$8 million grant awarded to new US stem cell clinic

Cedars-Sinai has been awarded an $8 million grant over five years by the California Institute for Regenerative Medicine (CIRM), a US stem cell agency, to launch Alpha Stem Cell Clinic, intended to increase research and training in regenerative medicine, improve collaboration with eight similar Californian clinics and offer patients wider access to stem cell and gene therapies.

The clinic will develop pre-clinical studies into early and late phase clinical trials to identify US Food and Drug Administration (FDA)-approved advanced regenerative medicines. The organisation considers collaboration will advance scientific discovery, clinical advances and training.

The Cedars-Sinai Board of Governors Regenerative Medicine Institute and the Smidt Heart Institute will lead the project. The advanced facility will be based on the Regenerative Medicine Clinic established at Cedars-Sinai in 2014, developing clinical trials for neurological, cardiovascular, musculoskeletal and autoimmune diseases.

The Alpha Clinic will also support Cedars-Sinai’s already established graduate education programmes by offering key courses like a master’s degree in regenerative medicine. Research and academic staff will also be offered advanced training.

Planned projects and the teams involved in the new stem cell clinic

• Experts in computational biomedicine will manage data using informatics, artificial intelligence (AI) and machine learning
• Regenerative medicine stem cell products will be produced for clinical trials at biomanufacturing facilities
• Cedars-Sinai’s Institutional Review Board (IRB) will monitor the studies for Alpha network sites. The group will also monitor regulatory practices such as reliance procedures, electronic consents and language accessibility
• Scientific and operational teams.

The Alpha Clinic will “use novel stem cell and gene therapy approaches to [help more] patients with… conditions that have no cure and high morbidity and mortality [due] to current therapeutic [limits],” stated Dr Michael Lewis, Program Director of Alpha Clinic, 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.