The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal ScaffoldTM for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury
Primary Objective: To evaluate whether the Scaffold is safe and demonstrates probable benefit for the treatment of complete T2-T12/L1 spinal cord injury.
Regulatory Objective: This is a Humanitarian Device Exemption (HDE) Probable Benefit study to demonstrate safety and probable benefit in support of future studies and an HDE application with subsequent approval.
The investigational product (Neuro-Spinal ScaffoldTM or Scaffold) is a porous bioresorbable polymer scaffold comprised of a synthetic biomaterial, poly((lactic-co-glycolic acid)-co-poly-(L-lysine)) (PLGA-PLL). The Scaffold is cylindrical in shape and comes in 2 sizes, 2 mm diameter by 10 mm length and 3 mm diameter by 10 mm length. The Scaffold is designed for optimal fit in the intra-spinal contusion cavity and can be trimmed if necessary to a specific length.
Duration of treatment/study:
Primary Endpoint: 6 months post-Scaffold implantation
Long-Term Follow-up Period: 6 months through 10 years post-Scaffold implantation (12 month and 24 month in-clinic visits, and annual phone follow-up through 10 years post-Scaffold implantation)
Criteria for evaluation:
Subjects with recent (<= 96 hours) T3 T12/L1 (neurologic spinal cord level) spinal cord injury (SCI) will be screened for participation.
General safety assessments:
Incidence of all safety events (AEs/ADEs) of any kind/seriousness; Incidence of all serious safety events (SAEs/SADEs); Incidence of unanticipated ADEs (UADEs)
Primary Efficacy Endpoint
Proportion of subjects with improvement in AIS grade of one or more levels
Secondary Efficacy Endpoints
1. Proportion of subjects with improvement in sensory scores
2. Proportion of subjects with improvement in motor scores
3. Proportion of subjects with improvement in hip abduction, hip adduction
or great toe flexion/extension
4. Proportion of subjects with improvement in bowel function
5. Proportion of subjects with improvement in bladder function
6. Proportion of subjects with decreased pain
7. Proportion of subjects with improvement in SCIM III
8. Proportion of subjects with improvement in QLI-SCI III
The primary analysis (safety and efficacy) of the study will employ data up to and including the 6 Month Primary Endpoint Follow-up Visit (6 months post- Scaffold implantation). Additional Long-Term Follow-up analyses will be performed for information obtained after the 6 Month Primary Endpoint Follow-up Visit.
The results will be presented primarily via data tabulation and listed by subject ID and time course because this is an HDE Probable Benefit study with a small sample size. Group descriptive statistics and cumulative statistics will be utilized if appropriate. Data from subjects enrolled prior to Amendment 9 and subjects < 22 years old (i.e., pediatric population) will be clearly identified in the data tabulations.