Back to resultsThe INSPIRE Study: Probable Benefit of the Neuro-Spinal Scaffold for Treatment of AIS A Thoracic Acute Spinal Cord Injury
Primary Purpose
Traumatic Thoracic Acute Spinal Cord Injury
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuro-Spinal Scaffold
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Thoracic Acute Spinal Cord Injury focused on measuring Spinal Cord Injury (SCI), Complete (AIS A) Traumatic Acute Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Subjects who meet any of the following will be excluded:
- 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 (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)
- Subjects requiring Long-term ongoing mechanical ventilation
- Subjects with documented immune deficiency disorders, including a known diagnosis of HIV infection/AIDS
- Recent (according to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV or DSM V criteria) history of abuse of narcotics or other significant substance abuse
- Significant injury complications where, in the view of the Investigator, participation in the study could further complicate subject care, limit study follow-up, or confound interpretation of safety or efficacy data.
A female who is:
- Pregnant, or planning to become pregnant within the next 12-months; or
- Breastfeeding; or
- A woman of child-bearing potential (defined as post menarche and biologically capable of becoming pregnant [i.e., not surgically sterile]) who is engaged in active heterosexual relations and is not willing to use a barrier or hormonal form of birth control for 12-months following Scaffold implantation (e.g., oral, injected, or implanted contraceptives)
- A male who is engaged in active heterosexual relations and is not willing to use birth control for 3-months following Scaffold implantation including sperm donation or banking
- Current or impending incarceration
- Complete spinal cord transection
- Subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds.
- Known hypersensitivity to poly(lactic-co-glycolic acid) (PLGA) or poly-L-lysine (PLL) (e.g., hypersensitivity to absorbable sutures containing PLGA)
- History of severe mental illness (according to DSM IV or V)
- Evidence of pre-trauma active local or systemic infection
- Participation in another interventional clinical trial for six months after Scaffold implantation
- Body mass index (BMI) over 39
- Having a medical condition (e.g., cardiovascular disease, life threatening injuries), or receiving medical treatment, or having any other reason that, in the judgment of the Investigator, precludes successful participation and follow-up for at least six months or confounds collection or interpretation of study safety, feasibility, or efficacy data
Sites / Locations
- Barrow Neurological Institute - St. Joseph's Hospital and Medical Center
- USC/Keck School of Medicine
- University of California/Davis Medical Center
- Cooper Neurological Institute
- Carolina NeuroSurgery and Spine Associates/Carolinas Rehabilitation
- Vidant Medical Center
- Oregon Health & Science University
- Allegheny General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neuro-Spinal Scaffold
Arm Description
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02138110
Brief Title
The INSPIRE Study: Probable Benefit of the Neuro-Spinal Scaffold for Treatment of AIS A Thoracic Acute Spinal Cord Injury
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 13, 2014 (Actual)
Primary Completion Date
November 29, 2017 (Actual)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InVivo Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Thoracic Acute Spinal Cord Injury
Keywords
Spinal Cord Injury (SCI), Complete (AIS A) Traumatic Acute Spinal Cord Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neuro-Spinal Scaffold
Arm Type
Experimental
Arm Description
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
Intervention Type
Device
Intervention Name(s)
Neuro-Spinal Scaffold
Intervention Description
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
Primary Outcome Measure Information:
Title
Percentage of Patients With Improvement in AIS Grade of One or More Levels
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants Stratified by Change From Baseline in Neurological Level of Injury (NLI) at 6 Months
Description
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
Title
Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Pin Prick Score
Description
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
Time Frame
6 months post-implantation
Title
Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Light Touch Score
Description
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
Title
Change From Baseline in ISNCSCI Total Motor Score
Description
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
Title
Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Cyst (Presence or Absence)
Description
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
Title
Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Spinal Cord Adhesion (Presence or Absence)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Subjects who meet any of the following will be excluded:
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 (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)
Subjects requiring Long-term ongoing mechanical ventilation
Subjects with documented immune deficiency disorders, including a known diagnosis of HIV infection/AIDS
Recent (according to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV or DSM V criteria) history of abuse of narcotics or other significant substance abuse
Significant injury complications where, in the view of the Investigator, participation in the study could further complicate subject care, limit study follow-up, or confound interpretation of safety or efficacy data.
A female who is:
Pregnant, or planning to become pregnant within the next 12-months; or
Breastfeeding; or
A woman of child-bearing potential (defined as post menarche and biologically capable of becoming pregnant [i.e., not surgically sterile]) who is engaged in active heterosexual relations and is not willing to use a barrier or hormonal form of birth control for 12-months following Scaffold implantation (e.g., oral, injected, or implanted contraceptives)
A male who is engaged in active heterosexual relations and is not willing to use birth control for 3-months following Scaffold implantation including sperm donation or banking
Current or impending incarceration
Complete spinal cord transection
Subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds.
Known hypersensitivity to poly(lactic-co-glycolic acid) (PLGA) or poly-L-lysine (PLL) (e.g., hypersensitivity to absorbable sutures containing PLGA)
History of severe mental illness (according to DSM IV or V)
Evidence of pre-trauma active local or systemic infection
Participation in another interventional clinical trial for six months after Scaffold implantation
Body mass index (BMI) over 39
Having a medical condition (e.g., cardiovascular disease, life threatening injuries), or receiving medical treatment, or having any other reason that, in the judgment of the Investigator, precludes successful participation and follow-up for at least six months or confounds collection or interpretation of study safety, feasibility, or efficacy data
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Toselli, MD
Organizational Affiliation
InVivo Therapeutics Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Barrow Neurological Institute - St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
USC/Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California/Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Cooper Neurological Institute
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Carolina NeuroSurgery and Spine Associates/Carolinas Rehabilitation
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Vidant Medical Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35442254
Citation
Kim KD, Lee KS, Coric D, Harrop JS, Theodore N, Toselli RM. Acute Implantation of a Bioresorbable Polymer Scaffold in Patients With Complete Thoracic Spinal Cord Injury: 24-Month Follow-up From the INSPIRE Study. Neurosurgery. 2022 Jun 1;90(6):668-675. doi: 10.1227/neu.0000000000001932. Epub 2022 Apr 22.
Results Reference
derived
PubMed Identifier
33545674
Citation
Kim KD, Lee KS, Coric D, Chang JJ, Harrop JS, Theodore N, Toselli RM. A study of probable benefit of a bioresorbable polymer scaffold for safety and neurological recovery in patients with complete thoracic spinal cord injury: 6-month results from the INSPIRE study. J Neurosurg Spine. 2021 Feb 5;34(5):808-817. doi: 10.3171/2020.8.SPINE191507.
Results Reference
derived
PubMed Identifier
27309344
Citation
Theodore N, Hlubek R, Danielson J, Neff K, Vaickus L, Ulich TR, Ropper AE. First Human Implantation of a Bioresorbable Polymer Scaffold for Acute Traumatic Spinal Cord Injury: A Clinical Pilot Study for Safety and Feasibility. Neurosurgery. 2016 Aug;79(2):E305-12. doi: 10.1227/NEU.0000000000001283.
Results Reference
derived
Learn more about this trial
The INSPIRE Study: Probable Benefit of the Neuro-Spinal Scaffold for Treatment of AIS A Thoracic Acute Spinal Cord Injury
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