Lineage Cell Therapeutics, Inc. announced the clearance, by the U.S. Food and Drug Administration (FDA), of its Investigational New Drug amendment (INDa) for OPC1, an investigational allogeneic oligodendrocyte progenitor cell transplant for the treatment of spinal cord injury (SCI). Pursuant to the INDa, Lineage has initiated activities to open its first clinical site in the DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) study to evaluate the safety and utility of a novel spinal cord delivery device in subacute and chronic SCI patients. Initial site opening is expected to occur in the second quarter of 2024, following customary trial preparations and submission in the first quarter of a grant application to the California Institute for Regenerative Medicine (CIRM) for potential partial financial support of the DOSED clinical study.

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.