Limited Competition: Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Studies (U01 Clinical Trial Not Allowed)
ID: 359001Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    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.

    Point(s) of Contact
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    Title
    Posted
    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.
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