Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT02302157
Eligibility Criteria:
Major Inclusion Criteria:
* 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
Major Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT02302157
Study Brief:
Protocol Section:
NCT02302157