Stem Cell Clinic

Results From Pivotal Phase 2/3 Study of Emapalumab in Patients With Primary HLH Published in New England Journal of Medicine – BioSpace

By adminMay 7, 2020Stem Cell Medical Center

STOCKHOLM, May 7, 2020 /PRNewswire/ -- Sobi announced today that the results from the pivotal phase 2/3 study evaluating the efficacy and safety of emapalumab in patients with primary haemophagocytic lymphohistiocytosis (HLH) were published in the New England Journal of Medicine on 7 May 2020. Emapalumab is the first therapy approved by the US Food & Drug Administration (FDA) for primary HLH and is under review by the European Medicines Agency (EMA).

Primary HLH is a rare syndrome that typically presents in infancy but can also be seen in adults and is associated with high morbidity and mortality. This life-threatening disease is characterised by immune dysregulation and uncontrolled hyperinflammation. The treatment objective is to suppress the hyperinflammation and control the acute features of the disease in order to successfully bring patients to haematopoietic stem cell transplantation (HSCT).

"The publication of the results in this highly respected medical journal is a testament to the medical importance of the emapalumab findings for patients with primary HLH," says Milan Zdravkovic, Head of Research & Development and Chief Medical Officer at Sobi. "The results further advance our understanding of primary HLH and the role of interferon gamma in its pathogenesis. Our hope is to contribute to the improvement of care and treatment for patients suffering from this potentially fatal disease."

The results with emapalumab in primary HLH published in the New England Journal of Medicine highlight the overall response rate of 63 percent in previously treated patients at the end of up to 8 weeks of treatment (compared to the pre-specified null hypothesis of 40 percent (p=0.02)). In the previously treated group, 70 percent of patients were able to proceed to transplantation. The most commonly reported adverse reactions ( 20 per cent) were infections, hypertension, infusion-related reactions and fever.

Michael Jordan, Professor of Pediatrics at the Cincinnati Children's Hospital Medical Center in the US and coordinating Principal Investigator of the study (US), confirms the importance of making advances in finding new therapies for HLH and emphasises the importance of the publication of the results: "The findings from the study are encouraging for those affected by this devastating disease."

Professor Franco Locatelli, Head of the Department of Onco-Haematology, Bambino Ges Children's Hospital IRCCS, Sapienza University of Rome, Italy, and coordinating Principal Investigator (EU), adds: "Emapalumab represents a prototype model molecularly targeted therapy and an important step towards improving outcomes for this severe and life-threatening disease."

This pivotal clinical study is the first study in primary HLH to prospectively assess and report treatment responses using predefined comprehensive objective clinical and laboratory criteria. Preclinical data have shown the central role of interferon gamma (IFN) in the pathogenesis of this disease1. Emapalumab is a monoclonal antibody that binds to and neutralises IFN. It was approved by the US Food & Drug Administration (FDA) on the basis of this clinical study for the treatment of primary HLH in adult and paediatric (newborn and older) patients with refractory, recurrent or progressive disease, or intolerance to conventional HLH therapy, and received Breakthrough Designation prior to review.

About emapalumab

Emapalumab is a monoclonal antibody that binds to and neutralises interferon gamma (IFN). In the US, emapalumab is indicated for paediatric (newborn and older) and adult primary haemophagocytic lymphohistiocytosis (HLH) patients with refractory, recurrent or progressive disease, or intolerance to conventional HLH therapy. Emapalumab is the first and only medicine approved in the US for primary HLH, a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. The FDA approval is based on data from the phase 2/3 studies (NCT01818492 and NCT02069899). Emapalumab is indicated for administration through intravenous infusion over one hour twice per week until haematopoietic stem cell transplantation (HSCT). For more information please see http://www.gamifant.com including the full US Prescribing Information. Emapalumab is under review for primary HLH by the European Medicines Agency (EMA).

About SobiTM

Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Sobi is providing sustainable access to innovative therapies in the areas of haematology, immunology and specialty indications. Today, Sobi employs approximately 1,400 people across Europe, North America, the Middle East, Russia and North Africa. In 2019, Sobi's revenues amounted to SEK 14.2 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at sobi.com.

For more information please contactPaula Treutiger, Head of Communication & Investor Relations+ 46-733-666-599paula.treutiger@sobi.com

Linda Holmstrm,Corporate Communication & Investor Relations+46-708-734-095linda.holmstrom@sobi.com

1. Jordan et al. Blood 2004;104:735-43.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/swedish-orphan-biovitrum-ab/r/results-from-pivotal-phase-2-3-study-of-emapalumab-in-patients-with-primary-hlh-published-in-new-eng,c3105820

The following files are available for download:

View original content:http://www.prnewswire.com/news-releases/results-from-pivotal-phase-23-study-of-emapalumab-in-patients-with-primary-hlh-published-in-new-england-journal-of-medicine-301054583.html

SOURCE Swedish Orphan Biovitrum AB

Company Codes: Berlin:B6E, Bloomberg:SOBI@SS, ISIN:SE0000872095, LSE:0MTD, OTC-PINK:BIOVF, RICS:SOBI.ST, Stockholm:SOBI, Dusseldorf:B6E, Frankfurt:B6E, Stuttgart:B6E

COVID-19 Impact and Recovery Analysis | Global Cell Isolation Market 2020-2024 | Evolving Opportunities with Agilent Technologies Inc. and Becton,…

By adminMay 7, 2020Stem Cell Medical Center

LONDON--(BUSINESS WIRE)--The global cell isolation market size is expected to grow by USD 9.47 billion as per Technavio. This marks a significant market growth compared to the 2019 growth estimates due to the impact of the COVID-19 pandemic in the first half of 2020. Moreover, steady growth is expected to continue throughout the forecast period, and the market is expected to grow at a CAGR of almost 21%.

