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Shift in Stem Cell Grant Policy

On Thursday, the California Institute for Regenerative Medicine is expected to approve a funding grant for a type of clinical trial that the agency has rarely made — a late-stage, Phase III clinical trial.

“It’s new,” said Kevin McCormack, the senior director of public communications and patient advocate outreach at CIRM.

“In the past, we’d put out a request for clinical trials and we’d typically get trials in the initial phases,” McCormack said. “We’ve changed the way we work, it’s more of an open call now. We’ve had one Phase III funded, and probably another one [Thursday].”

CIRM is the state’s stem cell agency, founded in 2004 when California voters approved Proposition 71, which set aside $3 billion to help stem cell researchers develop therapies for various conditions.

“Our mission is quite simple,” McCormack said. “To accelerate therapy for patients in need. The whole point about this is to get the best science as fast as we could.”

McCormack said the early-stage clinical trials typically ran about 22 months — but the Phase III trials likely go 120 days, a difference of a year and a half.

“If you can shave [18] months off getting a therapy to patients, that’s a lifetime,” McCormack said.

The late-stage clinical trial that’s expected to be approved Thursday would target glioblastoma, a type of brain tumor that afflicts about a thousand more people in California every year. The promise of this particular stem cell therapy would be increased survival rates, improved quality of life and potentially a cure for many of these patients.

And soon, McCormack said.

“We’ve tried to be more responsive to the companies’ and the researchers’ needs,” he said. “Patients will have access to some of these therapies much sooner.”  

McCormack said there has been one other Phase III clinical trial approved for CIRM grant funding, a trial for metastatic melanoma.

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