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:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT01217008
Eligibility Criteria:
Major Inclusion Criteria:
* Neurologically complete, traumatic SCI (ASIA Impairment Scale A), zone of partial preservation \< 5 levels
* Last fully preserved neurological level from T-3 through T-11
* From 18 through 65 years of age at time of injury
* Single spinal cord lesion
* 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 11 days following injury
* Able to participate in an elective surgical procedure to inject GRNOPC1 7-14 days following SCI
Major Exclusion Criteria:
* SCI due to penetrating trauma
* Traumatic anatomical transection or laceration of the spinal cord
* Any concomitant injury or pre-existing condition that interferes with the performance, interpretation or validity of neurological examinations
* Inability to communicate effectively with neurological examiner
* Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
* History of any malignancy
* 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:
65 Years
Study:
NCT01217008
Study Brief:
Protocol Section:
NCT01217008