Limited Competition: Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UH3 Clinical Trial Optional)

Background
The Regenerative Medicine Innovation Project (RMIP) is a funding opportunity issued by the National Institutes of Health (NIH), specifically through the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Eye Institute (NEI), and National Heart, Lung, and Blood Institute (NHLBI). This initiative aims to support investigator-initiated clinical research studies that advance the field of regenerative medicine using adult stem cells.

The funding opportunity is part of fulfilling a statutory provision set forth in the 21st Century Cures Act, which authorized $30 million for clinical research in regenerative medicine from fiscal years 2017 through 2020.

Grant Details
The grant supports renewal cooperative agreement applications for follow-on studies to clinical trials previously funded under the RMIP. Projects should focus on innovative, safe, and effective regenerative medicine therapies. Key tasks include:
1. Continuation of trial-related activities that were incomplete in the original award.
2. Additional characterization of patients enrolled in prior trials.
3. Further analysis of samples or data collected from previous trials.
4. Follow-up for longer-term outcomes.
5. Any subsequent analysis that adds value to the original study.

The NIH encourages projects that address challenges in clinical development, improve product quality evaluation, utilize existing clinical research infrastructure, and enhance understanding of regulatory science issues.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local/state governments, tribal governments, and other entities as specified in the NOFO. Applicants must have previously received funding under specific NIH announcements related to RMIP to be eligible for this renewal opportunity.

Period of Performance
The maximum project period is up to 2 years with specific milestones to be reported annually.

Grant Value
NIH intends to commit total funds of up to $3,500,000 across this and a companion NOFO and anticipates issuing up to 5 awards. The Federal share must not exceed $400,000 in direct costs per year with a required matching contribution of at least 1:1 from non-Federal sources.

Place of Performance
The geographic location(s) for performance are expected to align with the applicant's institution.