The National Eye Institute (NEI) supports regenerative medicine clinical trials. Before a research team undertakes a clinical trial, it is critical to have clear delineation and documentation of the trial’s 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. The Regenerative Medicine Clinical Trial Planning Grant may be used by applicants to support the preparation of a clinical trial MOP and procedures necessary for implementing a clinical trial to evaluate interventions (or new treatments) that restore vision in humans through regeneration of cells.
Deadlines:
- R34 Deadlines: Feb. 16, Jun. 16, Oct. 16
- AIDS Deadlines: Jan 7, May 7, Sep 7
PAR-22-135 Expiration Date New Date December 19, 2024 per issuance of NOT-EY-25-003. (Original Expiration Date: May 08, 2025 )
The NEI permits direct costs up to $150,000 per year plus applicable F&A for consortia.
The scope of the proposed project should determine the project period. The maximum period is two years.