The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold(TM) for Safety and Neurologic Recovery in Subjects With Complete Thoracic AIS A Spinal Cord Injury
This is an HDE probable benefit, open-label, non- randomized, single-arm, multicenter study to evaluate the safety and probable benefit of the poly(lactic-co-glycolic acid)-b-poly(L-lysine) Scaffold (Scaffold) in subjects with thoracic AIS A traumatic spinal cord injury at neurological level of injury of T2-T12.
⁃ Subjects must meet all of the following to be considered eligible:
• AIS A classification of traumatic spinal cord injury at T2-T12 neurological level of injury confirmed by a qualified medical professional
• Recent injury (must receive Scaffold within 7 days from injury)
• Non-penetrating SCI (contusion injury) that is no less than approximately 4 mm in diameter by MRI
• Requires open spine surgery allowing access to the injured spinal cord (subjects requiring either posterior surgical approach or posterior plus anterior approach will be eligible)
• Informed consent obtained
• 16-70 years of age, inclusive
• Hemodynamically stable and deemed a suitable candidate for surgery