A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants With Spinal Cord Injury
Recruiting now · Phase 1
Conditions studied: Spinal Cord Injury Cervical, Spinal Cord Injury Thoracic, Spinal Cord Injury, Acute, Spinal Cord Injury, Spinal Cord Injury, Chronic
In brief
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.
Key facts
- Study ID
- NCT06841770
- Run by
- Lineage Cell Therapeutics, Inc.
- People needed
- 10
- Starts
- 2025-06-30
- Expected to finish
- 2037-06-30
- Last updated by the study team
- 2026-02-12
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) or sensory incomplete, traumatic SCI (ASIA Impairment Scale B)
- 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
- 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
- Individuals must have at least one upper extremity ISNCSCI key muscle with at least 1/5 strength
- 18 through 65 years of age, inclusive, at time of consent
- Single injury with sufficient visualization of the spinal cord injury epicenter and lesion margins to enable post-injection safety monitoring
- Informed consent for this protocol must be provided and documented (i.e., signed ICF)
- Able to participate in an elective surgical procedure to inject LCTOPC1 21 days or later following SCI
- 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
You may not qualify if…
- SCI due to penetrating trauma
- Traumatic anatomical transection, laceration, or inadequate decompression of the spinal cord based on prior surgery or MRI
- 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
- Subjects with a cavity structure that would preclude successful transplantation, as identified on MRI, which may include septations or irregularities in tissue structure
- Persons with syringomyelia, defined as those with progressively enlarging cysts on T2-weighted images associated with neurological decline
- Inability to communicate effectively with neurological examiner such that the validity of patient data could be compromised
- Organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
- Need for mechanical support of ventilation (ventilator, continuous positive airway pressure [CPAP], bi-level positive airway pressure [BiPAP]), excluding supplemental oxygen, at baseline
- 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
- Pregnant or nursing women
- Subjects with an implanted spinal cord stimulator (SCS), whether temporary or permanent.
Where it is running
- University of California, San Diego — La Jolla, California, United States (enrolling)
- Rancho Research Institue — Downey, California, United States
Full record on ClinicalTrials.gov
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