0.61, CI:0.31-1.19). More patients required treatment in the bortezomib group compared to ASCT group at 24 months (41 vs. 23, Chi squared p=0.004) and 48 months (57 vs 41, Chi squared p= 0.004).
CONCLUSIONS: This small retrospective study suggests that there is no clear survival advantage of ASCT over bortezomib therapy. A prospective randomised controlled trial evaluating ASCT in AL amyloidosis is critically needed.
PMID:33460466 | DOI:10.1111/ejh.13582
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Autologous stem cell transplantation versus bortezomib for the first line treatment of systemic light chain amyloidosis in the UK - DocWire News
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Adipose Derived Stem Cell Therapy Market 2018: Production, Sales, Supply, Demand, Analysis and Forecast To 2026 | BioRestorative Therapies, Inc.,…
Posted: January 20, 2021 at 6:49 pm
The Global Adipose Derived Stem Cell Therapy Market report provides a holistic evaluation of the market for the forecast period (20192025). The report comprises various segments as well as an analysis of the trends and factors that are playing a substantial role in the market. These factors; the market dynamics involve the drivers, restraints, opportunities and challenges through which the impact of these factors in the market are outlined. The drivers and restraints are intrinsic factors whereas opportunities and challenges are extrinsic factors of the market. The Global Adipose Derived Stem Cell Therapy Market study provides an outlook on the development of the market in terms of revenue throughout the prognosis period.
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Adipose derived stem cells (ADSCs) are stem cells derived from adipocytes, and can differentiate into variety of cell types. ADSCs have multipotency similar to bone marrow mesenchymal stem cells, thus ADSCs substitute for bone marrow as a source of stem cells. Numerous manual and automatic stem cell separation procedures are adopted in order to separate adipose stem cells (ASCs) from adipose tissue. Flow cytometry can also be used to isolate ADSCs from other stem cells within a cell solution.
Major Players included in this report are as follows BioRestorative Therapies, Inc., Celltex Therapeutics Corporation, Antria, Inc., Cytori Therapeutics Inc., Intrexon Corporation, Mesoblast Ltd., iXCells Biotechnologies, Pluristem Therapeutics, Inc., Thermo Fisher Scientific, Inc., Tissue Genesis, Inc., Cyagen US Inc., Celprogen, Inc., and Lonza Group, among others.
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PureTech Founded Entity Vor Announces FDA Clearance of IND Application for VOR33 – Business Wire
Posted: January 20, 2021 at 6:49 pm
BOSTON--(BUSINESS WIRE)--PureTech Health plc (LSE: PRTC, NASDAQ: PRTC) (PureTech or the Company) is pleased to note that its Founded Entity, Vor Biopharma, a clinical-stage cell therapy company pioneering engineered hematopoietic stem cell (eHSC) therapies combined with targeted therapies for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared the companys Investigational New Drug (IND) application for VOR33, an eHSC therapy candidate being developed for the treatment of acute myeloid leukemia (AML). Vor plans to initiate a Phase 1/2a clinical trial for VOR33 in the first half of this year.
VOR33, consisting of hematopoietic stem cells that are engineered to lack the CD33 protein, is a cell therapy candidate intended to replace the standard of care in hematopoietic stem cell transplant settings for patients with AML who are at high-risk for relapse.
The full text of the announcement from Vor Biopharma is as follows:
Vor Announces FDA Clearance of IND Application for VOR33
Phase 1/2a clinical trial expected to begin in first half of 2021
CAMBRIDGE, MA January 14, 2021 Vor Biopharma, a clinical-stage cell therapy company pioneering engineered hematopoietic stem cell (eHSC) therapies combined with targeted therapies for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared the companys Investigational New Drug (IND) application for VOR33, an eHSC therapy candidate being developed for the treatment of acute myeloid leukemia (AML). The company plans to initiate a Phase 1/2a clinical trial for VOR33 in the first half of this year.
