
Lineage Cell Therapeutics Doses First Chronic SCI Patient in Landmark DOSED Study for Allogeneic Cell Therapy
CARLSBAD, Calif. – August 5, 2025 – Lineage Cell Therapeutics, a clinical-stage biotechnology company focused on cell therapies, announced today that it has successfully treated the first-ever chronic spinal cord injury (SCI) patient in its DOSED clinical study at UC San Diego Health. The milestone marks a significant expansion for the company’s investigational allogeneic cell therapy, OPC1, into a new and larger patient population.
“Differentiated cell transplantation is a promising therapeutic approach that is increasingly being validated in a wide range of diseases and conditions,” stated Brian M. Culley, Lineage’s CEO. “For this reason, it is exciting to advance the OPC1 program into further clinical testing and expand the OPC1-treated population to include chronic SCI patients, which represents a larger potential treatable population.”
OPC1 is an investigational, allogeneic stem cell-derived cell transplant comprised of oligodendrocyte progenitor cells. These cells are designed to replace or support the cells in the injured spinal cord that are absent or dysfunctional due to traumatic injury, with the goal of restoring or augmenting functional activity.
The DOSED study is designed to evaluate a novel delivery device engineered to administer OPC1 directly to the injury site. This new delivery method is more efficient and safer than previous methods and is compatible with a new “thaw-and-inject” formulation that simplifies the procedure. In addition to assessing the device’s performance, the company will collect functional assessments from all patients to investigate any signals of efficacy.
The OPC1 program has an extensive long-term safety record from two prior clinical trials, where some patients have been followed for over a decade with no unexpected serious adverse events. The therapy has been recognized by the U.S. Food and Drug Administration (FDA) with both Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations.
Source:
https://www.biospace.com/press-releases/lineage-announces-dosing-of-first-patient-in-new-clinical-study-of-opc1-for-subacute-and-chronic-spinal-cord-injury
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