A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants With Spinal Cord Injury

Korábbi kezelés

• 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
• 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

Más betegség

• Organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression

Egyéb

• SCI due to penetrating trauma
• 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
• Need for mechanical support of ventilation (ventilator, continuous positive airway pressure [CPAP], bi-level positive airway pressure [BiPAP]), excluding supplemental oxygen, at baseline
• Pregnant or nursing women
• Subjects with an implanted spinal cord stimulator (SCS), whether temporary or permanent.

• 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