Designation will help speed development of treatments.
In a push to further speed clinical development of emerging stem cell therapies, Sanford Stem Cell Clinical Center at UC San Diego Health System and a joint UC Irvine-UCLA alliance were named today (Oct. 23) two of three new “alpha clinics” by the state’s stem cell agency.
The announcement, made at a public meeting in Los Angeles of the California Institute for Regenerative Medicine Governing Board, includes an award of $8 million for each of the three sites. The other alpha grant recipient is the City of Hope hospital near 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 Dr. Catriona Jamieson, 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.
Meanwhile, UCLA’s Eli & Edythe Broad Center of Regenerative Medicine & Stem Cell Research and UC Irvine’s Sue & Bill Gross Stem Cell Research Center will launch a collaborative stem cell clinic. The joint entity will conduct clinical trials of investigational stem cell therapies and provide critical resources and expertise via the creation of a world-class, state-of-the-art infrastructure supporting clinical research.
The grant reviewers lauded the UCLA/UCI consortium’s “impressive and multidimensional team of experienced personnel” that will expand “access to patients, attracting national and international clinical trials and accelerating future trials in the pipeline.”
The initial stem cell trials supported by the UCLA/UCI Alpha Stem Cell Clinic will be two UCLA projects using blood-forming stem cells. The first trial will test a stem cell-based gene therapy for patients with “bubble baby disease,” also called severe combined immune deficiency, in which babies are born without an immune system. Under the direction of Dr. Donald Kohn, the clinical trial will use the baby’s own stem cells with an inserted gene modification to correct the defect and promote the creation of an immune system. The second clinical trial, under the direction of Dr. Antoni Ribas, will use a patient’s own genetically modified blood-forming stem cells to engineer and promote an immune response to melanoma and sarcomas.
“This CIRM Alpha Stem Cell Clinic grant is an important acknowledgement of our cutting-edge research and will help us to advance the design, testing and delivery of effective and safe stem cell-based therapies,” said Dr. Owen Witte, professor and director of the Broad Stem Cell Research Center. “The implementation of a standard of excellence in clinical research will improve healthcare and the lives of patients far beyond the longevity of individual trials.”
Potential clinical studies at UCI, such as those being considered for retinitis pigmentosa and stroke, will also be supported by the clinic.
“UCI has established a strong preclinical stem cell research program, and it’s vital to move ahead to the clinical testing phase,” said Sidney Golub, director of the UCI Sue and Bill Gross Stem Cell Research Center. “To advance treatments in this field, we all have to work together, and that’s what the UCLA-UCI Alpha Stem Cell Clinic program represents.”