Request for Technavio's latest reports on directly and indirectly impacted markets

Market estimates include pre- and post-COVID-19 impact on the cell isolation market -

Download free sample report

With the spread of COVID-19, a global increase in R&D activities in AR and PB has been observed in the first half of 2020. Researches are being conducted on stem cell therapies to develop mesenchymal stem cell-based therapies. For instance, in March 2020, researchers from the University of North Texas Health Science Center initiated a clinical trial in China on more than 100 COVID-19 patients and administered injections of mesenchymal stem cells. The rise in such R&D activities is increasing the demand for cell isolation products, which will result in the growth of the cell isolation market during the forecast period.

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/global-cell-isolation-market-industry-analysis

The market is driven by the increasing prevalence of chronic diseases. In addition, product advances are anticipated to boost the growth of the cell isolation market.

With the growing incidence of chronic diseases globally, the applications of isolated human cells in research, drug development, and clinical trials are increasing. Cell isolation helps study the behavior of cells and their response to diseases and different drugs. Cell isolation tools are used in drug discovery to generate recombinant protein therapeutics, which can treat a variety of chronic diseases. Hence, the rising prevalence of chronic diseases will boost the need for cell-based therapies, which, in turn, will increase the demand for cell isolation tools.

Buy 1 Technavio report and get the second for 50% off. Buy 2 Technavio reports and get the third for free.

View market snapshot before purchasing

Major Five Cell Isolation Companies:

Agilent Technologies Inc.

Agilent Technologies Inc. has business operations under various segments, such as life sciences and applied markets, diagnostics and genomics, and Agilient CrossLab. The company offers various consumables and instruments for cell isolation procedures.

Becton, Dickinson and Co.

Becton, Dickinson and Co. operates its business through various segments, such as BD Medical, BD Life Sciences, and BD Interventional. The company provides consumables and instruments for cell isolation procedures.

Bio-Rad Laboratories Inc.

Bio-Rad Laboratories Inc. has business operations under two segments: life science and clinical diagnostics. The company provides consumables and instruments for cell isolation procedures.

Danaher Corp.

Danaher Corp. operates its business through various segments, such as life sciences, diagnostics, and environment & applied solutions. The company provides consumables and instruments for cell isolation procedures.

F. Hoffmann-La Roche Ltd.

F. Hoffmann-La Roche Ltd. has business operations under two segments: pharmaceuticals and diagnostics. The company provides consumables and instruments for cell isolation procedures.

Technavio's SUBSCRIPTION platform

Cell Isolation Market Product Outlook (Revenue, USD bn, 2020-2024)

Cell Isolation Market Geography Outlook (Revenue, USD bn, 2020-2024)

Technavios sample reports are free of charge and contain multiple sections of the report, such as the market size and forecast, drivers, challenges, trends, and more. Request a free sample report

About Technavio

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.

View post:
COVID-19 Impact and Recovery Analysis | Global Cell Isolation Market 2020-2024 | Evolving Opportunities with Agilent Technologies Inc. and Becton,...

Stem Cell Alopecia Treatment Market Detailed Analysis of Current Industry Figures With Forecasts Growth by 2026 – 3rd Watch News

By adminMay 7, 2020Stem Cell Medical Center

Stem Cell Alopecia Treatment Market Trends, Size, Shares, Growth, Top Companies, Development, Application, Importance, Overview with Detailed Analysis, Production, Supply, Revenue, Regional Outlook, Status, Competitive Landscape, Future Forecast, Type and End-User, Opportunity, Demand, Historical Data, Business Insights, Research Methodology and many more

Due to the pandemic, we have included a special section on the Impact of COVID 19 on the Stem Cell Alopecia Treatment Market which would mention How the Covid-19 is Affecting the Stem Cell Alopecia Treatment Industry, Market Trends and Potential Opportunities in the COVID-19 Landscape, Covid-19 Impact on Key Regions and Proposal for Stem Cell Alopecia Treatment Players to Combat Covid-19 Impact.

Stem Cell Alopecia Treatment research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers, and challenges.

Top Key Players of the Global Stem Cell Alopecia Treatment Market:APEX Biologix, Belgravia Center, Kerastem, Riken Research Institute, RepliCel, Sanford Burnham Prebys Medical Discovery Institute,

Download Full PDF Sample Copy of Stem Cell Alopecia Treatment Report: (Including Full TOC, List of Tables & Figures, Chart) : https://www.qyresearch.com/sample-form/form/1491764/global-stem-cell-alopecia-treatment-market

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

* Top Key Company Profiles.* Main Business and Rival Information* SWOT Analysis and PESTEL Analysis* Production, Sales, Revenue, Price and Gross Margin* Market Share and Size

Global Stem Cell Alopecia Treatment Market is estimated to reach xxx million USD in 2019 and projected to grow at the CAGR of xx% during 2019-2025. According to the latest report added to the online repository of QY Research the Stem Cell Alopecia Treatment market has witnessed an unprecedented growth till 2019. The extrapolated future growth is expected to continue at higher rates by 2025.

Stem Cell Alopecia Treatment Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Get Full Customize report now at: https://www.qyresearch.com/customize-request/form/1491764/global-stem-cell-alopecia-treatment-market

Critical questions addressed by the Stem Cell Alopecia Treatment Market report

What are the key market drivers and restraints?What will be the market size until the end of the forecast period?Which segment is expected to take the lions share?Which region will lead the global Stem Cell Alopecia Treatment market in terms of growth?What will be the key strategies adopted by market leaders in future?What are the upcoming applications?How will the global Stem Cell Alopecia Treatment market develop in the mid to long term?

