Stem Cell Agency Unveils CIRM 2.0 – its Aggressive Plan to Significantly Accelerate Promising Therapies. Invests $24 Million To Create Alpha Clinic Network

Los Angeles, CA – The California Institute for Regenerative Medicine (CIRM), the state’s Stem Cell Agency, today took two important steps towards speeding up the development of effective treatments for patients in need.

First, C. Randal Mills, Ph.D., the agency’s President & CEO, unveiled the Agency’s plans for CIRM 2.0, detailing an approach that would dramatically reduce the amount of time it takes to approve funding for a potential therapy heading into a clinical trial.

“Right now it can take almost two years for a promising idea to go from the application to the final funding stage. That’s just unacceptable,” says Mills. “We are going to shorten that to just 120 days. But we’re not just making it faster, we’re also making it easier for companies or institutions with a therapy that is ready to go into clinical trials to be able to get funding for their project when they need it. Under this new system they will be able to apply anytime, and not have to try and shoehorn their needs into our application process.”

Mills says the more streamlined process will start with projects ready for clinical trials but, with Board approval, a variation on the process will eventually be extended to all other areas of research that the Agency funds.

“Speeding up the process is only one part of CIRM 2.0,” says Mills. “We also want a process that ultimately delivers higher quality programs.  The goal is not just faster, but also better investments that have the greatest opportunity to provide patients with effective treatments.”

The Agency’s governing Board also voted to award $24 million to set up three new clinical trial centers. The awards, part of the Agency’s Alpha Stem Cell Clinics program, are to create one-stop centers for clinical trials enabling patients to have safe, fast and easy access to life-saving or life-changing stem cell therapies.

“Everything we do has one simple goal, to accelerate the development of successful treatments for people in need,” says Mills. “Stem cell therapies are a new way of treating disease; instead of managing symptoms, cellular medicine has the power to replace or regenerate damaged tissues and organs. And so we need to explore new and innovative ways of accelerating clinical research with stem cells. That is what we hope these Alpha Stem Cell Clinics will accomplish.”

The clinics will be centers of excellence that will not only have the clinical and regulatory expertise needed to deliver what, in many cases, will be the first-in-human clinical trials, but will also have the trained personnel, state of the art facilities and the support, patient care coordination and long-term follow-up that these therapies need.

The awards of $8 million each go to the City of Hope near Los Angeles, the University of California, Los Angeles and the University of California, San Diego.

The Board also voted to continue funding for another year the Creativity Awards and the CIRM Bridges to Stem Cell Research Awards programs. The Creativity program gives high school students, many from poor and low-income communities, a paid summer internship to help introduce them to stem cell research. The Bridges program offers research and training opportunities for undergraduate or Master’s level students to develop a skilled workforce for stem cell research in California.

About CIRM: CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research.

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