Teams beginning clinical studies or completing early-stage trials within four years will be supported.
The California Institute for Regenerative Medicine (CIRM) approved the concept for up to $243 million in funding to move stem cell-based therapies into clinical trials. The CIRM Disease Team Awards II will support up to 12 awards worth up to $20 million each.
The funding round represents the second in a recurring round of funding intended to support multidisciplinary teams of researchers working toward filing a request to begin clinical trials or completing Phase I or II studies within four years. By funding teams rather than individual researchers, CIRM acknowledges the varied expertise required for translational and clinical research. The agency will actively encourage industry participation.
Applications will take place in two parts. A lead investigator must first apply for a Disease Team Planning Award of up to $110,000, which will fund approximately 35 grants to assemble teams, plan, and prepare their more elaborate Disease Team Award application. Only those teams that receive a planning award can submit an application for the full Disease Team Award. Recipients of the first round of Disease Team Awards will be able to request approval to expand their projects to include post-IND activities including clinical trials using unspent funds from the original grant.
Separately, CIRM’s board voted to fund an independent assessment by the Institute of Medicine of the National Academies of Science to promote public accountability and obtain an independent evaluation of the performance and standards of the stem cell agency. This study will be paid for out of donor funds contributed to the agency specifically to pay for studies and workshops. The report would have a goal of completion within 22 to 26 months, with recommendations for short-, medium-, and long-term actions to improve the performance of the agency.
The board also voted to support Assembly Bill 52, California Umbilical Cord Blood Collection Program, which requests that the University of California establish and administer the Umbilical Cord Blood Collection Program.