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Home/Biologics/California Stem Cell Agency Launches CIRM 2.0
Biologics

California Stem Cell Agency Launches CIRM 2.0

January 9, 2015 2 min read Premium comments

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California Stem Cell Agency Launches CIRM 2.0
Source: Wikimedia Commons and Databese Center for Life Science (DBCLS)
Secondary

The California Stem Cell Agency, created to accelerate stem cell treatments to patients with unmet medical needs, is announcing the launch of CIRM (California Institute for Regenerative Medicine) 2.0.

“Our mission is to accelerate the development of stem cell therapies for patients with unmet medical needs. Today, in officially launching the first three programs under CIRM 2.0, we have boldly reaffirmed our commitment to continuously seek new and innovative ways to better serve that mission, ” said C. Randal Mills, Ph.D., the president and CEO of CIRM, California’s stem cell agency, in the December 31, 2014 news release.

According to the news release, CIRM 2.0 is a “radical overhaul of the way the Agency does business.” The process will be faster, and the agency will be an active investor. “Each project will be partnered with a project-specific Clinical Advisory Panel (CAP) to help advise and guide it forward. Importantly, every panel will include at least one patient advisor with first-hand experience of the specific condition, who will provide input, recommendations and the appropriate sense of urgency that can only come from the unique perspective of someone living with the disease.”

Asked what orthopedic researchers would be particularly interested to know, Dr. Mills told OTW, “First, we have reduced the time from application to funding from 22 months to just 120 days, making it one of the more efficient sources of capital available. Second, the program is not just limited to cell therapies. Small molecule and biologics that have an effect on endogenous stem cells as the primary mechanism of action are also eligible. Lastly, the program is open to applicants from outside of the state of California. We want to attract exceptional technologies into California, so obviously the best deal we will offer is to those who are located here or are moving into the state. But if you are located outside of the state, we will partner with you on those activities that can be accomplished within California.”

Looking toward the next year at CIRM, Dr. Mills added, “This first phase of CIRM 2.0 targets clinical stage programs. We are investing $50 million in these projects during the first six months of 2015 alone. In 2015 we also intend expanding the program to include earlier stage projects in the discovery and translational stages. With close to $1 billion in reserve we have the resources we need to make these programs effective and successful. Our mission at CIRM is to accelerate the development of successful therapies for patients with unmet medical needs. CIRM 2.0 will help us do that and we want everyone with a promising stem cell therapy to know that we are open for business.”

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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