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Background

Regenerative medicine is an emerging area of science that holds great promise for treating and even curing a variety of injuries and diseases. Regenerative medicine includes using stem cells and other technologiessuch as engineered biomaterials and gene editingto repair or replace damaged cells, tissues, or organs. Stem cell-based approaches are under development in labs around the world, and some have already moved into clinical trials. Such progress notwithstanding, much work remains to be done toward the development of safe and effective regenerative medicine products and to realize the full potential of this field.

The 21st Century Cures Act, passed in December 2016, established the Regenerative Medicine Innovation Project (RMIP) to accelerate the field by supporting clinical research on adult stem cells while promoting the highest standards for carrying out scientific research and protecting patient safety. In recognition of the integral role of the Food and Drug Administration (FDA) in the successful development of this field, NIH is leading the RMIP in coordination with FDA.

The 21st Century Cures Act authorizes $30 million in federal awards over four years (20172020) for the RMIP. Importantly, the Act requires award recipients to match the federal funds provided with at least an equal amount of non-federal funds.This matching requirement will amplify the federal investment and could help stimulate collaboration and develop key partnerships across the public and private sectors.

Congress allocated $2 million for the RMIP in FY 2017. To make optimal use of these funds, researchers were invited to submit applications for competitive revisions to support clinical studies involving adult stem cells. Eight awards were issued in September 2017.

On December 6-7, 2017, the NIH and FDA hosted a public Regenerative Medicine Innovation Workshop that brought together key stakeholders to explore the state of regenerative medicine clinical research involving adult stem cells with a focus on approaches to the development of safe and effective products. Video recordings from each session are available. The deliberations at this workshop were instrumental in helping to identify some of the major needs, opportunities, and challenges in the regenerative medicine field.

Input from the workshop and other sources informed the development of the next round of funding opportunity announcements (FOAs) published in August 2018. These FOAs solicit new investigator-initiated projects, which may either involve a clinical trial or entail late stage Investigational New Drug (IND)- or Investigational Device Exemption (IDE)-enabling clinical research. Applicants who have questions about these opportunities may consult our Frequently Asked Questions, and those with additional questions are encouraged to either consult the relevant program officer listed in the FOA, or write to RMIP@nih.gov.

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