Thursday, July 24, 2014

$5 Million Sliced from California's Ambitious Alpha Stem Cell Clinic Program

Directors of the California stem cell agency today cut $5 million from their $70 million plan to create a series of Alpha stem cell clinics aimed at making the Golden State the leading location in the world for stem cell therapies.

On a 6-1-1 vote, the directors trimmed the effort, much touted by former agency President Alan Trounson. Eliminated was a data/information center whose tasks would have included marketing and patient education. The center also would have worked on strategies to persuade the federal government and insurance companies to pay for what are expected to be enormously expensive treatments.

The board has 29 members. However, only eight were allowed to vote because of conflicts of interest among the others. 

The cut by the board of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, came after its new president, Randy Mills, recommended scaling back the effort. He told the board the plan was not “clearly justified.”

He said in a memo,
“The proposal as written is too broad and overly complex to be successful. In a word, it lacks focus.”
Mills proposed that a refined RFA be reissued with $10 million in funding, which the board approved. It was the first time that the board had retroactively revised a concept plan and directed that an RFA be reissued.  

The Alpha clinic concept first surfaced publicly in 2011. Trounson and two other CIRM executives promoted the plan in a scientific journal financed by the stem cell agency. (See here and here for more.)

Trounson wrote that the scientific community owes it to persons suffering from diseases “to rapidly implement the best and safest practices for cell therapy clinical trials and move toward fast-tracking in therapies where safety and efficacy has been proven.” Nature Medicine said it would be the first-ever “clinical trials network focused around a broad therapeutic platform.”

Eight institutions have applied for the main portion of the award, which is designed to make California a one-stop shopping center for stem cell therapies. The hope is that patients will be attracted from throughout the world. Up to five awards are scheduled to be made for those clinics.

A separate RFA deals with the data center. Five institutions have applied in that RFA, including some also involved in the main portion.  The agency has already received all of the applications in both categories. Based on testimony today, it appears that UC San Diego, the City of Hope and Stanford have all submitted applications in the data center round. 

Although the applicants have not been identified by the agency, virtually all are likely to be represented by persons sitting on the CIRM governing board because of the nature of the concept plan and the RFA.

Review of the applications is scheduled for this September but was originally scheduled for June. In one of his first public actions, Mills delayed the review. The agency said it needed more time to secure knowledgeable reviewers, who must come from out-of-state.

Reduction of the size of the proposal will free cash for other research efforts. Directors are feeling increasingly pressed by financial issues. The agency is scheduled to run out of cash for new awards in less than three years. It is looking into some sort of public/private combination of financing that will allow it to continue in the same fashion beyond 2017.

The CIRM board approved the original Alpha concept in July 2013. At the time, the plan was hailed by the directors, who spent little time discussing the data center that was revised today.

Earlier items on the California Stem Cell Report incorrectly indicated that the effective reduction proposed totaled $15 million instead $5 million.

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