A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants Wit… (NCT06841770) | Clinical Trial Compass
RecruitingPhase 1
A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants With Spinal Cord Injury
United States10 participantsStarted 2025-06-30
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Frequency and Severity of Adverse Events Related to the Delivery Device or Injection Procedure Through 30 Days
Timeframe: One month after LCTOPC1 injection
Trial details
NCT IDNCT06841770
SponsorLineage Cell Therapeutics, Inc.
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-08-10
Contact for this trial
Reference Study ID Number: LCTOPC1-SCI-03 https://lineagecell.com/products-pipeline/opc1/
✕. 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