Pilot Study of the Neuro-Spinal Scaffold for the Treatment of AIS A Cervical Acute SCI

Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal Scaffold for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5 - T1 Neurological Levels

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.

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