Actively Recruiting
Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury Using a Novel Device (DOSED Study)
Led by Lineage Cell Therapeutics, Inc. · Updated on 2026-02-12
10
Participants Needed
2
Research Sites
516 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants With Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sensorimotor complete (AIS-A) or sensory incomplete (AIS-B) traumatic spinal cord injury
- Subacute injury with neurological level from C4 to T10 occurring 21 to 42 days before injection
- Chronic injury with neurological level from C4 to T10 and no clinical improvement 1 to 5 years before injection
- At least one upper extremity key muscle with strength of 1/5 or more
- Age between 18 and 65 years at time of consent
- Single injury with clear visualization of spinal cord injury site for safety monitoring
- Ability to provide informed consent
- Ability to undergo elective surgery for LCTOPC1 injection at least 21 days after injury
- Agreement to use contraception for 1 year after injection if of child-bearing potential
You will not qualify if you...
- Spinal cord injury caused by penetrating trauma
- Anatomical transection, laceration, or inadequate spinal cord decompression
- Other injuries interfering with neurological exams, such as multiple spinal cord lesions, plexus injury, cauda equina injury, or brain injury
- Presence of cavity structures preventing transplantation, including septations or irregular tissue
- Syringomyelia with progressive cyst enlargement and neurological decline
- Inability to communicate effectively with neurological examiners
- Organ damage or systemic illness posing surgical or immunosuppression risk
- Need for mechanical ventilation support (excluding supplemental oxygen)
- History of malignancy except certain skin cancers, unless approved after remission
- Pregnancy or nursing
- Implanted spinal cord stimulator device, temporary or permanent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - One-time injection with immediate recovery period
Participants receive a one-time injection of LCTOPC1 cells using a novel delivery device to the damaged spinal tissue.
1 visit (in-person) for injection and monitoring
Duration - Up to 10 years following the injection
Participants are monitored for safety and potential adverse events related to the delivery device and LCTOPC1 injection.
Regular follow-up visits over 10 years
Trial Site Locations
Total: 2 locations
1
Rancho Research Institue
Downey, California, United States, 90242
Not Yet Recruiting
2
University of California, San Diego
La Jolla, California, United States, 92037
Actively Recruiting
Research Team
R
Reference Study ID Number: LCTOPC1-SCI-03 https://lineagecell.com/products-pipeline/opc1/
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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