RFA-HL-23-017: Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)
Closed
This grant is closed. Who won this program's grants before is below, and similar open grants are at the end of the page. It is in our archive of National Institutes of Health notices from 2022.
National Institutes of Health offered grants of up to $345,000 to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. Applications closed on October 6, 2022.
From the official notice on Grants.gov, last changed July 8, 2022. Checked November 7, 2026.
- Award ceiling$345,000
- Cost sharingNot required
- Funding typeCooperative Agreement
About this NIH notice
- Activity codeUG3 / UH3
- Clinical trialsRequired
- Funded byNIDDK, NIAMS
- Median yearly award$393,980
- Typical project length3 years
- UG3, Exploratory/Developmental Phase I Cooperative Agreement. The first phase of a phased cooperative agreement. Moving on to the UH3 phase depends on meeting agreed milestones. Other open UG3 notices.
- UH3, Exploratory/Developmental Cooperative Agreement Phase II. The second phase of a phased cooperative agreement, usually following a UG3 or UH2 phase. Other open UH3 notices.
Projects funded under RFA-HL-23-017 were run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK, 2 projects) and National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS, 1 project). Contact the program officer at the institute that fits your project before you apply; the notice lists them.
Application due dates, page limits and budget limits are set in the notice. Read RFA-HL-23-017 in the NIH Guide.
Other notices with this title
| Notice | Posted | Deadline | Status |
|---|---|---|---|
| RFA-HL-22-014 | July 13, 2021 | Closed October 8, 2021 | Closed |
Key dates
| Posted | July 7, 2022 |
|---|---|
| Deadline | October 6, 2022 |
| Archived by Grants.gov | November 11, 2022 |
Who can apply
This opportunity was open to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.
All 15 applicant types the notice lists
- 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)
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Is this a realistic fit?
- Projects NIH funded under this notice had a median yearly award of $393,980; it allows up to $345,000 per award.
- Most of the money in the 11 programs behind this notice (72% over five years) went to colleges and universities.
- No cost sharing or match is required.
What the grant funds
The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seek highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely-recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials. This FOA seeks Phase I and beyond clinical trial applications that present a strong scientific rationale for the proposed clinical trial and a comprehensive scientific and operational plan. Trials must be relevant to the research mission of one or more participating NIH Institutes and Centers and meet the NIH definition of a clinical trial (see NOT-OD-15-015). Applications will be required to include plans for project management, participant recruitment and retention, performance milestones, conduct of the trial, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) authorization or Investigational New Device Exemption (IDE) approval to administer the product to humans.
Funded under RFA-HL-23-017 so far
NIH funded 3 projects under RFA-HL-23-017 in fiscal 2023 to 2026, at 2 institutions. The median yearly award was $393,980.
| Project | Institution | Fiscal year | Award |
|---|---|---|---|
| Safety and Efficacy of Mesenchymal Stem Cells in the Treatment of Chronic Pancreatitis and Its Associated Pain | Medical University of South Carolina | 2026 | $393,980 |
| Study of the Safety, Tolerability, and Efficacy of an iPS Cell-based Therapy for Recessive Dystrophic Epidermolysis Bullosa Delivered with a Spray on Skin Device | University of Colorado Denver | 2023 | $538,200 |
| Safety and Efficacy of Mesenchymal Stem Cells in the Treatment of Chronic Pancreatitis and Its Associated Pain | Medical University of South Carolina | 2023 | $327,555 |
Who has won Allergy and Infectious Diseases Research grants before
From fiscal 2021 to 2025, Allergy and Infectious Diseases Research (93.855) awarded $22 billion across 13,282 grant awards, an average of $1.6 million per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| Fred Hutchinson Cancer Center | Washington | 85 | $938 million |
| Duke University | North Carolina | 230 | $781 million |
| University of California, Los Angeles | California | 138 | $745 million |
| The Johns Hopkins University | Maryland | 321 | $668 million |
| Emory University | Georgia | 282 | $650 million |
Who has won Aging Research grants before
From fiscal 2021 to 2025, Aging Research (93.866) awarded $19 billion across 11,026 grant awards, an average of $1.7 million per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| The Regents of the University of California, San Francisco | California | 337 | $575 million |
| The Trustees of Columbia University in the City of New York | New York | 242 | $574 million |
| University of Southern California | California | 203 | $572 million |
| The Washington University | Missouri | 210 | $556 million |
| Regents of the University of Michigan | Michigan | 232 | $538 million |
Who has won Cardiovascular Diseases Research grants before
From fiscal 2021 to 2025, Cardiovascular Diseases Research (93.837) awarded $15 billion across 11,798 grant awards, an average of $1.2 million per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| The Trustees of the University of Pennsylvania | Pennsylvania | 313 | $380 million |
| Brigham & Womens Hospital Inc | Massachusetts | 274 | $374 million |
| Regents of the University of Michigan | Michigan | 277 | $355 million |
| The Trustees of Columbia University in the City of New York | New York | 207 | $335 million |
| University of Pittsburgh - of the Commonwealth System of Higher Education | Pennsylvania | 295 | $320 million |
Other programs behind this notice
- Diabetes, Digestive, and Kidney Diseases Extramural Research
- Extramural Research Programs in the Neurosciences and Neurological Disorders
- Vision Research
- National Center for Advancing Translational Sciences
- Arthritis, Musculoskeletal and Skin Diseases Research
- Oral Diseases and Disorders Research
- Lung Diseases Research
- Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
Applying now
This notice no longer takes applications. Agencies often post the same opportunity again under a new number, so check the program's notices on Grants.gov and the similar open grants below.
The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.
Questions people ask
Is RFA-HL-23-017 still open?
No. It closed on October 6, 2022.
Who can apply for Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)?
National Institutes of Health accepted applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. The notice adds further conditions, so read its eligibility section.
What is the deadline for Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)?
Closed October 6, 2022. Applications are no longer accepted; the program's newer notices are on this page when there are any.
How much funding is available?
Awards of up to $345,000 each.
Who has been funded under RFA-HL-23-017?
NIH RePORTER lists 3 projects funded under RFA-HL-23-017 in fiscal 2023 to 2026, at 2 institutions. The most were at Medical University of South Carolina, University of Colorado Denver.
Who has won Oral Diseases and Disorders Research grants before?
The largest recipients over five fiscal years were Regents of the University of Michigan, The Regents of the University of California, San Francisco, University of Southern California. The program made 2,263 awards worth $1.9 billion in that time.
Similar open grants
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- NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (UG3/UH3 Clinical Trial Optional)
- Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) for Novel therapeutic Agents for the Spectrum of Alzheimer's Disease (AD) and AD-related Dementias (ADRD) (UG3/UH3 Clinical Trial Required)
- Cellular Senescence Network (SenNet): SenNet Technology Projects (SenTecs) (UG3/UH3 Clinical Trial Not Allowed)
- Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)
- NIAMS Clinical Trial Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)