Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
Trial ID or NCT#
The purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).
A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury
- - Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) for cohorts 1,2,3
- - Sensorimotor incomplete, traumatic SCI (ASIA Impairment Scale B) for cohorts 4,5
- - Last fully preserved single neurological level (SNL) from C-4 to C-7
- - From 18 through 69 years of age at time of injury
- - Single spinal cord lesion on a post-stabilization magnetic resonance imaging (MRI) scan, with sufficient visualization of the spinal cord injury epicenter and lesion margins to enable post-injection safety monitoring
- - Informed consent for this protocol and the companion long term follow-up protocol must be provided and documented (i.e., signed informed consent forms) no later than 37 days following injury
- - Able to participate in an elective surgical procedure to inject AST-OPC1 21-42 days following SCI
- - SCI due to penetrating trauma
- - Traumatic anatomical transection or laceration of the spinal cord based on prior surgery or MRI
- - Any concomitant injury that interferes with the performance, interpretation or validity of neurological examinations
- - Inability to communicate effectively with neurological examiner such that the validity of patient data could be compromised
- - Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
- - History of any malignancy (except non-melanoma skin cancers)
- - Pregnant or nursing women
- - Body mass index (BMI) > 35 or weight > 300 lbs.
- - Active participation in another experimental procedure/intervention
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