Cedars-Sinai has been awarded a five-year, $8 million grant from California’s stem cell agency to launch an innovative new clinic that will expand patients’ access to stem cell and gene therapies, increase research and training in regenerative medicine, foster greater collaboration with eight similar clinics across the state and help educate the public about stem cell and related therapies.
The California Institute for Regenerative Medicine (CIRM) approved Cedars-Sinai’s plan to establish an Alpha Stem Cell Clinic, bringing Cedars-Sinai into a network of Alpha sites throughout California. The Cedars-Sinai clinic will develop preclinical studies into early and later phase clinical trials with the goal of establishing advanced regenerative medicine treatments that are FDA-approved for patients with debilitating diseases.
The Cedars-Sinai initiative is being led by the Cedars-Sinai Board of Governors Regenerative Medicine Institute and the Smidt Heart Institute. They are modeling the new Alpha Clinic on a jointly run Regenerative Medicine Clinic established at Cedars-Sinai in 2014—expanding scientific discovery and clinical trials for neurological, cardiovascular, musculoskeletal and autoimmune diseases.
“We are thrilled to join the Alpha Stem Cell Clinic Network as we use novel stem cell and gene therapy approaches to reach a more diverse group of patients with debilitating conditions that have no cure and high morbidity and mortality because of limitations to current therapeutic approaches, said Michael Lewis, MD, program director of the Alpha Clinic, a professor of Medicine at Cedars-Sinai and member of the Department of Medicine’s Pulmonary and Critical Care Division, Board of Governors Regenerative Medicine Institute and the Smidt Heart Institute.
“We are most grateful to CIRM for this generous grant that will allow us to advance leading-edge science and patient care,” Lewis added. “Collaborative efforts with the Alpha network, many spearheaded by Cedars-Sinai, will produce exciting and promising outcomes that will be far greater than the sum of the individual parts.”
A broad collaboration of scientific and operational teams across the Cedars-Sinai academic enterprise will support the new clinic. Biomanufacturing facilities will produce regenerative medicine stem cell products for clinical trials. Leaders in computational biomedicine will help Cedars-Sinai and the broader Alpha network manage data through informatics, artificial intelligence and machine learning.
An advanced proteomics team will study protein patterns in disease and identify biomarker proteins. An advanced imaging group will contribute research in preclinical trials and patient trials and develop novel imaging techniques. Cedars-Sinai’s Institutional Review Board (IRB) will provide study monitoring for Alpha network sites and other key IRB regulatory efforts such as reliance procedures, electronic consents and language accessibility.
The Alpha Clinic will also build on Cedars-Sinai’s existing graduate education programs with new exciting courses. These will include a master’s degree program in regenerative medicine and will offer advanced training for residents, fellows, junior faculty, nursing staff, postdoctoral scientists, research pharmacy staff and others. Furthermore, educational programs will be implemented for the public to better understand stem cell and gene therapies for complex disease.
“Cedars-Sinai’s robust infrastructure will support a high level of bench-to-bedside inquiry and provide collaborative support for stem cell science across the Alpha network,” said Clive Svendsen, PhD, executive director of the Regenerative Medicine Institute and associate program director of the Alpha Clinic. “We are excited to contribute our expertise and energy to this promising new enterprise.”
Alpha Clinic leaders are confident that the collaborative approach will accelerate scientific discovery, clinical advances and training at Cedars-Sinai, and help propel similar achievement across CIRM’s larger statewide effort.
“We are excited to join CIRM’s Alpha Clinic network,” said Eduardo Marbán, MD, PhD, executive director of the Smidt Heart Institute and associate program director of the Alpha Clinic. “As the top-ranked hospital in California by U.S. News & World Report, Cedars-Sinai brings extensive talent, innovative technologies and a vibrant portfolio of clinical studies in regenerative medicine to the network.”
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