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Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 65

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

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

Run by Lineage Cell Therapeutics, Inc. · NCT06841770 · Data updated 2026-11-12

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.

More Spinal Cord Injury trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment10 (estimated)
SponsorLineage Cell Therapeutics, Inc.
Industry-sponsored
Locations2 sites (Downey, California and 1 other locations)
StatusRecruiting
StartedJune 30, 2025
Main results expectedAugust 10, 2027
Study endsJune 30, 2037
Registry record updatedFebruary 12, 2026
Trial IDNCT06841770 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • University of California, San Diego
    La Jolla, California, United States     Recruiting
  • Rancho Research Institue
    Downey, California, United States     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.