Limited Competition: Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Studies (U01 Clinical Trial Not Allowed)

The National Institutes of Health (NIH), under the Department of Health and Human Services, has reissued its funding opportunity titled “Limited Competition: Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Studies (U01 Clinical Trial Not Allowed)” (Funding Opportunity Number: RFA-AR-25-013). This opportunity is a renewal cooperative agreement (U01) designed to advance regenerative medicine (RM) using adult stem cells and is part of NIH's efforts to fulfill statutory mandates outlined in the 21st Century Cures Act. The program is specifically for renewal applicants previously funded under RFA-HL-18-030 or RFA-HL-23-019. The purpose of the RMIP is to support late-stage preclinical studies aimed at generating data necessary for clinical development of RM therapies. These studies must continue the development of the same RM therapeutic solution from the original award. Proposed research must not involve embryonic or fetal stem cells and must include human subjects or materials of human origin. Acceptable projects include but are not limited to: in vivo cell tracking, cGMP compliant stem cell production, IND/IDE-enabling studies, and the development of tools and standards for stem cell characterization and manufacturing. Eligible applicants include a broad range of organizations such as higher education institutions, nonprofits with and without 501(c)(3) status, for-profit entities, and state and local governments. Foreign organizations are not eligible to apply, although foreign components within U.S. organizations may be included. Program directors/principal investigators must be associated with previously funded RMIP projects under the specified RFAs. All applicants must have active registrations with SAM, eRA Commons, and Grants.gov, including a unique entity identifier (UEI). The funding opportunity opens on September 21, 2025, with a submission deadline of October 21, 2025, by 5:00 PM local time. Awards will be announced no earlier than July 2026. Applications must adhere to the Research (R) Instructions in the NIH Application Guide and provide a detailed budget, including a required 1:1 cost match of federal funds with non-federal sources, such as state or private investments. Budgets must not exceed $400,000 in direct federal costs per year, and total project periods may last up to two years. NIH anticipates committing up to $3,500,000 in total funds across this and a companion NOFO. Applications are reviewed based on significance, innovation, approach, investigator expertise, and available resources. Priority is given to projects addressing regulatory science, safety, potency, and other key elements necessary for successful IND/IDE submissions. Applicants must provide letters of support confirming matching contributions and submit comprehensive data sharing plans, as well as participate in NIH’s In-Depth Cell Characterization efforts. Contacts for scientific and financial inquiries include Dr. Aron Marquitz (aron.marquitz@nih.gov), Dr. Rahul Thakar (rahul.thakar@nih.gov), Donald Everett (dfe@nei.nih.gov), and Karen Robinson Smith (kyr@nei.nih.gov). Application support is available through NIH’s eRA Service Desk and Grants.gov customer support.

Applicants should ensure alignment with prior RMIP focus and provide well-documented matching contributions.