The California Institute of Research Medicine (CIRM), headquartered in San Francisco, announced today that it had:
...approved a $25 million award to support the first FDA-approved clinical trial based on cells derived from human embryonic stem cells. The award to Menlo Park-based Geron, Corp, will support the company’s on-going early phase trial for people with spinal cord injury. This is the first time the agency, which was created by the passage of proposition 71 in 2004, has funded a human clinical trial testing a stem cell-derived therapy. Full press release
KQED's Peter Jon Shuler talked about today's announcement with Dr. Jeanne Loring, director of the Center for Regenerative Medicine at The Scripps Research Institute in La Jolla, California. She said the only outcome that's important in a Phase I trial is to show that the procedure is safe; a demonstration of efficacy is not required to move to Phase II. The second phase would test for efficacy in a small group. If that proved successful, then Phase III would involve a larger and greater variety of patients.
There is no precedent for this type of therapy, she said, calling the process "painstaking" and estimating that it would take five years before even a Phase III trial would be implemented. But, she said, anyone planning a trial for therapies that address other types of disease will be able to learn from the Geron trial.