OpportunityTitle: Regenerative Medicine Innovation Projects (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3  Clinical Trial Required)
AdditionalInformationOnEligibility: Other Eligible Applicants include the following:  Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 not allowed.
Description: The National Institutes of Health (NIH), participating NIH Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite exploratory/developmental phased award cooperative agreement (UG3/UH3) applications to support investigator-initiated clinical trials (Phase I or later phase) aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that use RM products with demonstrated readiness to be advanced into clinical trials through appropriate product development and pre-clinical studies. Trials for which this FOA applies 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). This FOA utilizes a bi-phasic, milestone-driven cooperative agreement mechanism of award. This FOA seeks applications that present a strong scientific rationale for the clinical trial and a comprehensive scientific and operational plan. It is anticipated that applications will consist of plans for project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, data sharing, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) application authorization or approval, respectively, to administer the product to humans. Due to the complex nature of conducting a clinical trial, applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application. Staff will be able to assist applicants in meeting the objectives of this FOA.
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