Lineage Cell Therapeutics submits OPC1INDa to FDA

Lineage Cell Therapeutics announced that the company has submitted an investigational new drug amendment, or INDa, to the FDA, for OPC1, its investigational allogeneic oligodendrocyte progenitor cell transplant, for the treatment of spinal cord injury, or SCI. Receipt of FDA clearance of the INDa would enable the company to initiate its DOSED clinical study, to evaluate the safety and utility of a novel spinal cord delivery device in both subacute and chronic SCI patients. The OPC1 cell transplant is designed to replace or support cells that are absent or dysfunctional due to traumatic injury, with a goal to help improve the quality of life and restore or augment functional activity in persons suffering from traumatic cervical or thoracic SCIs.