Extensive preclinical testing of AST-OPC1 (formerly GRNOPC1) in animal models of traumatic SCI demonstrated that these cells survive, migrate throughout the injury site, and improve locomotor function. Therefore, a phase 1 clinical trial was initiated to assess the safety of AST-OPC1 in patients with neurologically complete, T3-T11 thoracic SCI. Five subjects received a low dose of two million AST-OPC1 cells between 7 and 14 days following their injury. The cells were administered via a single injection into the spinal cord lesion using a dedicated syringe positioning device. To date, all five subjects have been followed for over 3 years, and no significant safety concerns related to AST-OPC1 or the injection procedure have been noted. Serial MRI scans showed that lesion cavity formation at the AST-OPC1 injection sites was substantially reduced through 3 years of follow up in 4 of 5 subjects. There were no clinically significant changes in neurological function observed in any of the subjects. Based on these encouraging safety data, a Phase 1/2a trial was recently initiated to evaluate the safety and activity of escalating doses of AST-OPC1 in patients with sub-acute sensorimotor complete cervical SCI. The first participant in this trial received AST-OPC1 in June, 2015.
The first participant in this trial received AST-OPC1 in June, 2015, but the most recent update on October 20th, 2015 of that first participant can be found at this LINK.
Edward D. Wirth III, MD, PhD, Chief Medical Officer, Asterias Biotherapeutics. Dr. Wirth is the Chief Medical Officer and joined Asterias Biotherapeutics in March of 2013 after serving as Chief Science Officer at InVivo Therapeutics Corporation from 2011 to 2012. From 2004 to 2011, Dr. Wirth served as Medical Director for Regenerative Medicine at Geron Corporation, where he led the world’s first clinical trial of a hES cell-derived product, GRNOPC1, in patients with subacute spinal cord injuries. Dr. Wirth held academic appointments at Rush-Presbyterian St. Luke’s Medical Center and at the University of Chicago from 2002 to 2004, and was a member of the faculty of the University of Florida from 1996 to 2002. Dr. Wirth received his Ph.D. and M.D. from the University of Florida in 1992 and 1994, respectively.