Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)
Agency: National Institutes of Health
Assistance Listings
- 93.838 -- Lung Diseases Research
- 93.839 -- Blood Diseases and Resources Research
- 93.856 -- Microbiology and Infectious Diseases Research
- 93.837 -- Cardiovascular Diseases Research
- 93.840 -- Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
- 93.847 -- Diabetes, Digestive, and Kidney Diseases Extramural Research
- 93.867 -- Vision Research
- 93.853 -- Extramural Research Programs in the Neurosciences and Neurological Disorders
- 93.242 -- Mental Health Research Grants
- 93.846 -- Arthritis, Musculoskeletal and Skin Diseases Research
- 93.866 -- Aging Research
- 93.855 -- Allergy and Infectious Diseases Research
- 93.233 -- National Center on Sleep Disorders Research
- 93.121 -- Oral Diseases and Disorders Research
- 93.350 -- National Center for Advancing Translational Sciences
- 93.173 -- Research Related to Deafness and Communication Disorders
Archived opportunityLast Updated: May 13, 2026
View version history on Grants.gov
Description
The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks 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 are expected 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. Successful applicants proposing the use of adult stem cells as a clinical intervention will be asked to make available representative samples of the source stem cell and clinical-grade stem cell-derived product for in-depth and independ
Eligibility
Eligible applicants
Miscellaneous
- Other
Government
- City or township governments
- Public and Indian housing authorities
- County governments
- Special district governments
- Federally recognized Native American tribal governments
- State governments
Business
- For-profit organizations other than small businesses
- Small businesses
Nonprofit
- Nonprofits non-higher education with 501(c)(3)
- Nonprofits non-higher education without 501(c)(3)
- Other Native American tribal organizations
Education
- Independent school districts
- Private institutions of higher education
- Public and state institutions of higher education
Additional information
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.
Grantor contact information
Description
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster
Documents
No documents are currently available.
Link to additional information
http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-20-030.html
Archived: November 23, 2019
Award
$3,118,000
Program Funding
5
Expected awards
$--
Award Minimum
$--
Award Maximum
Funding opportunity number:
RFA-HL-20-030
Cost sharing or matching requirement:
No
Funding instrument type:
Cooperative agreement
Opportunity Category:
Discretionary
Opportunity Category Explanation:
--
Category of Funding Activity:
Food and nutrition
Health
Category Explanation:
--
History
Version:
1
Posted date:
August 14, 2019
Archive date:
November 23, 2019
