California agency adopts $70M plan for stem cell clinical trial network

The governing board of the California Institute for Regenerative Medicine voted Thursday to adopt a $70-million plan to develop a network of clinics for conducting trials of experimental stem-cell therapies.

The vote authorizes CIRM to begin accepting applications from academic institutions interested in hosting clinics. Ultimately, the Alpha Stem Cell Clinics Network will include up to five clinics as well as a coordinating center to shoulder some of their load, such as enrolling patients and handling the paperwork involved in clinical trials.

The board approved the plan by a vote of 19 to 1, according to David Jensen, publisher of the California Stem Cell Report. The one dissenter was Joan Samuelson, founder of the Parkinson's Action Network, "who questioned whether the plan was premature and whether existing scientific research justified development of the clinics," Jensen reported.

The Alpha network reflects CIRM's recent focus on helping researchers convert stem-cell discoveries from the lab into useful treatments for patients with a range of conditions, including Parkinson's, Type 1 diabetes and spinal cord injuries.

Scientists value stem cells because they are capable of growing into a variety of cell types in the body. That means that -- under the right conditions -- they could be used to make cells that would replace the myelin that is lost in patients with multiple sclerosis, disrupting communication in the nervous system and causing symptoms like muscle spasms and and speaking problems. In principle, stem cells could also be coaxed to grow into a primitive liver that, when transplanted into a patient, would mature on its own.

"If we went 10 years and had no clinical treatments, it would be a failure," CIRM's director, Alan Trounson, explained in 2010. "We need to demonstrate that we are starting a whole new medical revolution."

The state agency was created by Proposition 71, the 2004 ballot measure that earmarked $3 billion for stem cell research. The initial motivation was to bankroll research on human embryonic stem cells after President George W. Bush set strict limits on the use of federal funds for such work.

That focus broadened after President Obama relaxed those limits. The development of induced pluripotent stem cells -- which behave very much like embryonic stem cells but are not made from embryos and therefore could qualify for federal funding -- also reduced the need for CIRM to fund basic research.

In its plan for establishing the Alpha network, CIRM officials appear to anticipate the day when the agency's $3 billion in funding runs out. (That could happen as soon as 2017, unless another ballot initiative brings more money or some other funding source materializes.) Institutions applying for one of the five slots will have to convince CIRM that they'll sustain their clinic "over the long term, when CIRM may no longer be around," my colleague Eryn Brown reported.

Another reason to create the clinical trial network is to make it easier for patients to find reliable information about stem cell research and therapies, CIRM officials said.

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California agency adopts $70M plan for stem cell clinical trial network