The INSPIRE Study: Probable Benefit of the Neuro-Spinal Scaffold for Treatment of AIS A Thoracic … (NCT02138110) | Clinical Trial Compass
TerminatedNot Applicable
The INSPIRE Study: Probable Benefit of the Neuro-Spinal Scaffold for Treatment of AIS A Thoracic Acute Spinal Cord Injury
Stopped: Primary Endpoint not met in follow-up study (InVivo-100-105)
United States20 participantsStarted 2014-10-13
Plain-language summary
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.
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 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
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)
What they're measuring
1
Percentage of Patients With Improvement in AIS Grade of One or More Levels
. Subjects with more than one discrete spinal cord injury (contusion) will be excluded.
✕. No discrete cavity (existing or created by irrigation/myelotomy) 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 before Scaffold implantation (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., multiple sclerosis, amyotrophic lateral sclerosis, 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 International Standards of Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
✕. Subjects with clinically significant pre-existing respiratory disease not related to the contusion being treated (e.g., chronic obstructive pulmonary disorder)