Regenerative Medicine Innovation Projects (RMIP) Clinical Trial Planning Grant (R34 - Clinical Trials Not Allowed)

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The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA) support the Regenerative Medicine Innovation Project (RMIP), which aims to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. Before a research team undertakes a clinical trial, it is critical to have clear delineation and documentation of the trials rationale, design, analytic techniques, protocols, and procedures in a Manual of Procedures (MOP). Additionally, there are other elements essential to the launching of a trial, such as obtaining regulatory authorizations or approvals and establishing agreements with requisite partners including cell manufacturing and production facilities, assay or cell analysis centers, and data coordinating centers. These activities are often costly and time-consuming, and they may involve collection of preliminary data to assess feasibility. Applicants may use the RMIP Clinical Trial Planning Grant to support the preparation of a clinical trial MOP and procedures necessary for implementing a clinical trial to evaluate interventions (or new treatments) that explore and enable the evaluation of the safety and/or efficacy of RM interventions using adult stem cells that are not of embryonic or fetal origin. Due to the complex nature of requirements in this FOA (e.g., 1:1 matching funds, resource sharing), applicants are strongly encouraged to communicate with the appropriate NIH Scientific/Research Contact and review online Frequently Asked Questions (FAQs) prior to submitting an application. Staff will be able to advise applicants in determining if their research meets the requirements and objectives of this FOA.

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