Safety Study of a New Delivery Device Injecting LCTOPC1 Cell Therapy for Adults with Cervical or Thoracic Spinal Cord Injuries

What this Trial Is About

Researchers are evaluating the safety and usefulness of a new delivery device designed to inject LCTOPC1, a cell therapy, into the spinal cord of people with spinal cord injuries SCI. LCTOPC1 aims to replace or support cells lost or damaged due to trauma, with the goal of improving quality of life and helping restore or enhance function in individuals with cervical or thoracic SCI. This Phase 1b, open-label, multi-center study focuses on both subacute and chronic SCI patients with specific injury types and locations. The study involves a one-time injection of 10 million LCTOPC1 cells administered via the novel delivery device directly to the injured spinal cord tissue. Participants include those with subacute injuries occurring 21 to 42 days before treatment and those with chronic injuries from 1 to 5 years prior. The first four participants will be enrolled sequentially after safety criteria are met. The injection is given during an elective surgical procedure, and the study monitors safety over a long-term period. Participants will undergo close monitoring for safety, including assessments of adverse events related to the device and injection procedure up to 30 days, and additional evaluations of adverse events related to LCTOPC1 and immunosuppression up to 90 days. MRI scans will assess any changes in spinal cord condition at 90 days. The study plans to follow participants for up to 10 years after treatment to track long-term safety and outcomes.

A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants With Spinal Cord Injury