Limited Competition: Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UH3 Clinical Trial Optional)

The National Institutes of Health (NIH), under the Department of Health and Human Services (HHS), has announced a funding opportunity titled "Limited Competition: Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UH3 Clinical Trial Optional)." This opportunity, issued under the Funding Opportunity Number (FON) RFA-AR-25-014, is a reissue of RFA-HL-23-017. It is jointly administered by NIH Institutes including the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Eye Institute (NEI), and the National Heart, Lung, and Blood Institute (NHLBI). The program supports the continuation of clinical trials previously funded through the RMIP initiative, focusing on innovative regenerative medicine therapies using adult stem cells, as mandated by the 21st Century Cures Act. The program aims to continue clinical trial activities from initial RMIP awards. It welcomes proposals for extended analysis of enrolled patients, further exploration of collected data or biosamples, follow-up for long-term outcomes, or other value-adding studies. All projects must strictly use adult stem cells, excluding any of fetal or embryonic origin, and may involve biologics and biomaterials that aid host cell regeneration and function. Applications involving human embryonic or fetal stem cells are deemed non-responsive and will not be considered. The funding opportunity allocates up to $3.5 million across this and its companion NOFO (RFA-AR-25-013), with an anticipated issuance of up to five awards. Each award has a federal share cap of $400,000 per year in direct costs and a project period of up to two years. A key stipulation is a 1:1 non-federal cost match requirement, meaning applicants must contribute at least an equal amount to the federal funding, which can include cash, state/local government funds, or in-kind contributions such as staff time or equipment. Eligible applicants must be renewal applications from institutions previously awarded under RFA-HL-18-031, RFA-HL-20-030, or RFA-HL-21-003. A wide range of U.S.-based organizations are eligible, including higher education institutions, nonprofits, for-profits, and government entities. However, non-domestic organizations are not eligible to apply, although foreign components of U.S. organizations are permissible. Applications open on September 21, 2025, and must be submitted by October 21, 2025, by 5:00 PM local time. Applications must be submitted electronically via ASSIST, an institutional system-to-system solution, or Grants.gov Workspace, and tracked through eRA Commons. Applications that are incomplete or non-compliant with the stated requirements—including failure to include matching fund documentation—will not be reviewed. Evaluation criteria include the significance and innovation of the research, the rigor and feasibility of the approach, and the expertise and resources of the investigators and institutions. Projects will be scored based on their potential impact on the field of regenerative medicine. Contact points include Aron Marquitz (NIAMS), Rahul Thakar (NHLBI), and Donald Everett (NEI) for scientific inquiries. Financial questions can be directed to Timothy Edgerton (NIAMS), NHLBI’s grants office, or Karen Robinson Smith (NEI). This opportunity will expire on October 22, 2025.

Ensure matching fund documentation is detailed and valued accurately. Follow all NIH application instructions and NOFO-specific guidance.