Regenerative Medicine Innovation Projects (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required) | RFA HL 18 031

Opportunity Information: Apply for RFA HL 18 031

The Regenerative Medicine Innovation Projects (RMIP) Investigator-Initiated Clinical Trials funding opportunity (RFA-HL-18-031) is an NIH-led cooperative agreement designed to push adult stem cell-based regenerative medicine into well-run human clinical trials. NIH, working in coordination with the U.S. Food and Drug Administration (FDA), is looking for Phase I or later clinical trials that directly address major, widely recognized bottlenecks in developing regenerative medicine therapies that are both safe and effective. In practical terms, the program is not aimed at basic discovery work; it is aimed at getting credible, clinically ready regenerative medicine products into human testing and producing results that meaningfully move the field forward.

A central theme of this announcement is “readiness.” Proposed trials are expected to be built on a regenerative medicine product that is already sufficiently developed and supported by appropriate preclinical and product development work. Applications need to make a strong case that the therapy and the trial are scientifically justified, and that the team has a realistic operational plan to execute the study. The NIH is emphasizing innovation, but not in the sense of early-stage exploration; instead, innovation is expected to show up as concrete solutions to common translation problems in regenerative medicine, such as product characterization, potency and consistency, manufacturing and scale-up issues, delivery approaches, safety monitoring, and other factors that historically make regenerative medicine trials difficult to execute and interpret.

The award uses a two-phase, milestone-driven UG3/UH3 structure under a cooperative agreement mechanism. That means funding is split into an initial UG3 phase meant to support final preparatory work needed to launch the trial, followed by a UH3 phase that supports the actual execution of the clinical trial, but only if the project meets predefined milestones. Because it is a cooperative agreement, NIH staff are expected to be substantially involved compared with a typical grant, with active oversight and collaboration around progress, milestones, and overall conduct. The milestone-based design is meant to ensure that only projects that demonstrate true operational and regulatory readiness move into the later, more resource-intensive stage.

Applications are expected to include both scientific and operational detail, reflecting the realities of clinical trial implementation. The FOA calls for comprehensive plans covering trial conduct and oversight, project management, recruitment and retention strategies, performance milestones, and how the study will maintain quality and integrity throughout execution. It also places clear emphasis on transparency and responsible stewardship of results through data sharing and dissemination plans, signaling that the program values not only running the trial, but also ensuring that the findings (positive, negative, or inconclusive) are communicated in ways that benefit the broader research and clinical community.

Regulatory preparedness is treated as a gating requirement. Before an award is made, successful applicants must have, when applicable, FDA authorization or approval for an Investigational New Drug (IND) application or an Investigational New Device Exemption (IDE) so the investigational product can legally be administered to humans. This requirement underscores that the FOA is positioned at the point where a product is genuinely ready to enter clinical testing, rather than still navigating foundational regulatory or manufacturing uncertainties.

The trials supported under this program must align with the mission of at least one participating NIH Institute or Center and must meet the NIH definition of a clinical trial (as referenced in NOT-OD-15-015). Because regenerative medicine clinical trials can be unusually complex, the FOA strongly encourages applicants to contact the appropriate NIH scientific/research program staff before submitting. The intent is to help applicants ensure fit with the program’s goals, confirm institute/center relevance, and avoid preventable issues in study design, regulatory approach, or milestone structure.

Eligibility is broad across U.S.-based organizations and governmental units, including state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The opportunity also explicitly includes a range of community- and mission-focused institution types such as HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISI institutions, as well as faith-based or community-based organizations and eligible federal agencies. At the same time, it draws firm boundaries around foreign involvement: non-U.S. entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them) are not allowed.

From the published opportunity details, the sponsoring agency is the National Institutes of Health, the instrument is a cooperative agreement, the original closing date was October 19, 2018, and the listed award ceiling is $405,000. The opportunity is categorized under health-related funding activity areas and is associated with multiple CFDA numbers, reflecting participation across several NIH components.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Regenerative Medicine Innovation Projects (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, 93.856, 93.866, 93.867.
• This funding opportunity was created on 2018-08-01.
• Applicants must submit their applications by 2018-10-19. (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 $405,000.00 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.

Apply for RFA HL 18 031

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