Lineage Cell Therapeutics, Inc. announced that the Company has submitted an Investigational New Drug amendment (INDa) to the U.S. Food and Drug Administration (FDA), for OPC1, its investigational allogeneic oligodendrocyte progenitor cell transplant, for the treatment of spinal cord injury. Receipt of FDA clearance of the INDa would enable the Company to initiate its DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study, to evaluate the safety and utility of a novel spinal cord delivery device in both subacute and chronic SCI patients. OPC1 has been tested in two clinical trials to date; a five patient Phase 1 clinical safety trial in acute thoracic SCI, where all subjects have been followed for at least 10 years; as well as a 25 patient Phase 1/2a multicenter dose-escalation clinical trial in subacute cervical SCI, where all subjects were evaluated for at least two years, one of the first cell therapy clinical trials supported by the California Institute for Regenerative Medicine under Proposition 71.

Results from both studies have been published in the Journal of Neurosurgery: Spine: the data from the Phase 1/2a clinical study of OPC1 in subacute cervicalSCI is available here and the data from the Phase 1 clinical study of OPC1 In acute thoracic SCI is available here. The Delivery of OligodendroCyte Progenitor Cells forSpinal Cord Injury: Evaluation of an Novel Device (DOSED) clinical study is an open label, multi-center, device safety study, in approximately 3-5 subacute and 3-5 stable chronic subjects with complete (ASIA Impairment Scale A) or incomplete (ASIA Impairment scale B), traumatic, focal SCI affecting either cervical (C4-C7) or thoracic (T1-T10) vertebrae. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the U.S. Food & Drug Administration (FDA).