The California Institute for Regenerative Medicine today awarded a nearly $8 million grant to University of California, Davis, stem cell researchers to launch a special clinical trials program in Sacramento to accelerate the therapeutic development and delivery of stem cell therapies in human patients.
The new "Alpha Clinic Award" enables UC Davis to become a Northern California site for the state stem cell agency’s Alpha Stem Cell Clinics Network – a consortium of top-tier institutions tasked with expanding enrollment in stem cell clinical trials throughout the state.
The network is focused on developing new resources and taking advantage of existing research expertise – such as UC Davis’ multidisciplinary stem cell work at its Sacramento and Davis campuses – to address the unique challenges and needs of taking novel investigational stem cell products from the laboratory bench to a patient’s bedside.
"We have the full-range of expertise in regenerative medicine, from the cellular to the clinical trials level," said Jan Nolta, director of the university’s stem cell program and the UC Davis Institute for Regenerative Cures. "We’re excited about the prospects of linking with the other Alpha clinics to speed the process of testing and refining treatments so we can get them to the patients who need them. It’s what we’ve always looked at as ‘turning stem cells into cures."
UC Davis, which has received more than $130 million in CIRM funding over the past decade, has successfully explored a wide range of potential stem cell therapies, from advanced wound healing, treating HIV, and reduced vision loss to the regeneration of bone in otherwise non-healing fractures.
The Alpha Clinic will provide a centralized space and personnel at UC Davis Medical Center in Sacramento to administer stem cells and immunotherapy, conduct follow-up visits and manage biospecimens. This new clinic is being established as a centralized, trusted destination for patients in Northern and Central California. It also includes a specialized "Fellows Training Program" for physicians to gain the full spectrum of skills needed to conduct clinical trials using stem cells.
In assessing UC Davis’ grant proposal, CIRM grant reviewers also noted the university’s unique good manufacturing practice (GMP) facility and expertise as well as its long history in telehealth.
The GMP facility manufactures stem cell, gene and immunotherapy products for numerous partners, and features six manufacturing rooms with commercial grade, multi-use cleanroom capabilities, as well as an associated product scale-up and testing lab. Such elements are crucial in safely developing stem cell therapies for large-scale use.
The UC Davis Telehealth Program — which offers secure video conferencing in the medical environment — has been providing patient care at numerous sites throughout California for more than 20 years. CIRM reviewers identified it as a distinctive asset for the Alpha network’s goal of reaching more potential clinical participants and being able to monitor their progress remotely.
"Our robust translational and clinical science programs and expertise, combined with our proven telehealth network and capabilities, were a natural fit for the Alpha network team," said Thomas Nesbitt, associate vice chancellor for Strategic Technologies and Alliances and interim vice chancellor for Human Health Sciences at UC Davis Health. "Stem cells may provide help for diseases and injuries that otherwise have no answers. We look forward to being part of a team that is focused on expanding the reach and success of regenerative medicine therapies."
In addition to Nolta, the principal investigator for the UC Davis Alpha Clinic project is Mehrdad Abedi, professor of internal medicine and a specialist in bone marrow transplantation.
During today’s CIRM meeting, voting members also approved funding for new Alpha Clinic at UC San Francisco, which also adds to the current network sites at City of Hope, UCLA-UC Irvine and UC San Diego.