ISSCR News
The ISSCR Joins Coalition Letter in Support of ARPA-H Funding
The ISSCR joined over 100 biomedical research organizations and institutions to urge congressional appropriators to provide at least $1.5 billion for the Advanced Research Projects Agency for Health (ARPA-H). ARPA-H supports high-risk, high-reward biomedical research projects and was established in 2022 to complement the role of the National Institutes of Health. This investment would enable ARPA-H to continue supporting stem cell research and regenerative medicine projects aimed at advancing stem cell research and accelerating clinical breakthroughs.
The ISSCR Responds to FDA’s Draft Guidance on Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations
On 24 November, the ISSCR submitted comments on the Food and Drug Administration's draft guidance for Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations. ISSCR appreciates FDA’s willingness to consider alternative trial designs for cellular and gene therapy products. To support this effort, ISSCR requests additional guidance on managing manufacturing changes within adaptive or master protocols; decentralized trials for small populations; long-term follow-up; using surrogate endpoints and biomarkers; and trial design selection.
The ISSCR Commends Government of India on Pursuing Strengthened Regulatory Oversight of Cell- and Stem Cell-Derived Products
Last week, the ISSCR sent a letter to India’s Ministry of Health and Family Welfare commending the Government of India for pursuing draft amendments that would strengthen and clarify India’s regulatory framework for cell- and stem cell-derived products.
In the letter, shared in response to draft amendments to India’s Drugs Rules, 1945, the ISSCR notes the importance of rigorous regulatory review and manufacturing standards for cell- and stem cell-based products to protect patients.
The ISSCR Holds Second Meeting With UK Regulators on the Use of AI to Develop Stem Cell Therapies
The International Society for Stem Cell Research (ISSCR) held its second Broader Scope Scientific Advice meeting with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) on October 29, 2025, focusing on the use of artificial intelligence (AI) in developing stem cell therapies.
The session explored key topics including the current state and challenges of AI, machine learning, and digitalization systems for automation in cell and gene therapy; applications of AI in autologous iPSC-derived RPE cell therapy; and AI-based image analysis for in-process characterization and decision-making during iPSC generation.
The ISSCR Joins Coalition Letter in Support of NIH Funding
The ISSCR joined over 450 biomedical research organizations and institutions to urge U.S. congressional appropriators to provide the NIH for Fiscal Year 2026 no less than the $47.2 billion as approved by the Senate Appropriations Committee. This investment would enable the NIH to fund promising research and support the next generation of researchers. NIH-funded research leads to medical breakthroughs, provides hope for patients and families, and advances health.
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