OPC1
for Spinal Cord Injury
OPC1 is an allogeneic oligodendrocyte progenitor cell therapy designed to improve recovery following a spinal cord injury (SCI).
OPC1 is designed to replace or support cells in the injured spinal cord that are absent or dysfunctional due to traumatic injury and is intended to help restore or augment functional activity in persons suffering from an SCI. Improved functional activity can lead to greater mobility and enhanced quality of life for patients and significant cost-savings for caregivers.
OPC1 has an extensive long-term safety profile based on two clinical trials to date: a five-patient Phase 1 safety trial in acute thoracic SCI, where all active subjects have been followed for at least 14 years; and a 25-patient Phase 1/2a multicenter dose-escalation trial in subacute cervical SCI, where all active subjects have been evaluated for at least 8 years. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the U.S. Food and Drug Administration (FDA).
Lineage is currently enrolling participants in the DOSED (Delivery of Oligodendrocyte Progenitor Cells (OPCs) for Spinal Cord Injury: Evaluation of a Novel Device) clinical study. The DOSED study will evaluate the safety and utility of a novel delivery device developed to deliver OPC1 directly to the area of injury in patients with SCI. The DOSED study will enroll both subacute (between 21 to 42 days following injury) and chronic (between 1 to 5 years following injury) SCI patients.
Part 1
In 2016, Chris Block was paralyzed in a bicycling accident. In 2023, he is an avid scuba diver, horseback rider and, importantly, has his independence.
Part 2
In 2016, Chris Block was paralyzed in a bicycling accident. In 2023, he is an avid scuba diver, horseback rider and, importantly, has his independence.
In 2016, Jake Javier was paralyzed from the neck down. In late 2022, he is set to graduate from Duke University with his Master’s Degree in Biomedical Engineering, with plans to help those impacted by neurological injuries or diseases.
Highlighting the progress made by Kris Boesen and Lucas Lindner, both of whom received Lineage’s OPC1 cell therapy following traumatic spinal cord injury (SCI).
Expected Recovery1 vs OPC1: Motor Function Gains
View our pipeline to see our other programs in development.
References:
1. Steeves JD, Lammertse DP, Kramer JL, Kleitman N, Kalsi-Ryan S, Jones L, Curt A, Blight AR, Anderson KD. Outcome Measures for Acute/Subacute Cervical Sensorimotor Complete (AIS-A) Spinal Cord Injury During a Phase 2 Clinical Trial. Top Spinal Cord Inj Rehabil. 2012 Winter;18(1):1-14. doi: 10.1310/sci1801-1. Epub 2012 Jan 31. PMID: 23239927; PMCID: PMC3519288.
2. Fessler, R. G., Ehsanian, R., Liu, C. Y., Steinberg, G. K., Jones, L., Lebkowski, J. S., Wirth, E. D., III, & McKenna, S. L. (2022). A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury, Journal of Neurosurgery: Spine (published online ahead of print 2022). Retrieved Aug 19, 2022, from https://thejns.org/spine/view/journals/j-neurosurg-spine/aop/article-10.3171-2022.5.SPINE22167/article-10.3171-2022.5.SPINE22167.xml