RecruitingSpinal Cord Injury CervicalSpinal Cord Injury ThoracicSpinal Cord Injury, Acute
A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants With Spinal Cord Injury
Eligible age
18–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Lineage Cell Therapeutics, Inc.
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
California
Downey · La Jolla
Source: ClinicalTrials.gov · NCT06841770 · last updated 2026-02-12