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

Last updated: February 11, 2026
Sponsor: Lineage Cell Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Limb Spasticity

Spinal Cord Disorders

Spinal Cord Injuries

Treatment

OPC1

Clinical Study ID

NCT06841770
LCTOPC1-SCI-03
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) or sensoryincomplete, traumatic SCI (ASIA Impairment Scale B)

  2. For subjects with subacute injury, International Standards for NeurologicalClassification of SCI (ISNCSCI) Neurological Level of Injury (NLI) from C-4 to T-10occurring 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 dayswithout clinical improvement from last assessment, occurring 1 to 5 years prior toLCTOPC1 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 andlesion margins to enable post-injection safety monitoring

  7. Informed consent for this protocol must be provided and documented (i.e., signedICF)

  8. Able to participate in an elective surgical procedure to inject LCTOPC1 21 days orlater following SCI

  9. Female subjects of child-bearing potential must agree to the use of contraceptionfor 1 year following LCTOPC1 injection; male subjects must agree to usecontraception to prevent pregnancy in any female partners of child-bearing potentialfor 1 year following LCTOPC1 injection

Exclusion

Exclusion Criteria:

  1. SCI due to penetrating trauma

  2. Traumatic anatomical transection, laceration, or inadequate decompression of thespinal cord based on prior surgery or MRI

  3. Any concomitant injury that interferes with the performance, interpretation, orvalidity 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, asidentified on MRI, which may include septations or irregularities in tissuestructure

  5. Persons with syringomyelia, defined as those with progressively enlarging cysts onT2-weighted images associated with neurological decline

  6. Inability to communicate effectively with neurological examiner such that thevalidity of patient data could be compromised

  7. Organ damage or systemic disease that would create an unacceptable risk for surgeryor immunosuppression

  8. Need for mechanical support of ventilation (ventilator, continuous positive airwaypressure [CPAP], bi-level positive airway pressure [BiPAP]), excluding supplementaloxygen, at baseline

  9. History of any malignancy (except non-melanoma skin cancers). For cancers inremission for more than five years, enrollment is allowed with concurred documentedapproval of principal investigator, oncologist, and Sponsor's medical monitor priorto enrollment

  10. Pregnant or nursing women

  11. Subjects with an implanted spinal cord stimulator (SCS), whether temporary orpermanent.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: OPC1
Phase: 1
Study Start date:
June 30, 2025
Estimated Completion Date:
June 30, 2037

Study 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.

Connect with a study center

  • University of California, San Diego

    La Jolla, California 92037
    United States

    Site Not Available

  • Rancho Research Institue

    Downey 5343858, California 5332921 90242
    United States

    Site Not Available

  • University of California, San Diego

    La Jolla 5363943, California 5332921 92037
    United States

    Active - Recruiting

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