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 possibly 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 interventions to realize the full potential of this field.

The 21st Century Cures Act, passed in December 2016, establishes a 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 FDA.

The Cures Act authorizes $30 million in federal awards over four years (2017–2020) for the RMIP. Importantly, the Act requires that award recipients match the federal award in at least an equal amount with non-federal funds, which will amplify the federal investment and could help stimulate collaboration and develop key partnerships across the public and private sectors.

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

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

Information about FY 2018 funding opportunities will be posted on our Funding Opportunities page.

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 science involving adult stem cells with a focus on approaches to the development of safe and effective products. The workshop agenda and speaker biographies are available. Video recordings from each session are also available.