Table of Contents

1 Stem Cell Alopecia Treatment Market Overview1.1 Stem Cell Alopecia Treatment Product Overview1.2 Stem Cell Alopecia Treatment Market Segment by Type1.2.1 Cloud Service Orchestration1.2.2 API Management1.2.3 Application Integration1.2.4 B2B and Cloud Integration1.2.5 Data Integration1.3 Global Stem Cell Alopecia Treatment Market Size by Type1.3.1 Global Stem Cell Alopecia Treatment Sales and Growth by Type1.3.2 Global Stem Cell Alopecia Treatment Sales and Market Share by Type (2014-2019)1.3.3 Global Stem Cell Alopecia Treatment Revenue and Market Share by Type (2014-2019)1.3.4 Global Stem Cell Alopecia Treatment Price by Type (2014-2019)

2 Global Stem Cell Alopecia Treatment Market Competition by Company2.1 Global Stem Cell Alopecia Treatment Sales and Market Share by Company (2014-2019)2.2 Global Stem Cell Alopecia Treatment Revenue and Share by Company (2014-2019)2.3 Global Stem Cell Alopecia Treatment Price by Company (2014-2019)2.4 Global Top Players Stem Cell Alopecia Treatment Manufacturing Base Distribution, Sales Area, Product Types2.5 Stem Cell Alopecia Treatment Market Competitive Situation and Trends2.5.1 Stem Cell Alopecia Treatment Market Concentration Rate2.5.2 Global Stem Cell Alopecia Treatment Market Share of Top 5 and Top 10 Players2.5.3 Mergers & Acquisitions, Expansion

3 Stem Cell Alopecia Treatment Company Profiles and Sales Data3.1 IBM3.1.1 Company Basic Information, Manufacturing Base and Competitors3.1.2 Stem Cell Alopecia Treatment Product Category, Application and Specification3.1.3 IBM Stem Cell Alopecia Treatment Sales, Revenue, Price and Gross Margin(2014-2019)3.1.4 Main Business Overview3.2 Microsoft3.2.1 Company Basic Information, Manufacturing Base and Competitors3.2.2 Stem Cell Alopecia Treatment Product Category, Application and Specification3.2.3 Microsoft Stem Cell Alopecia Treatment Sales, Revenue, Price and Gross Margin(2014-2019)3.2.4 Main Business Overview3.3 Oracle3.3.1 Company Basic Information, Manufacturing Base and Competitors3.3.2 Stem Cell Alopecia Treatment Product Category, Application and Specification3.3.3 Oracle Stem Cell Alopecia Treatment Sales, Revenue, Price and Gross Margin(2014-2019)3.3.4 Main Business Overview3.4 Software3.4.1 Company Basic Information, Manufacturing Base and Competitors3.4.2 Stem Cell Alopecia Treatment Product Category, Application and Specification3.4.3 Software Stem Cell Alopecia Treatment Sales, Revenue, Price and Gross Margin(2014-2019)3.4.4 Main Business Overview3.5 TIBCO Software3.5.1 Company Basic Information, Manufacturing Base and Competitors3.5.2 Stem Cell Alopecia Treatment Product Category, Application and Specification3.5.3 TIBCO Software Stem Cell Alopecia Treatment Sales, Revenue, Price and Gross Margin(2014-2019)3.5.4 Main Business Overview3.6 Accenture3.6.1 Company Basic Information, Manufacturing Base and Competitors3.6.2 Stem Cell Alopecia Treatment Product Category, Application and Specification3.6.3 Accenture Stem Cell Alopecia Treatment Sales, Revenue, Price and Gross Margin(2014-2019)3.6.4 Main Business Overview3.7 Adeptia3.7.1 Company Basic Information, Manufacturing Base and Competitors3.7.2 Stem Cell Alopecia Treatment Product Category, Application and Specification3.7.3 Adeptia Stem Cell Alopecia Treatment Sales, Revenue, Price and Gross Margin(2014-2019)3.7.4 Main Business Overview3.8 Atos3.8.1 Company Basic Information, Manufacturing Base and Competitors3.8.2 Stem Cell Alopecia Treatment Product Category, Application and Specification3.8.3 Atos Stem Cell Alopecia Treatment Sales, Revenue, Price and Gross Margin(2014-2019)3.8.4 Main Business Overview3.9 Axway3.9.1 Company Basic Information, Manufacturing Base and Competitors3.9.2 Stem Cell Alopecia Treatment Product Category, Application and Specification3.9.3 Axway Stem Cell Alopecia Treatment Sales, Revenue, Price and Gross Margin(2014-2019)3.9.4 Main Business Overview3.10 BT Global Services3.10.1 Company Basic Information, Manufacturing Base and Competitors3.10.2 Stem Cell Alopecia Treatment Product Category, Application and Specification3.10.3 BT Global Services Stem Cell Alopecia Treatment Sales, Revenue, Price and Gross Margin(2014-2019)3.10.4 Main Business Overview

4 Stem Cell Alopecia Treatment Market Status and Outlook by Regions4.1 Global Market Status and Outlook by Regions4.1.1 Global Stem Cell Alopecia Treatment Market Size and CAGR by Regions4.1.2 North America4.1.3 Asia-Pacific4.1.4 Europe4.1.5 South America4.1.6 Middle East and Africa4.2 Global Stem Cell Alopecia Treatment Sales and Revenue by Regions4.2.1 Global Stem Cell Alopecia Treatment Sales and Market Share by Regions (2014-2019)4.2.2 Global Stem Cell Alopecia Treatment Revenue and Market Share by Regions (2014-2019)4.2.3 Global Stem Cell Alopecia Treatment Sales, Revenue, Price and Gross Margin (2014-2019)4.3 North America Stem Cell Alopecia Treatment Sales, Revenue, Price and Gross Margin4.3.1 United States4.3.2 Canada4.3.3 Mexico4.4 Europe Stem Cell Alopecia Treatment Sales, Revenue, Price and Gross Margin4.4.1 Germany4.4.2 UK4.4.3 France4.4.4 Italy4.4.5 Russia4.4.6 Turkey4.5 Asia-Pacific Stem Cell Alopecia Treatment Sales, Revenue, Price and Gross Margin4.5.1 China4.5.2 Japan4.5.3 Korea4.5.4 Southeast Asia4.5.4.1 Indonesia4.5.4.2 Thailand4.5.4.3 Malaysia4.5.4.4 Philippines4.5.4.5 Vietnam4.5.5 India4.5.6 Australia4.6 South America Stem Cell Alopecia Treatment Sales, Revenue, Price and Gross Margin4.6.1 Brazil4.7 Middle East and Africa Stem Cell Alopecia Treatment Sales, Revenue, Price and Gross Margin4.7.1 Egypt4.7.2 GCC Countries

