Opportunity Information: Apply for RFA HL 20 030
The Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3, Clinical Trial Required) opportunity is a National Institutes of Health (NIH) cooperative agreement funding program, coordinated with the U.S. Food and Drug Administration (FDA), aimed at moving promising adult stem cell-based regenerative medicine interventions into well-designed human clinical trials. It is part of NIH's implementation of a statutory directive in the 21st Century Cures Act and is framed as a practical, development-focused mechanism to address common barriers that slow or derail regenerative medicine therapies from reaching patients safely and effectively.
At its core, this FOA is looking for clinical trial proposals (Phase I and later) that are genuinely ready to enter human testing and that tackle widely recognized scientific, technical, manufacturing, and operational challenges in regenerative medicine. The emphasis is not on early exploratory laboratory work; it is on interventions that have already gone through appropriate product development and preclinical evaluation and can justify, with evidence, why the next step should be a clinical trial. Applications are expected to present a clear scientific rationale, a credible risk-benefit case for first-in-human or subsequent testing, and a complete operational plan that demonstrates the team can actually run the trial to high standards.
The funding structure is bi-phasic and milestone-driven, using the UG3/UH3 model. In practice, this means the project is planned in two linked stages with specific go/no-go criteria. The first stage (UG3) generally supports final trial start-up activities needed to reach a state of true readiness, such as finalizing key documents and procedures, aligning clinical sites, locking the protocol and statistical plan, completing manufacturing and quality steps, and positioning the study for regulatory authorization. The second stage (UH3) supports execution of the clinical trial itself. Progression from the UG3 phase to the UH3 phase depends on meeting predefined milestones, reflecting the program's intent to fund projects that can demonstrate momentum, accountability, and feasibility rather than open-ended development timelines.
Because the award is a cooperative agreement, NIH staff are expected to have substantial programmatic involvement compared with a standard grant. Applicants should anticipate close interaction with NIH (and coordination with FDA expectations where relevant), and they should build strong project management practices into the application. The FOA explicitly expects applicants to describe how they will manage the project, oversee sites and vendors, monitor progress, and keep the trial on schedule. Plans for participant recruitment and retention are also a major requirement, along with clear performance milestones, robust trial conduct procedures, and an approach for disseminating results in a responsible and transparent way.
A central compliance point is that, before an award is made and where applicable, the successful applicant must have authorization to administer the product to humans through an FDA Investigational New Drug (IND) application or an Investigational Device Exemption (IDE). In other words, if the proposed intervention requires FDA regulatory clearance to proceed in humans, that clearance cannot be an afterthought; it is treated as a gating requirement tied to award readiness. This reinforces the program's focus on therapies that are truly prepared for clinical translation, including manufacturing controls, quality systems, and documentation consistent with clinical-grade use.
The FOA also signals a broader field-building intent: projects proposing adult stem cells as the clinical intervention will be asked to provide representative samples of the source stem cell material and the clinical-grade stem cell-derived product for in-depth independent evaluation. This requirement reflects NIH's interest in strengthening confidence in regenerative medicine products by enabling deeper characterization, reproducibility checks, and comparability assessments that can help the wider community understand product attributes linked to safety and efficacy.
In terms of fit, proposed trials must align with the research 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). The eligible applicant pool is broad and includes many types of domestic organizations such as state, county, and local governments; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit entities (other than small businesses); small businesses; tribal governments and tribal organizations; and other entities as described in the FOA's eligibility language. The funding is listed under multiple CFDA numbers spanning health-related NIH programs, and the opportunity was originally posted by the U.S. Department of Health and Human Services, NIH, with an estimated five awards anticipated at the time of posting. The award ceiling is listed as zero, which typically indicates that applicants must follow FOA-specific budget guidance rather than relying on a single published cap.
Overall, this RMIP UG3/UH3 opportunity is best understood as a translational clinical trial launch-and-execute mechanism for adult stem cell regenerative medicine products that have already cleared key development hurdles. Competitive applications are expected to look like mature clinical development packages: strong preclinical justification, trial-ready manufacturing and quality approaches, realistic operational and recruitment plans, explicit milestones, regulatory readiness (IND/IDE when needed), and a clear plan to generate and share clinically meaningful evidence while meeting NIH and FDA expectations for safety, oversight, and transparency.Apply for RFA HL 20 030
- The Department of Health and Human Services, 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, 93.856, 93.866, 93.867.
- This funding opportunity was created on Aug 14, 2019.
- Applicants must submit their applications by Oct 18, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 5 candidate(s).
- 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 (see text field entitled Additional Information on Eligibility for clarification).
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