Cooperative AgreementPostedDiscretionary

Limited Competition: Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Studies (U01 Clinical Trial Not Allowed)

National Institutes of Health
RFA-AR-25-013
Application Deadline
Oct 21, 2025
Closed
Days Remaining
0
Deadline passed
Award Ceiling
Total Program Funding

Grant Opportunity Analysis

The National Institutes of Health (NIH) is offering a funding opportunity titled "Limited Competition: Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Studies (U01 Clinical Trial Not Allowed)" aimed at supporting preclinical research using adult stem cells. This initiative invites current recipients of prior RMIP grants to submit renewal applications that focus on late-stage preclinical studies, enhancing the development of safe and effective regenerative medicine therapies while addressing critical regulatory issues and promoting data sharing. The NIH plans to allocate up to $3.5 million in federal funds, with a requirement for successful applicants to match these funds with non-federal contributions on a 1:1 basis, as mandated by the 21st Century Cures Act. Interested applicants must adhere to specific guidelines and demonstrate significant collaboration with NIH staff, with applications due by October 21, 2025. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the opportunity's webpage at https://grants.nih.gov/grants/guide/rfa-files/RFA-AR-25-013.html.

Eligible Applicants

Others
Additional Eligibility Information

Other Eligible Applicants include the following: Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Indian/Native American Tribal Governments (Other than Federally Recognized); Regional Organizations; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 allowed.

Grant Documents

2 Files
RFA-AR-25-013-Full-Announcement.html
HTML0 KBJun 20, 2025
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RFA-AR-25-013.html
HTML126 KBJun 20, 2025
AI Summary
The National Institutes of Health (NIH) is releasing a funding opportunity aimed at supporting the Regenerative Medicine Innovation Project (RMIP) for preclinical research using adult stem cells. This opportunity, designated RFA-AR-25-013, invites current recipients of prior RMIP grants to submit renewal applications focusing on late-stage preclinical studies that enhance the development of safe and effective regenerative medicine therapies, addressing critical regulatory issues and promoting data sharing. The NIH aims to allocate up to $3.5 million from federal funds, requiring successful applicants to match these funds with non-federal contributions on a 1:1 basis, as stipulated by the 21st Century Cures Act. Applications are required to adhere to rigorous project plans demonstrating significance, innovation, and feasibility, and they must involve human-derived materials, ensuring no use of embryonic or fetal stem cells. Key project outcomes are expected to support the regulatory process for Investigational New Drug (IND) or Investigational Device Exemption (IDE) submissions. The application process emphasizes compliance with specific guidelines and necessitates significant collaboration with NIH staff. Overall, this funding initiative seeks to advance knowledge in regenerative medicine and its clinical applications while fostering robust partnerships within the research community.

Related Grant Opportunities

Project Timeline

postedOriginal Opportunity PostedJun 17, 2025
deadlineApplication DeadlineOct 21, 2025
expiryArchive DateNov 26, 2025

Funding Details

No cost sharing required

Agency & Classification

Agency
National Institutes of Health(HHS-NIH11)
Funding Category
Health
Funding Instrument
Cooperative Agreement

Grantor Contact

CFDA Numbers

93.867

Official Sources