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.
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. The study will be conducted by qualified Investigators who have been trained on the surgical Scaffold implant procedure in order to enroll subjects in the Primary Endpoint Analysis Set, defined as all subjects with a successful Scaffold implant, no major protocol deviations, and a complete 6-month Primary Endpoint Follow-up Visit. After receiving the Scaffold and following discharge, subjects will participate in a comprehensive rehabilitation program. For the first 24-months after implantation of the Scaffold, Follow-up and Long-term Follow-up assessments will be conducted at either the study site or the rehabilitation center. The Long-term Follow-up annual visits for years 3 through 10 will be conducted over the telephone.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
Barrow Neurological Institute - St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
USC/Keck School of Medicine
Los Angeles, California, United States
University of California/Davis Medical Center
Sacramento, California, United States
Percentage of Patients With Improvement in AIS Grade of One or More Levels
The ASIA (American Spinal Injury Association) Impairment Scale (AIS) classifies spinal cord injuries as follows: A = Complete: no sensory or motor function is preserved in the sacral segments S4-S5 B = Sensory incomplete: sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5, AND no motor function is preserved more than three levels below the motor level on either side of the body C = Motor incomplete: motor function is preserved below the neurological level, and more than half of key muscle functions below the single neurological level of injury have a muscle grade less than 3 (Grades 0-2) D = Motor incomplete: at least half (half or more) of key muscle functions below the NLI have a muscle grade \>3 E = Normal The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.
Time frame: 6 months post-implantation
Number of Participants Stratified by Change From Baseline in Neurological Level of Injury (NLI) at 6 Months
The neurological level of injury (NLI) refers to the most caudal segment of the spinal cord with normal sensory and antigravity motor function on both sides of the body, provided that there is normal (intact) sensory and motor function rostrally. A caudal change is an improvement in NLI whereas a rostral change is a deterioration in NLI. The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.
Time frame: 6 months post-implantation
Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Pin Prick Score
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Pin Prick Scores were assessed on a scale from 0 to 2 for each sensory point tested on each side of the body (maximum score = 112), with higher scores indicating better neurologic function. The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit. An improvement in pin prick score indicates an increase in score from baseline at 6-months A deterioration in pin prick score indicates a decrease in score from baseline at 6-months No change in pin prick score indicates no change in score from baseline at 6-months
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Cooper Neurological Institute
Camden, New Jersey, United States
Carolina NeuroSurgery and Spine Associates/Carolinas Rehabilitation
Charlotte, North Carolina, United States
Vidant Medical Center
Greenville, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Time frame: 6 months post-implantation
Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Light Touch Score
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Light Touch Scores were assessed on a scale from 0 to 2 for each sensory point tested on each side of the body (maximum score = 112), with higher scores indicating better neurologic function. The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit. An improvement in light touch score indicates an increase in light touch score from baseline at 6-months A deterioration in light touch score indicates a decrease in light touch score from baseline at 6-months No change in light touch score indicates no change in light touch score from baseline at 6-months
Time frame: 6 months post-implantation
Change From Baseline in ISNCSCI Total Motor Score
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Total Motor Scores were assessed on a scale from 0 to 5 for each myotome tested on each side of the body (upper limb maximum score = 50 and lower limb maximum score = 50), with higher scores indicating better neurologic function. The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit. An improvement in motor score indicates an increase in motor score from baseline at 6-months A deterioration in motor score indicates an decrease in motor score from baseline at 6-months No change in motor score indicates no change in motor score from baseline at 6-months
Time frame: 6 months post-implantation
Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Cyst (Presence or Absence)
Characteristics of spinal cord anatomy were assessed by a Board-certified neuroradiologist central reader including presence or absence of intraparenchymal cysts. Screening MRI was used as the baseline value.
Time frame: 6 months post-implantation
Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Spinal Cord Adhesion (Presence or Absence)
Characteristics of spinal cord anatomy were assessed by a Board-certified neuroradiologist central reader including the presence or absence of spinal cord adhesion. Screening MRI was used as the baseline value.
Time frame: 6 months post-implantation