5 Stem Cell Alopecia Treatment Application/End Users5.1 Stem Cell Alopecia Treatment Segment by Application5.1.1 Banking, Financial Services, and Insurance5.1.2 Consumer Goods and Retail5.1.3 Education5.1.4 Government and Public Sector5.1.5 Healthcare and Life Sciences5.1.6 Manufacturing5.1.7 Media and Entertainment5.1.8 Telecommunication and Ites5.1.9 Others5.2 Global Stem Cell Alopecia Treatment Product Segment by Application5.2.1 Global Stem Cell Alopecia Treatment Sales by Application5.2.2 Global Stem Cell Alopecia Treatment Sales and Market Share by Application (2014-2019)

6 Global Stem Cell Alopecia Treatment Market Forecast6.1 Global Stem Cell Alopecia Treatment Sales, Revenue Forecast (2019-2025)6.1.1 Global Stem Cell Alopecia Treatment Sales and Growth Rate Forecast (2019-2025)6.1.1 Global Stem Cell Alopecia Treatment Revenue and Growth Rate Forecast (2019-2025)6.2 Global Stem Cell Alopecia Treatment Forecast by Regions6.2.1 North America Stem Cell Alopecia Treatment Sales and Revenue Forecast (2019-2025)6.2.2 Europe Stem Cell Alopecia Treatment Sales and Revenue Forecast (2019-2025)6.2.3 Asia-Pacific Stem Cell Alopecia Treatment Sales and Revenue Forecast (2019-2025)6.2.3.1 China6.2.3.2 Japan6.2.3.3 Korea6.2.3.4 Southeast Asia6.2.3.5 India6.2.3.6 Australia6.2.4 South America Stem Cell Alopecia Treatment Sales and Revenue Forecast (2019-2025)6.2.5 Middle East and Africa Stem Cell Alopecia Treatment Sales and Revenue Forecast (2019-2025)6.2.5.1 Egypt6.2.5.2 GCC Countries6.3 Stem Cell Alopecia Treatment Forecast by Type6.3.1 Global Stem Cell Alopecia Treatment Sales and Revenue Forecast by Type (2019-2025)6.3.2 Cloud Service Orchestration Gowth Forecast6.3.3 API Management Gowth Forecast6.4 Stem Cell Alopecia Treatment Forecast by Application6.4.1 Global Stem Cell Alopecia Treatment Sales Forecast by Application (2019-2025)6.4.2 Global Stem Cell Alopecia Treatment Forecast in Banking, Financial Services, and Insurance6.4.3 Global Stem Cell Alopecia Treatment Forecast in Consumer Goods and Retail

7 Stem Cell Alopecia Treatment Upstream Raw Materials7.1 Stem Cell Alopecia Treatment Key Raw Materials7.1.1 Key Raw Materials7.1.2 Key Raw Materials Price7.1.3 Raw Materials Key Suppliers7.2 Manufacturing Cost Structure7.2.1 Raw Materials7.2.2 Labor Cost7.2.3 Manufacturing Expenses7.3 Stem Cell Alopecia Treatment Industrial Chain Analysis

8 Marketing Strategy Analysis, Distributors8.1 Marketing Channel8.1.1 Direct Marketing8.1.2 Indirect Marketing8.1.3 Marketing Channel Development Trend8.2 Distributors8.3 Downstream Customers

9 Research Findings and Conclusion

AppendixMethodology/Research ApproachResearch Programs/DesignMarket Size EstimationMarket Breakdown and Data TriangulationData SourceSecondary SourcesPrimary SourcesDisclaimer

About Us:

QYResearch always pursuits high product quality with the belief that quality is the soul of business. Through years of effort and supports from huge number of customer supports, QYResearch consulting group has accumulated creative design methods on many high-quality markets investigation and research team with rich experience. Today, QYResearch has become the brand of quality assurance in consulting industry.

Originally posted here:
Stem Cell Alopecia Treatment Market Detailed Analysis of Current Industry Figures With Forecasts Growth by 2026 - 3rd Watch News

BrainStorm Leases a New Cleanroom Facility at The Tel Aviv Sourasky Medical Center to Manufacture NurOwn for The European Union – BioSpace

By adminMay 7, 2020Adult Stem Cells

NEW YORK, N.Y., and TEL AVIV, Israel, May 07, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today a lease agreement with the Tel Aviv Sourasky Medical Center (Sourasky) in Tel Aviv, Israel, to produce NurOwn in three state-of-the-art cleanrooms. The new facility will significantly increase the Companys capacity to manufacture and ship its product into the European Union and the local Israeli market. The cleanroom facility is part of Souraskys Institute for Advanced Cellular Therapies.

"Sourasky Hospital is a leader in the advancement and manufacturing of cell and gene therapy products and is well-equipped to rapidly scale up and produce NurOwn," stated Prof. Ronni Gamzu, CEO of Tel Aviv Sourasky Medical Center. "We look forward to continuing our work with BrainStorm to bring NurOwn to ALS patients and help fulfill the clinical therapy demands for the Companys pipeline programs.

"Sourasky Hospital, known for introducing pioneering solutions into clinical practice and advancing patient care, has a first rate team with the proven experience to produce regenerative products in accordance to the highest standard of cGMP manufacturing," said Chaim Lebovits, CEO of BrainStorm. "This agreement will ensure that we can provide NurOwn to patients after regulatory approval, not only in Israel but we have secured capacity to rapidly scale up production as we advance our investigational treatment across the European Union. We are very pleased to be able to expand our ongoing collaboration with Sourasky Hospital, one of the worlds most innovative and respected medical centers."

About NurOwn NurOwn (autologous MSC-NTF) cells represent 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. 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. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

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 (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at http://www.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, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms 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 BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms 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 at http://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.

