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

Background
The Regenerative Medicine Innovation Project (RMIP) is a funding initiative by the National Institutes of Health (NIH), specifically through its participating Institutes and Centers, including the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Eye Institute (NEI), and National Heart, Lung, and Blood Institute (NHLBI).

This funding opportunity aims to support renewal cooperative agreement applications for investigator-initiated studies that advance the field of regenerative medicine using adult stem cells. The initiative is part of fulfilling a statutory provision set forth in the 21st Century Cures Act, which authorized funding to enhance human health through innovative research in regenerative medicine.

Grant Details
The grant focuses on investigator-initiated preclinical research studies aimed at developing safe and effective regenerative medicine therapies using adult stem cells. Applications should continue to address the same therapeutic solutions as originally funded projects. Key areas of focus include:
1. Addressing critical issues in product development relevant for regulatory submissions.
2. Improving tools, methods, standards, or applied science for better evaluation of product characterization, manufacturing, potency, identity, quality, safety, effectiveness.
3. Conducting late-stage preclinical studies to generate evidence necessary for clinical development.
4. Sharing data generated from this award via the BioData Catalyst platform.
5. Ensuring compliance with a matching funds requirement where non-Federal contributions must equal Federal funds awarded.

Eligibility Requirements
Eligible applicants include higher education institutions (public and private), nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), local/state governments, tribal governments, and certain other entities. Only organizations currently funded under RFA-HL-18-030 or RFA-HL-23-019 are eligible to apply.

Period of Performance
The maximum project period is up to 2 years.

Grant Value
NIH intends to commit total funds of up to $3,500,000 across this funding opportunity and its companion NOFO. The Federal share must not exceed $400,000 in direct costs per year with a required 1:1 match from non-Federal sources.