CLIN 2: Funding Opportunity for Clinical Trial Stage Projects Grant

The California Institute for Regenerative Medicine (CIRM) offers funding opportunities for clinical trials focused on regenerative medicine therapies, including stem cell and genetic therapies. This initiative aims to accelerate the development of innovative treatments for unmet medical needs, providing up to $15 million for clinical studies. CIRM emphasizes partnership and resource support to ensure project success, addressing the critical stages of clinical trial development within a 48-month project period.

Objective
With this initiative, we intend to speed up support for clinical stage candidate stem cell treatments that demonstrate scientific excellence. Under this initiative, we will provide funding for eligible projects that are completing late stage preclinical development through any stage of clinical trial activity.
CLIN 2: Funding Opportunity for Clinical Trial Stage Projects
The objective of this funding opportunity is to support completion of a clinical trial for a regenerative medicine-based therapy (stem cell-based or genetic therapy) that addresses an unmet medical need.
Under this program, CIRM will act not only as a funding agency, but will also devote significant internal resources and leverage its external team of world-class subject matter experts to actively advance the project. The result of a successful application will be the formation of a true partnership that both accelerates the program and gives it the greatest opportunity for success.
The proposed Project Period must not exceed 48 months from the award start date, approximately 45 days after the date of ICOC approval. During the Project Period, CIRM funds shall only be used for allowable project costs and activities.
Total CIRM-Funded Project Costs for a CLIN2 project are limited to:
For first in-human clinical trial studies with the therapeutic candidate (or feasibility studies if the product is a medical device) in a specific disease indication and using a given route of administration$12,000,000 per award to a non-profit awardee; and$8,000,000 per award to a for-profit awardeeFor succeeding clinical trial studies conducted after a first in-human trial with the therapeutic candidate in a specific disease indication and using a given route of administration$15,000,000 per award for either a non-profit or for-profit awardeeThe amount of total project costs requested must be adequately justified and is subject to adjustments prior to issuance of an award based upon assessments of the Grants Working Group (GWG), the CIRM team, or by the Application Review Subcommittee of CIRM’s Governing Board.