CONTACTS

Investor Relations:Preetam Shah, MBA, PhDChief Financial OfficerBrainStorm Cell Therapeutics Inc.Phone: + 1.862.397.1860pshah@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

See the rest here:
BrainStorm Leases a New Cleanroom Facility at The Tel Aviv Sourasky Medical Center to Manufacture NurOwn for The European Union - BioSpace

Stem Cells Market 2020 Size, Global Trends, Comprehensive Research Study, Development Status, Opportunities, Future Plans, Competitive Landscape and…

By adminMay 7, 2020Adult Stem Cells

Global Stem Cells Market 2020 Global Industry report covers the latest market statistics, industry growth driving factors, size, share, trends, as well as Forecast till 2026. The Global Industrial Stem Cells market analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status.

Get a Sample Copy of the Report https://www.marketreportsworld.com/enquiry/request-sample/15567294

Stem cells are a class of undifferentiated cells that are able to differentiate into specialized cell types. Commonly, stem cells come from two main sources: Embryos formed during the blastocyst phase of embryological development (embryonic stem cells) and Adult tissue (adult stem cells).Both types are generally characterized by their potency, or potential to differentiate into different cell types (such as skin, muscle, bone, etc.).Since the COVID-19 virus outbreak in December 2019, the disease has spread to almost 100 countries around the globe with the World Health Organization declaring it a public health emergency. The global impacts of the coronavirus disease 2019 (COVID-19) are already starting to be felt, and will significantly affect the Stem Cells market in 2020.COVID-19 can affect the global economy in three main ways: by directly affecting production and demand, by creating supply chain and market disruption, and by its financial impact on firms and financial markets.The outbreak of COVID-19 has brought effects on many aspects, like flight cancellations; travel bans and quarantines; restaurants closed; all indoor events restricted; over forty countries state of emergency declared; massive slowing of the supply chain; stock market volatility; falling business confidence, growing panic among the population, and uncertainty about future.

To know How COVID-19 Pandemic Will Impact This Market/Industry Request a sample copy of the report https://www.marketreportsworld.com/enquiry/request-covid19/15567294

COVID-19 can affect the global economy in three main ways: by directly affecting production and demand, by creating supply chain and market disruption, and by its financial impact on firms and financial markets. The outbreak of COVID-19 has brought effects on many aspects, like flight cancellations; travel bans and quarantines; restaurants closed; all indoor events restricted; over forty countries state of emergency declared; massive slowing of the supply chain; stock market volatility; falling business confidence, growing panic among the population, and uncertainty about future.

Global Stem Cells market competition by top manufacturers, with production, price, revenue (value) and market share for each manufacturer; the TOP PLAYERS including;

For the data information by region, company, type, and application, 2020 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

Enquire Before Purchasing this Report https://www.marketreportsworld.com/enquiry/pre-order-enquiry/15567294

The Stem Cells Market report examines competitive scenario by analyzing key players in the market. The company profiling of leading market players is included in this report with Porters five forces analysis and Value Chain analysis. Further, the strategies exercised by the companies for expansion of business through mergers, acquisitions, and other business development measures are discussed in the report. The financial parameters which are assessed include the sales, profits and the overall revenue generated by the key players of Market.

Stem Cells Breakdown Data by Type:

Stem Cells Breakdown Data by Application:

Purchase this Report (Price USD 3900 for Single User License) https://www.marketreportsworld.com/purchase/15567294

Stem Cells Market by Regions:

Key questions answered in the report:

Highlights of the report which will influence the Stem Cells market:

Major Points from Table of Contents:

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered1.4 Market Analysis by Type1.4.1 Global Stem Cells Market Size Growth Rate by Type (2015-2026)1.4.2 Major-Type1.4.3 Independent-Type1.4.4 Administrator-Type1.5 Market by Application1.5.1 Global Stem Cells Market Share by Application (2015-2026)1.5.2 Commercial1.5.3 Commonweal1.5.4 Other1.6 Study Objectives1.7 Years Considered

2 Global Growth Trends2.1 Stem Cells Market Size2.2 Stem Cells Growth Trends by Regions2.2.1 Stem Cells Market Size by Regions (2015-2026)2.2.2 Stem Cells Market Share by Regions (2015-2020)2.3 Industry Trends2.3.1 Market Top Trends2.3.2 Market Drivers2.3.3 Market Opportunities

3 Market Share by Key Players3.1 Stem Cells Market Size by Manufacturers3.1.1 Global Stem Cells Revenue by Manufacturers (2015-2020)3.1.2 Global Stem Cells Revenue Market Share by Manufacturers (2015-2020)3.1.3 Global Stem Cells Market Concentration Ratio (CR5 and HHI)3.2 Stem Cells Key Players Head office and Area Served3.3 Key Players Stem Cells Product/Solution/Service3.4 Date of Enter into Stem Cells Market3.5 Mergers & Acquisitions, Expansion Plans

4 Breakdown Data by Type and Application4.1 Global Stem Cells Market Size by Type (2015-2020)4.2 Global Stem Cells Market Size by Application (2015-2020)

(5, 6, 7, 8, 9, 10, 11) United States, Europe, China, Japan, Southeast Asia, India, Central & South AmericaStem Cells Market Size (2015-2020)Key PlayersStem Cells Market Size by TypeStem Cells Market Size by Application

12 International Players ProfilesCompany DetailsCompany Description and Business OverviewStem Cells IntroductionRevenue in Stem Cells Business (2015-2020)Recent Development

13 Market Forecast 2020-202613.1 Market Size Forecast by Regions13.2 United States13.3 Europe13.4 China13.5 Japan13.6 Southeast Asia13.7 India13.8 Central & South America13.9 Market Size Forecast by Product (2020-2026)13.10 Market Size Forecast by Application (2020-2026)

14 Analysts Viewpoints/Conclusions

15 Appendix15.1 Research Methodology15.1.1 Methodology/Research Approach15.1.1.1 Research Programs/Design15.1.1.2 Market Size Estimation12.1.1.3 Market Breakdown and Data Triangulation15.1.2 Data Source15.1.2.1 Secondary Sources15.1.2.2 Primary Sources15.2 Disclaimer15.3 Author Details

About Us:

Market is changing rapidly with the ongoing expansion of the industry. Advancement in the technology has provided todays businesses with multifaceted advantages resulting in daily economic shifts. Thus, it is very important for a company to comprehend the patterns of the market movements in order to strategize better. An efficient strategy offers the companies with a head start in planning and an edge over the competitors. Market Reports World is the credible source for gaining the market reports that will provide you with the lead your business needs.

