Designation will help speed development of emerging drugs and therapies
In a push to further speed clinical development of emerging stem cell therapies, Sanford Stem Cell Clinical Center at UC San Diego Health System was named today one of three new "alpha clinics" by the California Institute for Regenerative Medicine (CIRM), the state's stem cell agency.
The announcement, made at a public meeting in Los Angeles of the CIRM Governing Board, includes an award of $8 million for each of three sites. The other alpha grant recipients are the City of Hope hospital near Los Angeles and University of California, Los Angeles.
"A UC San Diego alpha clinic will provide vital infrastructure for establishing a comprehensive regenerative medicine clinical hub that can support the unusual complexity of first-in-human stem cell-related clinical trials," said Catriona Jamieson, MD, PhD, associate professor of medicine at UC San Diego School of Medicine, deputy director of the Sanford Stem Cell Clinical Center, director of the UC San Diego Moores Cancer Center stem cell program and the alpha clinic grant's principal investigator.
"The designation is essential in much the same manner that comprehensive cancer center status is an assurance of scientific rigor and clinical quality. It will attract patients, funding agencies and study sponsors to participate in, support and accelerate novel stem cell clinical trials and ancillary studies for a range of arduous diseases."
The alpha clinics are intended to create the long-term, networked infrastructure needed to launch and conduct numerous, extensive clinical trials of stem cell-based drugs and therapies in humans, including some developed by independent California-based investigators and companies. These trials are requisite before any new drug or treatment can be approved for clinical use.
The clinics will also emphasize public education to raise awareness and understanding of stem cell science – in part to combat "stem cell tourism" and the marketing of unproven, unregulated and potentially dangerous therapies – and help establish sustainable business models for future, approved stem cell treatments.
"Everything we do has one simple goal, to accelerate the development of successful treatments for people in need," said C. Randal Mills, PhD, CIRM president and CEO. "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 alpha clinic grant reflects continued CIRM support for UC San Diego's well-established stem cell research and development programs. Since it was created in 2004, CIRM has approved 74 awards totaling almost $156 million to UC San Diego stem cell scientists and programs.
"These alpha clinic awards not only provide valuable support that will help accelerate experimental stem cell therapies into clinical trials, they also bring with them a 'stamp of approval' that our center meets important standards set by peers for testing of stem cell therapy trials," said Lawrence Goldstein, PhD, director of the UC San Diego Sanford Stem Cell Clinical Center and of the UC San Diego Stem Cell Program.
Recently, under the auspices of the Sanford Center, UC San Diego researchers and industry collaborators launched three first-in-human clinical trials to pursue unprecedented stem cell-based treatments for spinal cord injuries, Type 1 diabetes and chronic lymphocytic leukemia. Other trials for heart failure, amyotrophic lateral sclerosis (Lou Gehrig's disease), blindness and other conditions and diseases are in planning stages.
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