ISSCR News
The ISSCR Responds to FDA’s Draft Guidance on Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations
On 24 November, the ISSCR submitted comments on the Food and Drug Administration's draft guidance for Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations.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.
The ISSCR Joins Letter Expressing Concerns Regarding Executive Order on Federal Grantmaking
The ISSCR joined more than 50 scientific societies to send a letter to U.S. congressional leaders expressing concerns over provisions in the recent Executive Order (EO) titled “Improving Oversight of Federal Grantmaking.” The letter details how E.O. provisions threaten the long-standing merit-based peer review system that has been the gold standard for supporting cutting-edge research and driving technological innovation. Provisions the letter highlights include those on shifting the review and selection of research awards to political appointees, expansion of “termination for convenience” authority over awarded grants, vague language regarding repeat grant recipients, and the prioritization of institutions with the lowest indirect cost rates. The letter urges Congress to provide necessary oversight at scientific agencies to prevent potentially significant damage to the federal scientific grantmaking process.
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