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California agency set to vote on stem cell clinic plan

A laboratory worker lifts a frozen vial of human embryonic stem cells at the University of Michigan Center for Human Embryonic Stem Cell Research Laboratory in Ann Arbor, Mich. CIRM, California's stem cell agency, will vote this week on a plan to open five stem cell clinics to test treatments.
(Paul Sancya / Associated Press)
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The governing board of the California Institute for Regenerative Medicine, or CIRM, will vote Thursday on whether to move ahead with a five-year, $70-million plan to establish a network of stem cell clinics.

According to a proposal posted on CIRM’s website, the CIRM Alpha Stem Cell Clinics Network will be composed of up to five clinics in California, each affiliated with an established research institution and all designed to make it easier for researchers to conduct -- and for patients to find -- clinical trials of stem cell therapies.

“This fits in with the broader mission of CIRM extremely well. There’s the imperative to bring this research to clinical application and to therapies,” said CIRM special projects officer Natalie DeWitt.

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STEM CELLS: Los Angeles Times coverage

CIRM, founded in 2004 after California voters approved Proposition 71, initially distributed funds from its $3-billion coffers mostly for basic science -- including work with embryonic stem cells that the federal government under President George W. Bush declined to fund.

But as time has passed, CIRM’s focus has shifted toward funding projects that could produce cures for patients more quickly, such as efforts to use stem cells to treat brain tumors, heart disease and sickle cell anemia. The Alpha clinics could accelerate that drive toward therapies, DeWitt and CIRM medical officer Maria Millan said in an interview with The Times on Tuesday.

Clinics to conduct trials of stem cell therapies have different needs than clinics designed to deliver conventional therapies, DeWitt and Millan said. They need special facilities for handling the cells safely, as well as imaging equipment to track the cells once they’re delivered into a patient’s body. Some of this infrastructure already exists, but other parts of it still need to be perfected. Establishing clinics to house multiple trials might create the critical mass needed to get the infrastructure in place, they said.

“If there’s a way to make this a resource that isn’t just used by a single entity, that would move things forward,” said Millan. “It will also promote collaboration. One success will be success for the field.”

Additionally, they said, CIRM hopes that such collaboration would encourage stem cell companies to share information -- speeding their own work and also helping out policymakers and insurers who are trying to figure out how they’ll pay for stem cell therapies in the future. In addition to the clinics themselves, the CIRM proposal calls for creation of a Coordinating and Information Management Center, which would coordinate data from all of the sites.

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Part of the network’s mission would also be to get information to patients and their families, DeWitt said, which includes trying to discourage people from seeking out sham stem cell treatments. “One key activity of the CIMC will be to tell people what is proven and what should be avoided,” she said.

If CIRM’s governing board approves the plan Thursday, the agency will embark on a yearlong process to vet applications from research centers that want to host the clinics and choose sites. One requirement is that applicants explain how they’ll sustain the clinics financially over the long term, when CIRM may no longer be around. The agency’s bond funding is currently set to expire in 2017.

“The Alpha clinics are aimed at creation of a sturdy foundation for the stem cell industry in California, capitalizing on the burgeoning, international lure of stem cell treatments,” David Jensen of the California Stem Cell Report wrote last week. But he also noted that at least one critic thought the clinics could turn out to be “unneeded infrastructure,” “an irresponsible waste” and “a boondoggle for some medical schools.”

Thursday’s meeting of CIRM’s governing board will take place in Burlingame, Calif., and will be webcast (visit this webpage for further details).

You can click here to read a 2012 report on the Alpha Stem Cell Clinic concept written by CIRM President Alan Trounson, DeWitt and Ellen Feigal and published in the journal Stem Cells Translational Medicine.

Jensen’s California Stem Cell Report, which will track Thursday’s meeting, is here.

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