Name: Mr. Ajay More

Email: [emailprotected]

Phone: US +1408 520 9750 / UK +44 203 239 8187

Other Reports Here:

Anti-drone Market 2020-Global Industry Trends, Share, Growth Insight, Size, Competitive Analysis, Statistics, Regional, And Global Forecast To 2023

Light Cure Adhesive Market 2020 Industry Size by Global Major Companies Profile, Competitive Landscape and Key Regions 2025 | Market Reports World

Industrial Fastener Seal Market Size, Share 2020 Regional Trend, Future Growth, Leading Players Updates, Industry Demand, Current and Future Plans by Forecast to 2022

Industrial Motor Busbar Market 2020 Globally Market Size, Analysis, Share, Research, Business Growth and Forecast to 2024 | Market Reports World

Computational Fluid Dynamics (CFD) Market Size, Share 2020 Global Business Growth, Trend, Segmentation, Top Key Players Analysis Industry, Opportunities and Forecast to 2024

Polyamide Resins Market Size, Share 2020|Global Trends, Industry Share, Growth Drivers, Business Opportunities and Demand Forecast to 2023

Medical Marijuana Market Size, Share 2020-Global Industry Trends, Growth Insight, Competitive Analysis, Statistics, Regional, And Global Forecast To 2024

Womens Footwear Market Size, Share Growth Opportunities, Driving Factors by Manufacturers, Regions, Type and Application, Revenue Market Forecast 2026

More:
Stem Cells Market 2020 Size, Global Trends, Comprehensive Research Study, Development Status, Opportunities, Future Plans, Competitive Landscape and...

Chinas scientists accused of playing God by creating monstrous cloned apes and primates with human organs – The Sun

By adminMay 7, 2020Adult Stem Cells

CHINESE scientists have been accused of being real-life Dr Frankensteins who play God by cloning apes and editing the genes of babies.

Some of their work has been dubbed monstrous while other cutting edge research could lead to cures for Parkinson's and Alzheimer's.

It's important to note that the US and the UK are not immune from conducting tests on animals and in fact carry out THOUSANDS of experiments on primates every year.

However, China has become the capital of research on apes and monkeys believing that our closest relatives hold the key to understanding brain disorders that destroy lives.

Incredibly, the Institute of Neuroscience (ION) in Shanghai, cloned five infant monkeys last year from an adult macaque who had been genetically-edited.

The result was baby primates intentionally born with a mutation that disrupts their wake-sleep cycle.

By giving the monkeys new drugs to treat their pre-existing brain disorders, the scientists hope to develop treatments for illnesses such as Alzheimer's disease.

It's no wonder the ION has been dubbed the "Cern of primate neurobiology".

The Institute successfully cloned two macaque monkeys in 2018 - a world first giving the experts confidence to push ahead with further experiments.

Heaping praise on the research, the Chinese Academy of Sciences said: "The achievement heralds a new era in which China can produce batches of standardised monkey clones, which will serve as animal models in the research of the brain's cognitive functions, early diagnoses and interventions of diseases, as well as research and development of drugs.

While China allows genetic manipulation on animals it has banned the use of gene-editing on humans but that hasn't stopped some of its scientists "playing God" with unborn children.

Scientist He Jiankui, 35, rocked the scientific world when he revealed he had altered the embryos of twin girls in 2018.

In December last year, it was revealed that a third child born to a different mum had also been gene-edited.

The rogue expert said he used a tool called Crispr to disable a gene that allows the AIDS virus to enter cells in a bid to make the children immune from the disease.

But why have such experiments been dubbed monstrous by others within the scientific community?

Experts claim gene-editing in people could "divide humans into subspecies" and can cause mutations, genetic problems and even cancer.

Dr Kiran Musunuru, an expert in this area from the University of Pennsylvania, called the experiment unconscionable an experiment on human beings that is not morally or ethically defensible.

Professor Julian Savulescu, of the University of Oxford, said: If true, this experiment is monstrous.

The embryos were healthy. No known diseases. Gene editing itself is experimental and is still associated with off-target mutations, capable of causing genetic problems early and later in life, including the development of cancer.

There are many effective ways to prevent HIV in healthy individuals: for example, protected sex.

Last December, Mr Jiankui was jailed for three years after news of the third child's birth was revealed.

He was convicted of practising medicine without a licence and fined 330,000 by a court in Shenzhen, the Xinhua news agency reported.

One of the most controversial experiments to date was the creation of embryos that were part human and part primate.

Last year, Spaniard Juan Carlos Izpisa Belmonte led a team of Chinese researchers with the end goal of creating monkeys which have entirely human organs such as kidneys or livers.

The organs will then be used for human transplants.

Based in China, the team made the chimeras a single organism with cells from more than one genotype - by injecting human stem cells into a fresh monkey embryo.

Biologist Belmonte previously tried adding human cells to embryos of pigs but the disturbing experiment was not successful.

However, because primates are genetically related to humans, the chances of the new research being successful is much greater.

The scientists also use gene-editing technology to disable certain cell formations in the animals to give the human cells a better chance of thriving.

In the US and other western democracies, such research is banned however in China, experts are allowed to push the boundaries of scientific ethics.

Importantly, no Frankenstein monster has been born as a result of this research... not yet anyway.

Instead, the hybrid embryos are allowed to develop for around two weeks so their progress can be studied.

