California's stem cell research agency has made its first award for a clinical trial. The recipient of the $25 million award is Geron Corp., the biotechnology company in Menlo Park, California, that is already testing cells derived from human embryonic stem cells (hESCs) to treat spinal cord injury.
Yesterday the governing board of the California Institute for Regenerative Medicine (CIRM) approved the Geron funding, which is actually a loan. Board Chair Robert Klein called the award "a landmark step for CIRM." Geron's phase I trial is the world's first approved trial (in 2009) for an hESC-derived therapy. (The Food and Drug Administration approved a second trial for an eye disease in November 2010). It has been in the news lately because its first patient, a young man in Georgia who was partially paralyzed in a car accident, has spoken to the press about his treatment.
CIRM has funded clinical studies before, including a $20 million loan to Novocell Inc., now known as Viacyte, in San Diego, but the awards were for pre-clinical work. The Geron loan is matched by company funds and will be repaid contingent on whether the treatment is commercially successful, according to Geron's press release.
An outside review last year urged CIRM to reach out more to industry. One of the agency's sometime critics, John Simpson of the advocacy group Consumer Watchdog in Santa Monica, California, was quoted in the Los Angeles Times praising the Geron loan as appropriate and well-vetted.
The board also approved $37.7 million for 27 basic biology grants as well as a plan to create a repository of induced pluripotent stem cells cells, which are derived from adult cells. The agency is collaborating on the project with the National Institute of Neurological Disorders and Stroke (for more, see this recent Nature story).