California Stem Cell Agency Shifts Focus to Clinical Treatments

1/31/13Follow @tanseyverse

California’s stem cell research funding agency has been shifting gears, and California entrepreneurs stand to benefit. The California Institute for Regenerative Medicine (CIRM) plans to spend hundreds of millions of dollars over the next four years to support early stage clinical trials and other work toward regulatory approval of commercial therapies.

What’s more, industry advisors may soon have a bit more influence over CIRM’s decisions.

The grantmaking institution based in San Francisco, which had devoted the bulk of its earliest awards to basic research and stem cell lab construction at California research centers, is now focused on advancing stem cell science into the clinic and forming partnerships with companies.

However, CIRM’s era as a major funding source for California businesses may not continue for many years. The $3 billion stream of state bond funding that was given CIRM through a voter initiative in 2004 will be used up by 2017. To create a second life for the institute, its leadership has begun considering a range of options to pump in new capital—from a venture philanthropy fund to a second ballot initiative. The first opportunity for a statewide vote is the general election in November 2014.

Nothing has yet been decided, says Jonathan Thomas, chair of CIRM’s 29-member governing board, the Independent Citizens’ Oversight Committee. But the agency’s leaders have taken steps recently to showcase its accomplishments and shore up its public image as preparation for an appeal to private donors or California taxpayers.

“It’s important to us to be able to convey the progress,’’ Thomas says.

One CIRM-funded project is expected to begin mid-stage clinical testing this year. The small Beverly Hills biotechnology company Capricor will receive up to $19.7 million to test heart-derived stem cells as a treatment for the deterioration of coronary muscles after heart attacks. As many as five trials may have begun by the end of 2014 with CIRM support, says Dr. Ellen Feigal, CIRM’s vice president of research and development.

neonatal mouse heart cells

Fluorescent micrograph of neonatal mouse heart cells, taken as part of a CIRM-funded project investigating stem approaches to growing heart tissue in the lab of Kara McCloskey at the University of California, Merced.

But the agency’s progress, in the view of CIRM leaders, has been overshadowed by a persistent outcry over its governance structure, which critics say is hobbled by inherent conflicts of interest. On CIRM’s governing board, 13 seats are guaranteed for representatives of five University of California campuses and eight other California research centers—each qualified to benefit substantially from CIRM’s grants. That leadership structure was specified by the ballot initiative that created CIRM, Proposition 71.

CIRM leaders have repeatedly insisted that the agency’s grantmaking decisions are impartial. But an Institute of Medicine panel, in a December report commissioned by CIRM, strongly echoed the conflict of interest concerns. In response, the stem cell agency’s board endorsed a package of proposals from Thomas at its Jan. 23 meeting. Under one provision, the 13 members viewed as having built-in conflicts of interest would abstain from voting on all grant decisions—at least for a trial period. The CIRM board will vote on the final language in March.

Board vice chair Duane Roth said the Institute of Medicine review is the third outside report warning CIRM that perceived conflicts of interest were undermining its public support.

“If we lose our credibility with the voters and the taxpayers, there will not be any more money,’’ Roth said at the Jan. 23 meeting.

Despite its critiques, the Institute of Medicine review panel credited CIRM with progress on the sweeping goals laid out for it in Proposition 71. Supporters of the initiative had promoted it to voters with a range of enticements: CIRM was to fund basic research in a promising scientific field almost at the dawn of its development, position California as a leader in the sector, and also make progress toward treatments so rapidly that … Next Page »

Bernadette Tansey is a freelance journalist based in Berkeley, CA. Follow @tanseyverse

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