The California Institute for Regenerative Medicine (CIRM) recently granted $230 million in Disease Team Research Awards to get stem cell-based therapies into the clinic within 4 years (
California Institute for Regenerative Medicine). Up to $20 million will go to each of 14 California-based interdisciplinary research groups, with the first funding checks to be sent out next month. The expectation is that within 4 years each group will submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for a phase I clinical trial. To receive the funding, the research teams are required to include basic scientists and clinicians from academia and industry, with the goal of getting test agents rapidly into clinical trials and addressing clinical issues early in the research process. CIRM's President, Alan Trounson, estimates that 75% of the projects funded will result in IND applications to the FDA within the 4 year funding period. “I am impressed with these teams—some have already had pre-application meetings with the FDA,” says Trounson. He emphasizes that all of the Disease Teams include researchers that have been through the IND application process.
The CIRM-funded projects propose to develop new stem cell therapies to treat 11 diseases including AIDS, diabetes, sickle-cell anemia, amyotrophic lateral sclerosis (ALS), ischemic heart disease, several different types of cancer, stroke,
macular degeneration, and the rare genetic skin disease dystrophic epidermolysis bullosa.
“We were open to all stem cell approaches and wanted to include as many diseases as possible, especially those with no cures…we wanted to see creative uses of stem cells and encouraged investigators to aim higher and bite off bigger chunks than in most grant applications,” says Bettina Steffen, Science Officer at CIRM. The review committees “considered any role of the stem cell as part of the actual therapeutic or even as part of a screening platform to identify drugs,” she adds.