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.Apply for RFA HL 21 003
- 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.
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FAQs: Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3)
What is this funding opportunity?
This opportunity is an NIH cooperative agreement (UG3/UH3) under the Regenerative Medicine Innovation Project (RMIP) that supports investigator-initiated clinical trials aimed at moving adult stem cell-based regenerative medicine interventions into well-planned human clinical testing.
What is the main purpose of the RMIP UG3/UH3 program?
The purpose is to accelerate the development and clinical testing of safe and effective adult stem cell-based regenerative medicine therapies by funding trials that are scientifically strong, operationally realistic, and aligned with regulatory expectations.
How is this program connected to the 21st Century Cures Act?
The program is explicitly tied to the 21st Century Cures Act, which directed federal agencies to help accelerate the development of regenerative medicine therapies, and NIH is running RMIP in coordination with the U.S. Food and Drug Administration (FDA).
What does it mean that this is a cooperative agreement rather than a standard grant?
As a cooperative agreement, NIH program staff have a more active role than is typical for standard grants. NIH involvement is intended to help ensure projects remain aligned with program goals, timelines, and required deliverables, especially given the milestone-driven structure.
What is the UG3/UH3 structure?
The award is bi-phasic (two-stage). The UG3 phase supports start-up and readiness activities, and the UH3 phase supports expanded execution of the clinical trial after predefined milestones are successfully met.
Are milestones optional or negotiable?
No. The design is milestone-driven and emphasizes accountability. Milestones are intended to enforce readiness, operational capacity, and progress toward meaningful endpoints before a project can move from UG3 to UH3.
What kinds of interventions does this FOA focus on?
The FOA is specifically focused on regenerative medicine products that use adult stem cells, with emphasis on interventions that have already completed appropriate product development and preclinical evaluation.
Does the program support early-stage, exploratory concepts?
No. Applicants are expected to propose therapies that are truly ready to move into clinical trials, rather than early exploratory ideas.
What clinical trial phases are supported?
The FOA solicits Phase I and later-stage trials (Phase I and beyond).
Does the proposed study have to meet NIH's definition of a clinical trial?
Yes. The clinical trial must meet the NIH definition of a clinical trial, and the FOA references NOT-OD-15-015 for that definition.
Does the trial need to align with NIH Institute/Center missions?
Yes. The clinical trial must fall within the mission of at least one of the participating NIH Institutes or Centers.
What types of challenges or "bottlenecks" is NIH hoping to address through this program?
The program is interested in innovative projects that address well-recognized translational bottlenecks such as manufacturing consistency, potency and characterization, safety risks, delivery methods, and other barriers that commonly slow or derail regenerative medicine development.
What level of operational detail is expected in the application?
Applications are expected to include a detailed and credible operational plan describing study management, participant recruitment and retention, performance milestones, intervention administration, safety and outcome monitoring, data analysis, and dissemination of results.
What does "regulatory readiness" mean for this opportunity?
Regulatory readiness is a major requirement. Before an award can be made (when applicable), the applicant must secure FDA authorization to administer the product to humans through an IND (for biologic/drug products) or an IDE (for device-based interventions).
Is FDA authorization required before NIH makes an award?
Yes, when applicable. The FOA indicates that FDA authorization (IND or IDE, depending on the intervention) is required prior to award.
What does the FOA imply about Chemistry, Manufacturing, and Controls (CMC)?
The FOA signals that applicants are expected to have credible CMC plans and the documentation needed to satisfy FDA expectations for early human testing, along with appropriate clinical monitoring plans.
Are there any special expectations around product transparency or independent evaluation?
Yes. Successful applicants using adult stem cells as the clinical intervention will be asked to provide representative samples of the original source stem cells and the clinical-grade, stem cell-derived product for in-depth and independent evaluation.
Why does NIH want representative product samples?
The intent is to strengthen confidence in product quality, reproducibility, and safety across the regenerative medicine ecosystem by enabling independent assessment.
Who is eligible to apply?
Eligibility is broad among U.S.-based organizations, including state/county/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; nonprofits (501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); and small businesses.
Are institutions like HBCUs, HSIs, and Tribal colleges eligible?
Yes. The FOA highlights additional eligible applicants such as HBCUs, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs.
Are faith-based or community-based organizations eligible?
Yes. The FOA includes faith-based or community-based organizations among the eligible applicants.
Are federal agencies eligible to apply?
Yes. The FOA indicates that eligible federal agencies may apply.
Are non-U.S. (foreign) organizations eligible to apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply as applicant organizations.
Can a U.S. organization include a non-U.S. component?
No. Non-U.S. components of U.S. organizations are not eligible.
Are foreign components allowed under NIH policy definitions?
No. Foreign components (as defined in NIH policy) are not allowed for this FOA.
Where is the supported work expected to be conducted?
Based on the stated restrictions on foreign entities, non-U.S. components, and foreign components, the supported work is intended to be conducted entirely within eligible U.S. organizational structures and locations.
What is the funding opportunity identifier mentioned in the source information?
The source information identifies the opportunity as RFA-HL-21-003.
What is the listed closing date in the source information?
The original closing date listed is October 2, 2020.
Are multiple NIH Institutes and Centers involved?
Yes. The opportunity is associated with multiple CFDA numbers spanning NIH programs, reflecting participation across multiple NIH Institutes and Centers rather than a single disease area.
What is the overall theme of the opportunity?
This FOA is an execution-focused translational pathway for adult stem cell regenerative medicine products that are ready for clinical testing, emphasizing regulatory clearance, rigorous clinical trial operations, milestone-based progress, and credible sharing of clinical findings.
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