NCT06841770

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

Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device (DOSED)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Lineage Cell Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The DOSED clinical study evaluates the safety and utility of a novel delivery device to deliver LCTOPC1, a cell therapy, to the spinal cord of patients with a spinal cord injury (SCI). LCTOPC1 is designed to replace or support cells that are absent or dysfunctional due to traumatic injury, with a goal to help improve the quality of life and restore or augment functional activity in persons suffering from a traumatic cervical or thoracic injuries.

Detailed description

LCTOPC1-SCI-03 DOSED study is a Phase 1b, open-label, multi-center, device safety study designed to assess the safety of a novel delivery device for administering a one-time injection of LCTOPC1. The study will enroll 3-5 participants with subacute (21 to 42 days post-injury) spinal cord injuries and 3-5 participants with chronic (1 to 5 years post-injury) spinal cord injuries. Eligible participants must have either sensorimotor complete (AIS-A) or motor complete / sensory incomplete spinal cord injuries (AIS-B), located in the cervical (C4-C7) or thoracic (T1-T10) regions. The first four patients will be enrolled sequentially subsequent to meeting safety requirements. Participants will be monitored for long-term safety for up to 10 years following the administration of LCTOPC1.

Conditions

• Spinal Cord Injury Cervical
• Spinal Cord Injury Thoracic
• Spinal Cord Injury, Acute
• Spinal Cord Injury
• Spinal Cord Injury, Chronic

Interventions

Type	Name	Description
BIOLOGICAL	OPC1	One injection of 10 million LCTOPC1 cells will be delivered to the target injection site of the damaged spinal tissue.

Timeline

• Start date: 2025-06-30
• Primary completion: 2027-08-10
• Completion: 2037-06-30
• First posted: 2025-02-24
• Last updated: 2026-02-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study