ISSCR News
ISSCR Consortium Urges FDA to Maintain Flexible, Science-Driven Framework for New Approach Methodologies in Drug Development
The International Society for Stem Cell Research (ISSCR) Consortium on Advanced Stem Cell-Based Models in Drug Discovery and Development has submitted comments to the U.S. Food and Drug Administration (FDA) in response to the agency’s draft guidance, General Considerations for the Use of New Approach Methodologies in Drug Development Guidance for Industry.
The consortium, a global collaboration of academic scientists, industry leaders, and regulatory experts convened by the ISSCR, welcomed the FDA’s efforts to advance the integration of new approach methodologies (NAMs) into drug development while emphasizing the importance of maintaining a flexible, fit-for-purpose regulatory framework that can adapt to rapidly evolving technologies.
New Podcast Episode. Therapeutic Strategy for COVID-19-Induced Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) induced by COVID-19 was a leading cause of severe illness and death during the pandemic, driven by an intense innate immune response, hyperinflammation, and a decrease in lymphocytes. Mesenchymal stromal cells (MSCs) represent a potential therapeutic option for ARDS due to their ability to modulate the immune system and inflammation. Our guests report results from a Health Canada–regulated Phase I and Phase II trials evaluating freshly cultured umbilical cord–derived MSCs in patients with COVID-19-related ARDS, including assessments of safety, maximum feasible tolerated dose, and preliminary efficacy. Their work explores a therapeutic strategy to improve ARDS outcomes using MSCs, which will be important for optimizing and targeting future cellular therapies.
The World’s Most Groundbreaking Stem Cell Advances Are Coming to San Francisco for ISSCR 2027
The International Society for Stem Cell Research (ISSCR) today announced that the ISSCR 2027 Annual Meeting is coming back to San Francisco, USA, 15-18 June 2027. Recognized as the premier international forum for stem cell science, the gathering will recognize 25 years of discovery, collaboration, and progress in stem cell science and gather the people, ideas, and work that will shape the next quarter century.
The ISSCR Joins Coalition Letter in Support of the National Institutes of Health (NIH)
The ISSCR joined more than 110 organizations in the cell and gene therapy sector to urge congressional appropriators to provide at least $51.303 billion for the National Institutes of Health (NIH) for fiscal year 2027. This funding level would represent a robust investment in important biomedical research and a meaningful increase over enacted fiscal year 2026 levels. NIH funding remains foundational to the continued advancement of stem cell research. Strong support for NIH will ensure the continued translation of stem cell research into the clinic and to the lives of patients. In addition to the funding request, the letter urges the timely distribution of NIH funding to ensure biomedical research can continue without disruption.
Sustaining Progress in Stem Cell Science: From hESC Research to Emerging Ethical Frontiers
Only a month ago, it felt as though spring had finally arrived in many parts of the Northern Hemisphere. Here in Tokyo, where I live, the season has already moved forward, and the fresh green leaves now fill the city with a sense of renewal. At ISSCR, we are also entering a season of anticipation. The program for ISSCR 2026 is now nearly complete, and it has developed into a truly exciting meeting. I very much look forward to seeing many of you in person this July in Montréal.
At the same time, ISSCR’s work extends well beyond the preparation of our Annual Meeting. As one important example, we have been actively engaged in responding to the recent NIH Request for Information concerning the future use of human embryonic stem cells, or hESCs, in NIH-supported research. I would like to take this opportunity to share the central message of our response.
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