VOR33, consisting of hematopoietic stem cells that are engineered to lack the CD33 protein, is a cell therapy candidate intended to replace the standard of care in hematopoietic stem cell transplant settings for patients with AML who are at high-risk for relapse.
Though advances have been made in the treatment of AML and other myeloid malignancies, the median overall five-year survival rate for patients diagnosed with AML remains under 30 percent, said Christopher Slapak, MD, Vors Chief Medical Officer. With the development of VOR33, we are seeking to change the treatment paradigm for AML and potentially other hematologic malignancies. We engineered VOR33 to provide patients with a hematopoietic stem cell transplant that we believe, upon hematopoietic reconstitution, will be treatment resistant to CD33 targeted therapies, potentially resulting in new treatment options and improved post-transplant outcomes.
Clearance of this IND is the culmination of an incredible team effort at Vor and represents a key milestone for us, added Robert Ang, MBBS, MBA, Vors President and Chief Executive Officer. This brings us an important step closer to treating patients with our potentially transformative therapy.
The Phase 1/2a trial is expected to enroll patients with CD33-positive AML who are at high risk of relapse. The primary goals of the trial are to evaluate tolerability and feasibility of the VOR33 stem cell transplant, with a focus on confirming that VOR33 can engraft normally. Following engraftment, patients will be eligible to be treated with Mylotarg, an FDA approved CD33-directed antibody drug conjugate (ADC) therapy owned by Pfizer, in order to potentially prolong leukemia-free survival and provide evidence that VOR33 protects against the myelosuppression that typically accompanies treatment with Mylotarg.
About VOR33
VOR33 is Vors lead product candidate, consisting of eHSCs that we have engineered to lack the protein CD33, and is designed to replace the standard of care in transplant settings for patients suffering from AML and potentially other hematologic malignancies. Once the VOR33 cells have engrafted, we believe that patients can be treated with anti-CD33 therapies, such as Mylotarg or, if approved by the FDA, Vors in-licensed CD33 chimeric antigen receptor T-cell (CAR-T) therapy candidate, with limited on-target toxicity, leading to durable anti-tumor activity and potential cures. In preclinical studies, we have observed that the removal of CD33 provided robust protection of VOR33 eHSCs from the cytotoxic effects of CD33-directed therapies, yet had no deleterious effects on the differentiation or function of hematopoietic cells.
About Vor Biopharma
Vor Biopharma is a clinical-stage cell therapy company that aims to transform the lives of cancer patients by pioneering eHSC therapies to create next-generation, treatment-resistant transplants that unlock the potential of targeted therapies. By removing biologically redundant proteins from eHSCs, we design these cells and their progeny to be treatment-resistant to complementary targeted therapies, thereby enabling these therapies to selectively destroy cancerous cells while sparing healthy cells.
Our platform could be used to potentially change the treatment paradigm of both hematopoietic stem cell transplants and targeted therapies, such as ADCs, bispecific antibodies and CAR-T cell treatments, including Vors in-licensed CD33 CAR-T.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, including intractable cancers, lymphatic and gastrointestinal diseases, central nervous system disorders and inflammatory and immunological diseases, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTechs Founded Entities, as of the date of PureTechs most recently filed Registration Statement on Form 20-F, was comprised of 24 products and product candidates, including two that have received FDA clearance and European marketing authorization. All of the underlying programs and platforms that resulted in this pipeline of product candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the Companys unique insights into the biology of the brain, immune and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis.
For more information, visit http://www.puretechhealth.com or connect with us on Twitter @puretechh.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are or may be forward-looking statements, including statements that relate to our product candidates and approach towards addressing major diseases, future prospects, developments, and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, expectations regarding the initiation of a Phase 1/2a clinical trial for VOR33 in the first half of this year, the potential therapeutic benefits of VOR33 and those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.
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PureTech Founded Entity Vor Announces FDA Clearance of IND Application for VOR33 - Business Wire
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