Pilot Study of the Neuro-Spinal Scaffold for the Treatment of AIS A Cervical Acute SCI
Not Applicable
Withdrawn
- Conditions
- Traumatic Cervical Acute Spinal Cord Injury
- Registration Number
- NCT03105882
- Lead Sponsor
- InVivo Therapeutics
- Brief Summary
Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal ScaffoldTM for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5-T1 Neurological Levels The purpose of this study is to support an expansion to support marketing applications as well as future studies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 16-70 years of age, inclusive
- AIS A classification of traumatic spinal cord injury with a neurological level within C5-T1 inclusive
- Recent injury
- Non-penetrating SCI
Exclusion Criteria
- Terminally ill subjects not likely to be able to participate in follow-up
- Incomplete spinal cord injury (AIS B, C, D, and E injuries)
- No identifiable intra-spinal cavity following myelotomy/irrigation in the contused spinal cord in which a Scaffold can be placed
- Spinal cord injury associated with significant traumatic brain injury or coma that
- Radiographic or visual evidence of parenchymal dissociation or anatomic transection as determined by the Investigator where the contusion completely bridges a full cross-section of the spinal cord
- Subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Incidence of all Adverse Device Effects of any kind/seriousness. 6 Months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Toronto Western Hospital🇨🇦Toronto, Ontario, Canada