Device to deliver LCTOPC1 into the spinal cord for people with cervical or thoracic injuries

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

This trial will test a new device that injects LCTOPC1 cells into the spinal cord of adults with recent or chronic cervical or thoracic spinal cord injuries to see if it can be given safely.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Lineage Cell Therapeutics, Inc. (Industry-sponsored)
• Locations: 2 sites (Downey, California and 1 other locations)
• Trial ID: NCT06841770 on ClinicalTrials.gov

What this trial studies

This is a Phase 1b, open-label, multi-center device safety study testing a one-time injection of LCTOPC1 delivered directly into the spinal cord using a novel delivery device. The study will enroll 3–5 participants with subacute injuries (21–42 days post-injury) and 3–5 with chronic injuries (1–5 years post-injury), all with AIS-A or AIS-B injuries at levels C4–T10 and at least one upper-extremity key muscle with 1/5 strength. The first four participants will be enrolled sequentially with safety checks between them, and participants will be followed for adverse events and clinical outcomes with monitoring extending up to 10 years. The primary focus is device and administration safety while collecting clinical and imaging data to inform later trials.

Who should consider this trial

Good fit: Ideal candidates are adults 18–65 with traumatic cervical or thoracic SCI (C4–T10) who are AIS-A or AIS-B, meet the timing windows for the subacute (21–42 days) or chronic (1–5 years) cohorts, have at least one upper-extremity key muscle at 1/5 strength, and can undergo elective surgery.

Not a fit: People who are under 18 or over 65, have injuries outside C4–T10, do not meet the required AIS grade or muscle-strength criteria, have multiple or poorly visualized injury sites, or cannot tolerate elective spinal procedures are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, this approach might help replace or support cells lost after injury and potentially improve motor or sensory function and overall quality of life.

How similar studies have performed: Early-phase human trials of oligodendrocyte progenitor or related cell therapies have produced limited safety data but no conclusive proof of restored function, so this builds on prior early human work rather than being entirely novel.

Eligibility criteria

Inclusion Criteria:

1. Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) or sensory incomplete, traumatic SCI (ASIA Impairment Scale B)
2. For subjects with subacute injury, International Standards for Neurological Classification of SCI (ISNCSCI) Neurological Level of Injury (NLI) from C-4 to T-10 occurring 21 to 42 days prior to LCTOPC1 injection
3. For subjects with chronic injury, ISNCSCI NLI from C-4 to T-10 and more than 30 days without clinical improvement from last assessment, occurring 1 to 5 years prior to LCTOPC1 injection
4. Individuals must have at least one upper extremity ISNCSCI key muscle with at least 1/5 strength
5. 18 through 65 years of age, inclusive, at time of consent
6. Single injury with sufficient visualization of the spinal cord injury epicenter and lesion margins to enable post-injection safety monitoring
7. Informed consent for this protocol must be provided and documented (i.e., signed ICF)
8. Able to participate in an elective surgical procedure to inject LCTOPC1 21 days or later following SCI
9. Female subjects of child-bearing potential must agree to the use of contraception for 1 year following LCTOPC1 injection; male subjects must agree to use contraception to prevent pregnancy in any female partners of child-bearing potential for 1 year following LCTOPC1 injection

Exclusion Criteria:

1. SCI due to penetrating trauma
2. Traumatic anatomical transection, laceration, or inadequate decompression of the spinal cord based on prior surgery or MRI
3. Any concomitant injury that interferes with the performance, interpretation, or validity of neurological examinations, such as multiple spinal cord lesions, brachial/lumbar plexus injury, cauda equina injury or traumatic brain injury
4. Subjects with a cavity structure that would preclude successful transplantation, as identified on MRI, which may include septations or irregularities in tissue structure
5. Persons with syringomyelia, defined as those with progressively enlarging cysts on T2-weighted images associated with neurological decline
6. Inability to communicate effectively with neurological examiner such that the validity of patient data could be compromised
7. Organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
8. Need for mechanical support of ventilation (ventilator, continuous positive airway pressure \[CPAP\], bi-level positive airway pressure \[BiPAP\]), excluding supplemental oxygen, at baseline
9. History of any malignancy (except non-melanoma skin cancers). For cancers in remission for more than five years, enrollment is allowed with concurred documented approval of principal investigator, oncologist, and Sponsor's medical monitor prior to enrollment
10. Pregnant or nursing women
11. Subjects with an implanted spinal cord stimulator (SCS), whether temporary or permanent.

Where this trial is running

Downey, California and 1 other locations

• Rancho Research Institue — Downey, California, United States (Not_yet_recruiting)
• University of California, San Diego — La Jolla, California, United States (Recruiting)

Study contacts

• Study coordinator: Reference Study ID Number: LCTOPC1-SCI-03 https://lineagecell.com/products-pipeline/opc1/

Conditions Spinal Cord Injury Cervical; Spinal Cord Injury Thoracic; Spinal Cord Injury, Acute; Spinal Cord Injury; Spinal Cord Injury, Chronic; DOSED; Subacute spinal cord injury; Oligodendrocyte Progenitor Cell