Mr Belmonte defended his work with the Chinese, saying: History shows us time and time again that, over time, our ethical and moral standards change and mutate, like our DNA, and what yesterday was ethically unacceptable, if this really represents an advance for the progress of humanity, today it is already an essential part of our lives."

Live Blog

COVID CRISISCoronavirus UK LIVE: Lockdown extended by three weeks as nation claps for NHS

ANIMAL CRISISPets being abandoned over false virus claims animals can pass bug to humans

LET THE SUN SHINE25C Bank Holiday heatwave looks set to tempt Brits out of lockdown

Comment

DAN WOOTTONThe war gave us great young leaders...perhaps the coronavirus crisis will too

Latest

OPEN-AND-CUT CASESalon owner jailed for reopening during pandemic ordered to be RELEASED

LOUD & PROUDMillions of Brits clap and cheer our NHS heroes fighting virus on frontline

A similar experiment involved two piglets who were born with monkey cells in December at the State Key Laboratory of Stem Cell and Reproductive Biology in Beijing.

The so-called 'pig-monkey chimeras' died a week later.

Away from China, one of the most sinister experiments took place at the University of Munich where two monkeys were given transplanted pig hearts.

The poor creatures died after six months in a study which was deemed a success.

See more here:
Chinas scientists accused of playing God by creating monstrous cloned apes and primates with human organs - The Sun

AMC to use stem cell therapy in treating graft-versus-host disease – Korea Biomedical Review

By adminMay 7, 2020Stem Cell Medical Center

Korean researchers have found a signal transduction system that modulates the treatment of mesenchymal stem cells and immune control functions, opening the way for treating graft-versus-host disease treatment.

Mesenchymal stem cells divide into various cells, have immunomodulatory functions, and are the primary cell sources for stem cell therapy.

Graft-versus-host disease is a fatal disease that leads to death after an allogeneic blood transfusion or bone marrow transplantation. Although there are many clinical trials underway worldwide to treat the symptom, there are no applicable treatments besides alleviating symptoms with high-dose steroids.

The team, led by Professor Shin Dong-myeong of the Department of Biomedical Sciences at Asan Medical Center, discovered that the CREB1 (CAMP responsive element binding protein 1) signaling system activates the treatment and immune control functions of mesenchymal stem cells.

The team administered a therapeutic agent made by upgrading mesenchymal stem cells to graft-versus-host disease mice, and found that it alleviated anorexia symptoms and reduced the weight loss rate by 30 percent while increasing the survival rate by 30 percent.

When developing a cell therapy product, researchers have to cultivate the stem cells in vitro. Thus it is very likely that it will impair stem cell functions due to free radicals generated in the cells. To prevent the deterioration of stem cell function, it is necessary to improve the stem cell function in vitro culture, prevent stem cell oxidation, and increase the antioxidant capacity of the cell itself.

Until now, there was a lack of specific evidence and understanding of how stem cells regulate glutathione, an indicator of antioxidant capacity. Therefore, it was difficult to prevent stem cell dysfunction and oxidation.

Professor Shin's team developed experimental techniques that can monitor and quantify glutathione in real-time and confirmed that the CREB1 signaling system regulated the amount and activity of glutathione.

By activating the CREB1 signaling system, the team found that the process also activated nuclear factor erythroid 2-related factor 2 (NRF2) protein, which maintains the antioxidant capacity of mesenchymal stem cells and the increase of both the expression levels of peroxiredoxin-1 (PRDX1) and glutamate-cysteine ligase modifier subunit (GCLM) protein, which synthesize glutathione and are antioxidant activity indicators.

As a result, the team confirmed that its method was effective in treating the graft-versus-host disease.

"Based on this study, we have secured a technological foundation to advance stem cell treatment by controlling the antioxidant capacity of stem cells," Professor Shin said.

If this technology makes a high-purity and high-quality stem cell treatment, the team expects that it will be a step toward developing a graft-versus-host disease treatment and overcoming various intractable diseases such as nervous system diseases and inflammatory diseases with high medical demand, Shin added.

The results of the study were published in the journal, Science Advances.

corea022@docdocdoc.co.kr

Read the original here:
AMC to use stem cell therapy in treating graft-versus-host disease - Korea Biomedical Review

Drumming class finds a new rhythm with creative connections – Yes! Weekly

By adminMay 7, 2020Stem Cell Medical Center

Winston-Salem, N.C. When music professor John Becks Afro-Cuban drumming class moved online, his students didnt miss a beat even though only one of the 17 seniors in his class had access to a drum.

The global drum circle community on social media was quick to offer ideas for virtual groups. One video showed a friend of mine drumming on a picnic table and asking people to play his rhythm back, said Beck.

The students first assignment was based on that video.

I assembled their clips together and posted the recording so they could all see each other like we do in class when we are seated in a circle. One week I asked the students to send me their favorite song, and they recorded themselves drumming on buckets, tables, boxes and metal pots.

In an in-person class there is a sense of community, Beck explains. The group works together creating rhythm, smiling and enjoying the experience. But after spending time immersed in the video projects, looking at the student clips, watching them drum and assembling the projects on his computer, he felt he knew this class better than any other he has taught.

Beck recently completed a 22-month study at Wake Forest Baptist Medical Center with stem cell transplant recipients using a protocol developed called Comfort Sound drumming. During the patient drumming experience, researchers identified improvement in mood, energy and relaxation, and decreases in anxiety, distress and pain.

The video compilations were a way of being together through the music and my students expressed they felt similar benefits to the ones in our study. Our work together helped them cope with the stress of finishing their time at Wake Forest away from their friends and teachers.

Senior Lizzie Pittinger, a political science major, said continuing with the drumming exercises online was not only a fun way to stay connected with her classmates, but also created a sense of normalcy during this uncertain time. Despite the physical distance that I felt from my classmates as we were all learning from our own homes, the weekly assignments reminded me that we will always be able to connect by sharing experiences with each othereven if it has to be through Zoom for now!

Watch the video here.

