Background

Cortical neurons derived from iPS cells.Cortical neurons derived from iPS cells: Red: neuronal marker TUJ1 (beta III tubulin). Green: cortical marker CUX-1. Blue: nuclear marker DAPI.NCATS intramural

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 technologies—such as engineered biomaterials and gene editing—to 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 (2017–2020) 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.

RMIP Activities

Two scientists observe ocular tissue samples under a laser scanning microscope.Two scientists observe ocular tissue samples under a laser scanning microscope.NEI intramural

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. After a competitive merit review process, several projects received funding in July 2019. These projects span a broad spectrum of science and new technologies, and have the potential to advance understanding and treatment of many diseases — including hemophilia, age-related macular degeneration, ischemic heart disease, emphysema, and chronic skin ulcers.

In August 2019, an FOA for a clinical trial cooperative agreement was published. Applications may be submitted between September 18 and October 18. For questions about this funding opportunity or about the RMIP, please consult the relevant program officer listed in the FOA, visit our Frequently Asked Questions page, or write to RMIP@nih.gov.