Study of Probable Benefit of the Neuro-Spinal Scaffold™ in Subjects With Complete Thoracic AIS A … (NCT03762655) | Clinical Trial Compass
TerminatedNot Applicable
Study of Probable Benefit of the Neuro-Spinal Scaffoldâ„¢ in Subjects With Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard of Care
Stopped: Primary Endpoint not met
United States20 participantsStarted 2019-05-21
Plain-language summary
This is a randomized, controlled, single-blind, multicenter, two Arm (Treatment or "Scaffold" Arm; Standard of Care or "Comparator" Arm) of a Neuro-Spinal Scaffold to evaluate whether the Scaffold is safe and demonstrates probable benefit for the treatment of complete T2-T12 spinal cord injury as compared to standard of care open spine surgery.
Who can participate
Age range16 Years – 70 Years
SexALL
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Inclusion criteria
✓. AIS A classification of traumatic spinal cord injury at T2 - T12 neurological level of injury confirmed by a qualified medical professional
✓. Recent injury (must have open spine surgery within 7 days from injury)
✓. Injury Severity Score (ISS) ≤ 45 at the time of screening
✓. Glasgow Coma Scale, GCS ≥ 14 (GCS ≥ 10 for intubated subjects) at the time of the screening and GCS = 15 (GCS ≥ 10 for intubated subjects) within two hours prior to spine surgery
✓. 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
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)
✕. Subjects with more than one discrete spinal cord injury
✕. No discrete cavity in the contused spinal cord in which a Scaffold can be placed
✕. Evidence of clear and significant Somatosensory Evoked Potentials (SSEP) transmission through the injury site (based on the judgment of the Investigator)
✕. Subjects with clinically significant pre-existing neurological comorbidities that are unrelated to the contusion being treated (e.g. MS, ALS, significant prior peripheral nerve dysfunction, residual problems related to previous spine-related neurological pathologies) will be excluded only if it is felt that these preexisting morbidities will increase risk, affect safety monitoring, or confound study results
✕. Spinal cord injury associated with significant traumatic brain injury or coma that, in the opinion of the Investigator, would preclude adequate assessment of spinal cord function, brain injury that could be associated on its own with sensory or motor deficits, or subjects with any other reason that results in an unreliable ISNCSCI exam
✕. Subjects with clinically significant pre-existing respiratory disease not related to the contusion being treated (e.g., COPD)