Lineage Cell Therapeutics has launched the DOSED clinical study to evaluate the safety and effectiveness of a new spinal cord injury (SCI) treatment delivery system. The study will examine the Manual Inject Parenchymal Spinal Delivery System (MI PSD System) designed to deliver OPC1, an investigational stem cell-derived therapy, directly to the injury site in patients with subacute (21-42 days post-injury) and chronic (1-5 years post-injury) SCI. This is the third clinical trial for OPC1 and the first to include chronic SCI patients, a substantially larger patient group.
This research holds significant potential for advancing SCI treatment. Currently, there are no FDA-approved treatments specifically for SCI, a condition with approximately 18,000 new cases annually in the US, leaving over 300,000 individuals living with the debilitating consequences. Successful implementation of a safe and effective cell delivery system combined with a promising therapy like OPC1 could revolutionize the treatment landscape, offering hope for improved functional recovery and quality of life for a large patient population.
The DOSED study will enroll participants with complete or incomplete traumatic SCI affecting the cervical or thoracic vertebrae. The primary objective is to evaluate the safety of the MI PSD System, tracking adverse events related to the device and injection procedure within 30 days. Secondary endpoints extend the safety evaluation to 90 days and include monitoring adverse events related to OPC1 and the accompanying immunosuppression. The study will also explore potential efficacy signals by assessing changes in neurological function, pain levels, and quality of life over one year. This study utilizes a new immediate-use formulation of OPC1, simplifying prior dose preparation procedures.
This study’s initiation marks a critical step forward in SCI research. Positive safety and efficacy data from the DOSED study, coupled with the inclusion of chronic SCI patients, could pave the way for broader clinical application and potentially regulatory approval. This holds significant implications for the future of SCI care, offering the possibility of a novel therapeutic approach for this currently underserved patient population.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