###

About Wake Forest University:

Wake Forest University combines the best traditions of a small liberal arts college with the resources of a large research university. Founded in 1834, the school is located in Winston-Salem, N.C. The Universitys graduate school of arts and sciences, divinity school, and nationally ranked schools of law, medicine and business enrich our intellectual environment. Learn more about Wake Forest University at http://www.wfu.edu.

See the original post here:
Drumming class finds a new rhythm with creative connections - Yes! Weekly

Human Embryonic Stem Cells, Germ Cells, and Cell-Derived …

By adminMay 7, 2020Embryonic Stem Cells

NOTE: THIS GUIDANCE REPLACES OHRPS NOVEMBER 16, 2001, GUIDANCE ENTITLED, GUIDANCE FOR INVESTIGATORS AND INSTITUTIONAL REVIEW BOARDS REGARDING RESEARCH INVOLVING HUMAN EMBRYONIC STEM CELLS, GERM CELLS, AND CELL-DERIVED TEST ARTICLES. CLICK HERE FOR THE NOVEMBER 16, 2001 GUIDANCE.

Office for Human Research Protections Department of Health and Human Services

Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles

Date:March 19, 2002

Scope: This document describes when research activities involving human embryonic stem cells (hESCs), human embryonic germ cells derived from fetal tissue, or hESC- or germ cell-derived test articles are considered human subjects research and what regulatory controls apply to that research.

Target Audience: Investigators who conduct research with these cells and test articles, sponsors of such research, institutions where the research is conducted, and Institutional Review Boards (IRBs) that review human subject research involving these cells or test articles.

APPLICABLE REGULATIONS AND LAWS

CONDITIONS REGARDING FEDERAL FUNDING OF RESEARCH ON HUMAN EMBRYONIC STEM CELLS

GUIDANCE

Under HHS regulations at 45 CFR Part 46, human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

HHS-conducted or supported research that involves neither interactions nor interventions with living individuals or obtaining identifiable private information is not considered human subjects research. Accordingly, in vitro research and research in animals using already derived and established human cell lines, from which the identity of the donor(s) cannot readily be ascertained by the investigator, are not considered human subject research and are not governed by the HHS or FDA human subject protection regulations appearing at 45 CFR Part 46 and 21 CFR Parts 50 and 56. IRB review is not required for such research.

Use of Identifiable Private Information

HHS-conducted or supported research that uses human cell lines where the donor(s) may be identified, including cells that retain links (such as a code) to identifying information is generally considered human subject research that is governed by 45 CFR Part 46 because the donors are human subjects. IRB review and approval is required for such research.

In vitro research or research in animals using a human cell line that retains a link to identifying information ordinarily would not be considered human subjects research if: (1) the investigator and research institution do not have access to identifiable private information related to the cell line; and (2) a written agreement is obtained from the holder of the identifiable private information related to the cell line providing that such information will not be released to the investigator under any circumstances. In this case, the research may be considered to not involve human subjects because the identity of the donor(s) could not be readily ascertained by the investigator or associated with the cell line. Under such circumstances, an institution or an IRB could determine that IRB review of the research using the cell line was not needed.

Intervention or Interactions with the Individual

All HHS-conducted or supported clinical research that involves interactions with living individuals, including the transplantation of human cells or test articles, such as differentiated cells derived from human embryos or human fetal tissue, into human recipients is human subjects research subject to HHS regulations at 45 CFR Part 46 because recipients are human subjects. IRB review and approval is required for such research.

Furthermore, all clinical research involving use of cells or test articles regulated by FDA as drugs, devices, and biological products is subject to regulation and oversight by FDA. This clinical research must be conducted in compliance with FDAs regulations governing INDs or IDEs regardless of source of funding. All human studies conducted under INDs and IDEs are subject to FDAs IRB and informed consent regulations.

Public Law 103-43, Research on Transplantation of Fetal Tissue, also applies to clinical research involving the transplantation of cells or test articles derived from human fetal tissue into human recipients.

In addition, other Federal, State or local laws may also apply to transplantation or other research involving these cells or test articles.

RELATED GUIDANCE

For further information regarding this guidance, please contact OHRP at ohrp@hhs.gov or 240-453-6900).

Visit link:
Human Embryonic Stem Cells, Germ Cells, and Cell-Derived ...

Roeland Nusse receives Canada’s Gairdner International Award | The Dish – Stanford University News

By adminMay 7, 2020Adult Stem Cells

by Krista Conger on May 6, 2020 3:43 pm

ROELAND NUSSE, professor of developmental biology, has received Canadas Gairdner International Awardfor his work on understanding the role of the Wnt signaling pathway in normal development and in cancer.

The Wnt pathway is made up of proteins, including one called Wnt, that transmit signals from outside the cell to the inside to trigger biological functions including gene expression and cell division.

Roeland Nusse was honored with Canadas Gairdner International Award for his work on the Wnt signaling pathway, which plays an important role in normal development and in cancer. (Image credit: Norbert von der Groeben)

The award recognizes excellence in fundamental research that affects human health.

Recipients receive 100,000 Canadian dollars (about $72,000) to use as they wish; Nusse plans to donate his award toUNICEF to help provide protective equipment for health care workers caring for children amid the global COVID-19 pandemic. Nusse is the Reed-Hodgson Professor in Human Biology and the Virginia and Daniel K. Ludwig Professor in Cancer Research.

In 1982, Nusse collaborated withHarold Varmus, then a professor in microbiology and immunology at the University of California, San Francisco, to identify Wnt as a critical cancer-associated gene in a mouse model of breast cancer. Nusse went on to show that the analogous gene in fruit flies, Wingless, plays an important role in regulating normal development. The finding highlighted the connections between normal development and cancer.

More recently, Nusse has focused his research on understanding how Wnt signaling regulates the activity of tissue-specific adult stem cells in response to injury or disease. In 2016, Nusse was awarded a $3million Breakthrough Prizefor his work on Wnt signaling.

Read the full article on the Stanford Medicine website.

Originally posted here:
Roeland Nusse receives Canada's Gairdner International Award | The Dish - Stanford University News