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