California’s stem cell agency voted yesterday to slice $5 million from the $70 million it approved last year toward opening a statewide network of stem cell clinics, with the new president and CEO saying that the program was unwieldy and needed to be refocused.
Last year, the California Institute for Regenerative Medicine (CIRM) agreed to spend the $70 million to create the Alpha Stem Cell Clinics Network. The network was conceived as consisting of five sites operating across California and functioning as a hub for stem cell clinical trials.
The governing board of CIRM acted at the urging of President C. Randal Mills, Ph.D. Dr. Mills took office earlier this year, succeeding Alan Trounson, Ph.D., who had championed the Alpha clinic program, declaring: “These clinics have the potential to revolutionize how we deliver stem cell therapies to patients.”
The $5 million reduction eliminated funding for the Coordinating and Information Management Center (CIMC) portion of the Alpha clinics’ concept plan. The center was conceived as carrying out a variety of functions that include clinical operations, data sharing, healthcare reimbursement modeling, and promotion of California as a destination for stem-cell “tourism” by patients seeking regenerative medicine therapies.
CIMC was envisioned as the hub of the Alpha Stem Cell Clinics Network, whose sites were supposed to share information and expertise “to enhance efficiencies and accelerate clinical trials for stem cell therapies, and delivery of approved therapies,” according to background materials furnished to the board.
The network’s duties included improving public understanding of stem cell clinical trials and therapies; entering into contracts with academic and corporate sponsors of stem cell clinical trials; and provide consulting services to those sponsors that were designed to “streamline and provide economies of scale for clinical, data management, and regulatory processes.”
“While all of the aims of the concept plan are individually laudable, it is my firm belief that the proposal as written is too broad and overly complex to be successful. In a word, it lacks focus,” Dr. Mills wrote in a memo to members of the governing board, formally called the Independent Citizens’ Oversight Committee (ICOC).
“As a result of its overly wide-ranging scope, I also believe that there is a real possibility of incurring significant duplicative costs,” Dr. Mills added. “It is my opinion that the $70 million price tag is not clearly justified in terms of the benefits it will deliver to the people of California.”
Instead, Dr. Mills proposed a revised concept plan for a scaled-back CIMC with a focus on early stage clinical operations, specifically efforts related to ensuring high-quality stem cell clinical trials. That center, he said, would open in an unspecified “limited number” of locations and evaluated for effectiveness before it is expanded. A single principal investigator would administer CIMC after demonstrating “appropriate management experience to provide leadership for CIMC staff, as well as across the network to facilitate network activities.”
Dr. Mills proposed that the stem-cell agency spend up to approximately $10 million to fund the revised CIMC for five years.