ISSCR News
ISSCR Statement in Response to New NIH Policy on Research Using Human Fetal Tissue (NOT-OD-26-028)
The abrupt ending of NIH support for fetal tissue research will undermine the development of new therapies for diseases that affect American families. Research with human fetal tissue (HFT) and HFT-derived cell lines has been integral to biomedical progress for nearly a century and has long been supported on a bipartisan basis under many U.S. administrations. This research has contributed to fundamental advances in understanding human development, infertility, infectious diseases, and chronic and neurodegenerative conditions. HFT-derived cell lines have played a critical role in the development of vaccines that have saved millions of lives worldwide.
This research is also governed by a well-established ethical and legal framework that includes rigorous scientific review, robust informed consent, and prohibition of profit from tissue donation. While continued investment in alternative research models is important and should be encouraged, HFT remains a necessary tool for addressing certain research questions that cannot yet be adequately answered by organoids, tissue chips, and other emerging technologies.
The announcement of this immediate change to NIH policy without prior engagement with the scientific community and without advance notice for ongoing, peer-reviewed projects is highly disruptive. Engagement with researchers in advance of policy changes helps ensure that NIH’s decisions are grounded in the latest scientific evidence and that the agency is fully informed about which lines of research may be constrained or lost due to its changes in oversight. Immediate withdrawal of research support risks the loss of life-saving biomedical research and undermines responsible stewardship of public resources.
We urge reconsideration of this policy and call for NIH to engage constructively with the scientific community to support biomedical research that advances discovery and improves human health.
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.
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