Status:
RECRUITING
A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants With Spinal Cord Injury
Lead Sponsor:
Lineage Cell Therapeutics, Inc.
Conditions:
Spinal Cord Injury Cervical
Spinal Cord Injury Thoracic
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 desi...
Detailed 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 ...
Eligibility Criteria
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
- 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:
- 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.
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2037
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06841770
Start Date
June 30 2025
End Date
June 30 2037
Last Update
February 12 2026
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Rancho Research Institue
Downey, California, United States, 90242
2
University of California, San Diego
La Jolla, California, United States, 92037