Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required) | RFA HL 23 017

Opportunity Information: Apply for RFA HL 23 017

The Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials opportunity (UG3/UH3; Clinical Trial Required) is a National Institutes of Health (NIH) cooperative agreement funding program run in coordination with the U.S. Food and Drug Administration (FDA). Its main purpose is to push forward the clinical development of regenerative medicine interventions that use adult stem cells, with a strong emphasis on advancing products that are ready to move into human testing and on addressing practical, well-known barriers that slow the field down. This program is part of NIH's implementation of a requirement established under the 21st Century Cures Act, and it is designed to support projects that can realistically help enable safe and effective regenerative therapies.

A defining feature of the program is its bi-phasic structure and milestone-driven design using the UG3/UH3 mechanism. In practice, this means projects are expected to begin with a planning and start-up phase (UG3) and then transition to an expanded implementation phase (UH3) only after meeting clearly defined performance milestones. Because this is a cooperative agreement rather than a standard grant, NIH will have substantial involvement in the project, including oversight tied to those milestones, coordination expectations, and a focus on whether the trial is progressing as proposed. Applicants are expected to build a detailed operational blueprint from the outset, with measurable objectives that demonstrate readiness to execute the study and a clear pathway for moving from one phase to the next.

The FOA is specifically seeking Phase I and later clinical trials (not just early exploratory work) that have a strong scientific justification and a comprehensive plan for trial execution. Projects should center on regenerative medicine products that have already completed appropriate product development and preclinical testing, with evidence that the intervention is sufficiently mature to advance into clinical evaluation. In other words, the program is not aimed at basic discovery; it is aimed at taking credible, well-prepared regenerative medicine candidates into the clinic and generating meaningful clinical evidence while also improving the general development playbook for this area of medicine.

Applications must meet the NIH definition of a clinical trial and align with the research mission of at least one participating NIH Institute or Center. The application is expected to include more than the scientific hypothesis and protocol; it must also provide a full operational and management approach. That includes project management structures, recruitment and retention strategies, detailed study conduct plans, performance milestones and timelines, and a strategy for dissemination of results. The emphasis on recruitment/retention and operational readiness reflects NIH's goal of funding trials that can actually enroll participants, maintain adherence, and deliver interpretable outcomes within a realistic timeframe.

Regulatory readiness is a major gatekeeping requirement. Before an award can be made, successful applicants must be positioned to obtain, and where applicable must obtain, an FDA Investigational New Drug (IND) authorization or an Investigational New Device Exemption (IDE) approval that allows the proposed product to be administered to humans. This highlights that the program expects applicants to have already done the foundational regulatory and manufacturing groundwork (or to be very close), rather than treating those steps as uncertain future tasks.

Eligibility is broad across U.S.-based organizations and governmental entities. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments and certain tribal organizations; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly calls out inclusion of organizations such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

At the same time, foreign involvement is tightly restricted. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed. The structure clearly signals that NIH intends this funding to support domestic clinical development and infrastructure without foreign subcomponents.

Administrative details from the listing include the Funding Opportunity Number RFA-HL-23-017, the funding instrument type (cooperative agreement), and the activity category focus on health-related research (with multiple CFDA numbers tied to NIH programs). The posted original closing date for the opportunity was October 6, 2022. The listing also shows an award ceiling of $345,000, though with NIH cooperative agreements the actual budget and project period structure typically depend on the FOA's full text and the approved scope, including the UG3/UH3 phase transition and milestone achievement.

• 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, 93.233, 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 2022-07-07.
• Applicants must submit their applications by 2022-10-06. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $345,000.00 in funding.
• 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.

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