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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 and thereby 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 in the successful development of this field, NIH will lead the RMIP in coordination with that agency.
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 help stimulate collaboration across the public and private sector.
For FY 2017, Congress has allocated $2 million for the RMIP. To make optimal use of these funds, researchers are invited to submit applications for competitive revisions* that will support clinical research studies aimed at furthering the field of regenerative medicine involving adult stem cells. These revisions are expected to focus on innovative solutions to well-recognized challenges in the development of safe and effective regenerative medicine therapies.
Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of product manufacturing, quality, safety, or effectiveness. Eligible projects could include, but are not limited to, submission of a pre-Investigational New Drug (IND) or pre-Investigational New Device Exemption (IDE) package; submission of an IND/IDE application; or research conducted under an authorized IND or IDE.
As the RMIP progresses, additional information will be added to this site. Please visit frequently for updates.
*Eligible projects must be funded with the following types of awards: SBIR (R43/R44), STTR (R41/R42), U01, U54, UM1, UC4, U24, R01, R24, UM2, P41, and P50; see FOAs tab.