Lineage Cell Therapeutics has begun the DOSED study to assess the utility and safety of the Manual Inject Parenchymal Spinal Delivery System (MI PSD System) designed for direct delivery of oligodendrocyte progenitor cells 1 (OPC1) to spinal cord injury (SCI) sites.
An allogeneic stem cell-derived transplant, OPC1 helps restore or increase the functional activity in SCI patients.
It is tailored to replace the spinal cord cells that are either dysfunctional or not present due to traumatic injury.
The study will include both subacute and chronic SCI subjects, with the primary endpoint focusing on the severity and frequency of adverse events related to the system or injection procedure within the first month.
Secondary endpoints will evaluate adverse events over three months post-OPC1 injection, including those related to immunosuppression.
The company noted that the device is designed via an external partnership.
Lineage Cell Therapeutics CEO Brian Culley said: “Differentiated cell transplantation is a promising therapeutic approach, so it is a privilege that Lineage has received written clearance from the FDA to launch the DOSED study as part of our continued development of OPC1.
“In addition to the safety and performance of the new device, we also will be collecting functional assessments on all patients, which gives us the opportunity to investigate any signals of efficacy that may arise. The first study site will be UC San Diego Health.”
OPC1 has been evaluated in two prior clinical trials, demonstrating a long-term safety profile.
The initial Phase I trial involved five acute thoracic SCI subjects followed for a minimum of 13 years, and a multi-centre Phase I/IIa dose-escalation study with 25 subacute cervical SCI subjects, monitored for a minimum of seven years.
Continuous safety monitoring has revealed no unexpected serious adverse events that can be attributed to OPC1.
The California Institute for Regenerative Medicine, under Proposition 71, supported the OPC1 programme.
