Actively Recruiting
A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants With Spinal Cord Injury
Led by Lineage Cell Therapeutics, Inc. · Updated on 2026-02-12
10
Participants Needed
2
Research Sites
626 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Traumatic spinal cord injury classified as sensorimotor complete (ASIA Impairment Scale A) or sensory incomplete (ASIA Impairment Scale B)
- Injury located from cervical vertebra C4 to thoracic vertebra T10
- Subacute injury occurring 21 to 42 days before treatment or chronic injury 1 to 5 years before treatment without clinical improvement
- At least one upper extremity key muscle with strength of 1/5 or greater
- Age between 18 and 65 years at the time of consent
- Single injury with clear visualization of the spinal cord injury site for safety monitoring
- Provide documented informed consent
- Able to undergo elective surgery for LCTOPC1 injection at least 21 days after injury
- Agree to use contraception for one 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 decompression of spinal cord based on surgery or MRI
- Other injuries interfering with neurological exams, such as multiple spinal lesions, brachial/lumbar plexus injury, cauda equina injury, or brain injury
- Presence of cavity structures in spinal cord preventing transplantation
- Syringomyelia with enlarging cysts and neurological decline
- Inability to communicate effectively for neurological assessment
- Organ damage or systemic disease posing risk for surgery or immunosuppression
- Need for mechanical ventilation support at baseline (excluding supplemental oxygen)
- History of any malignancy except non-melanoma skin cancer, unless in remission over 5 years with approvals
- Pregnancy or nursing
- Implanted spinal cord stimulator (temporary or permanent)
AI-Screening
AI-Powered Screening
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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/
CONTACT
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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