Phase
Condition
Limb Spasticity
Spinal Cord Disorders
Spinal Cord Injuries
Treatment
OPC1
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) or sensoryincomplete, traumatic SCI (ASIA Impairment Scale B)
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
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
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 andlesion margins to enable post-injection safety monitoring
Informed consent for this protocol must be provided and documented (i.e., signedICF)
Able to participate in an elective surgical procedure to inject LCTOPC1 21 days orlater following SCI
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:
SCI due to penetrating trauma
Traumatic anatomical transection, laceration, or inadequate decompression of thespinal cord based on prior surgery or MRI
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
Subjects with a cavity structure that would preclude successful transplantation, asidentified on MRI, which may include septations or irregularities in tissuestructure
Persons with syringomyelia, defined as those with progressively enlarging cysts onT2-weighted images associated with neurological decline
Inability to communicate effectively with neurological examiner such that thevalidity of patient data could be compromised
Organ damage or systemic disease that would create an unacceptable risk for surgeryor immunosuppression
Need for mechanical support of ventilation (ventilator, continuous positive airwaypressure [CPAP], bi-level positive airway pressure [BiPAP]), excluding supplementaloxygen, at baseline
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
Pregnant or nursing women
Subjects with an implanted spinal cord stimulator (SCS), whether temporary orpermanent.
Study Design
Study Description
Connect with a study center
University of California, San Diego
La Jolla, California 92037
United StatesSite Not Available
Rancho Research Institue
Downey 5343858, California 5332921 90242
United StatesSite Not Available
University of California, San Diego
La Jolla 5363943, California 5332921 92037
United StatesActive - Recruiting

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