Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required) | RFA HL 21 003

Opportunity Information: Apply for RFA HL 21 003

The Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3, Clinical Trial Required) funding opportunity is an NIH cooperative agreement designed to push adult stem cell-based regenerative medicine interventions into well-planned human clinical testing. NIH is running this program in coordination with the U.S. Food and Drug Administration (FDA), and it is explicitly tied to the 21st Century Cures Act, which directed federal agencies to accelerate the development of safe and effective regenerative medicine therapies. In practice, this means the program is looking for clinical trial applications that are not only scientifically compelling, but also realistically executable and aligned with regulatory expectations.

A central feature of this opportunity is its two-stage (bi-phasic) structure and its milestone-driven design. The award uses the UG3/UH3 mechanism, which typically supports an initial start-up and readiness phase (UG3) followed by an expansion or execution phase (UH3) once predefined milestones are met. The milestones are not a formality; they are meant to enforce real accountability around clinical trial preparedness, operational capacity, and progress toward meaningful endpoints. Because this is a cooperative agreement rather than a standard grant, NIH program staff have a more active role than usual in overseeing progress and ensuring that the project stays aligned with the program goals, timelines, and required deliverables.

The FOA is specifically focused on regenerative medicine products that use adult stem cells, with an emphasis on interventions that have already completed appropriate product development and preclinical evaluation. In other words, applicants are expected to bring forward therapies that are genuinely ready to move into clinical trials, not early exploratory concepts. The program is interested in highly innovative projects that address well-recognized bottlenecks in the field, such as challenges related to product manufacturing consistency, potency and characterization, safety risks, delivery methods, and other translational barriers that commonly slow or derail regenerative medicine development.

On the clinical side, the FOA solicits Phase I and later-stage trials (Phase I and beyond). Applications are expected to present a strong scientific justification for testing the intervention in humans and to provide a detailed, credible operational plan for running the trial. NIH expects applicants to lay out trial logistics clearly, including how the study will be managed, how participants will be recruited and retained, what performance milestones will be used to track progress, how the intervention will be administered, how safety and outcomes will be monitored, and how the results will be analyzed and shared. The clinical trial must also fall within the mission of at least one of the participating NIH Institutes or Centers and must meet the NIH definition of a clinical trial (the FOA references NOT-OD-15-015 for that definition).

Regulatory readiness is a hard requirement for success under this program. Before an award can be made, and when applicable, the applicant must secure FDA authorization to administer the product to humans, either through an Investigational New Drug (IND) application for biologic/drug products or an Investigational Device Exemption (IDE) for device-based interventions. This requirement signals that NIH expects projects to be able to clear key regulatory hurdles and to have credible Chemistry, Manufacturing, and Controls (CMC) plans, clinical monitoring plans, and other documentation needed to satisfy FDA expectations for early human testing.

Another notable element is the expectation of transparency and independent assessment of the stem cell product. Successful applicants using adult stem cells as the clinical intervention will be asked to provide representative samples of both the original source stem cells and the clinical-grade, stem cell-derived product. These samples are intended for in-depth and independent evaluation, which reflects the broader RMIP goal of strengthening confidence in product quality, reproducibility, and safety across the regenerative medicine ecosystem.

In terms of who can apply, eligibility is broad across U.S.-based organizations. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and eligible federal agencies.

At the same time, the opportunity draws clear boundaries around foreign involvement. Non-domestic (non-U.S.) entities are not eligible to apply as applicant organizations, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined in NIH policy) are not allowed. In effect, the work supported by this FOA is intended to be conducted entirely within eligible U.S. organizational structures and locations.

Administrative details in the source information indicate this is an NIH discretionary funding opportunity issued as RFA-HL-21-003 using the cooperative agreement instrument. The original closing date listed is October 2, 2020, and the opportunity is associated with multiple CFDA numbers spanning NIH programs (including, for example, 93.121, 93.173, 93.233, and others), reflecting participation across multiple NIH Institutes and Centers rather than a single disease area. Overall, the funding opportunity is best understood as a translational, execution-focused pathway for adult stem cell regenerative medicine products that are ready for clinical testing, with strong emphasis on regulatory clearance, rigorous trial operations, milestone-based progress, and credible dissemination of clinical findings.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.173, 93.233, 93.242, 93.350, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.866, 93.867.
• This funding opportunity was created on 2020-06-02.
• Applicants must submit their applications by 2020-10-02. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA HL 21 003

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