CIRM Awards $25 Million for FDA’s First Embryonic Stem Cell Clinical Trial

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‚Äôs 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

CIRM was created by Proposition 71 in 2004, in response to President George W. Bush’s 2001 policy of limiting stem cell research to existing cell lines.

You can read more about the clinical trial at the L.A. Times. You can read and watch videos about the Phase I trial at Geron’s web site.

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.

Dr. Loring also cited a report of a man suffering from a spinal cord injury who has regained some feeling in his legs after receiving a transplant of this type of embryonic stem cell.

Dr. Jeanne Loring on the significance and potential of the stem cell trial :http://ww2.kqed.org/news/wp-content/uploads/sites/10/2011/05/stemcells1.mp3|titles=stemcells1

Author

Jon Brooks

Jon Brooks writes mostly on film for KQED Arts. He is also an online editor and writer for KQED's daily news blog, News Fix. Jon is a playwright whose work has been produced in San Francisco, New York, Italy, and around the U.S.

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