Policy

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.

The International Society for Stem Cell Research (ISSCR) has submitted a formal response to a Request for Information (RFI) issued by the National Institutes of Health (NIH) regarding its pause on new submissions to the NIH Human Embryonic Stem Cell (hESC) Registry and considerations to reduce reliance on hESCs in federally supported research.

‍Representing nearly 5,000 scientists, clinicians, ethicists, and industry leaders worldwide, the ISSCR underscores that continued investment in hESC research is essential to sustaining scientific progress and advancing life-saving therapies.

The ISSCR joined over 170 organizations representing scientists, physicians, and patient advocates in urging the U.S. Congress to reauthorize the Rare Pediatric Disease Priority Review Voucher (PRV) program. The PRV program provides a proven incentive for developing cell and gene therapies for children with rare diseases by driving private investment without additional taxpayer costs. The program has been successful in advancing research that addresses unmet clinical needs while strengthening the broader research and development ecosystem for cell and gene therapies.

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.