Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 13 for:    InVivo spinal cord injury
Previous Study | Return to List | Next Study

The INSPIRE Study: Probable Benefit of the Neuro-Spinal Scaffold for Treatment of AIS A Thoracic Acute Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02138110
Recruitment Status : Active, not recruiting
First Posted : May 14, 2014
Results First Posted : December 28, 2018
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
InVivo Therapeutics

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.

Condition or disease Intervention/treatment Phase
Traumatic Thoracic Acute Spinal Cord Injury Device: Neuro-Spinal Scaffold Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 13, 2014
Actual Primary Completion Date : November 29, 2017
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neuro-Spinal Scaffold
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
Device: Neuro-Spinal Scaffold
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery




Primary Outcome Measures :
  1. Percentage of Patients With Improvement in AIS Grade of One or More Levels [ Time Frame: 6 months post-implantation ]

    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 :
  1. Number of Participants Stratified by Change From Baseline in Neurological Level of Injury (NLI) at 6 Months [ Time Frame: 6 months post-implantation ]

    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.


  2. Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Pin Prick Score [ Time Frame: 6 months post-implantation ]

    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


  3. Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Light Touch Score [ Time Frame: 6 months post-implantation ]

    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


  4. Change From Baseline in ISNCSCI Total Motor Score [ Time Frame: 6 months post-implantation ]

    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


  5. Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Cyst (Presence or Absence) [ Time Frame: 6 months post-implantation ]

    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.


  6. Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Spinal Cord Adhesion (Presence or Absence) [ Time Frame: 6 months post-implantation ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet all of the following to be considered eligible:

  1. AIS A classification of traumatic spinal cord injury at T2-T12 neurological level of injury confirmed by a qualified medical professional
  2. Recent injury (must receive Scaffold within 7 days from injury)
  3. Non-penetrating SCI (contusion injury) that is no less than approximately 4 mm in diameter by MRI
  4. 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)
  5. Informed consent obtained
  6. 16-70 years of age, inclusive
  7. Hemodynamically stable and deemed a suitable candidate for surgery

Exclusion Criteria:

Subjects who meet any of the following will be excluded:

  1. Terminally ill subjects not likely to be able to participate in follow-up
  2. Incomplete spinal cord injury (AIS B, C, D, and E injuries)
  3. Subjects with more than one discrete spinal cord injury (contusion) will be excluded.
  4. No discrete cavity (existing or created by irrigation/myelotomy) in the contused spinal cord in which a Scaffold can be placed
  5. Evidence of clear and significant Somatosensory Evoked Potentials (SSEP) transmission through the injury site before Scaffold implantation (based on the judgment of the Investigator)
  6. 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
  7. 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
  8. Subjects with clinically significant pre-existing respiratory disease not related to the contusion being treated (e.g., chronic obstructive pulmonary disorder)
  9. Subjects requiring Long-term ongoing mechanical ventilation
  10. Subjects with documented immune deficiency disorders, including a known diagnosis of HIV infection/AIDS
  11. 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
  12. 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.
  13. 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)
  14. 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
  15. Current or impending incarceration
  16. Complete spinal cord transection
  17. Subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds.
  18. Known hypersensitivity to poly(lactic-co-glycolic acid) (PLGA) or poly-L-lysine (PLL) (e.g., hypersensitivity to absorbable sutures containing PLGA)
  19. History of severe mental illness (according to DSM IV or V)
  20. Evidence of pre-trauma active local or systemic infection
  21. Participation in another interventional clinical trial for six months after Scaffold implantation
  22. Body mass index (BMI) over 39
  23. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138110


Locations
Layout table for location information
United States, Arizona
Barrow Neurological Institute - St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
USC/Keck School of Medicine
Los Angeles, California, United States, 90033
University of California/Davis Medical Center
Sacramento, California, United States, 95816
United States, New Jersey
Cooper Neurological Institute
Camden, New Jersey, United States, 08103
United States, North Carolina
Carolina NeuroSurgery and Spine Associates/Carolinas Rehabilitation
Charlotte, North Carolina, United States, 28204
Vidant Medical Center
Greenville, North Carolina, United States, 27834
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
InVivo Therapeutics
Investigators
Layout table for investigator information
Study Director: Richard Toselli, MD InVivo Therapeutics Corporation
  Study Documents (Full-Text)

Documents provided by InVivo Therapeutics:
Statistical Analysis Plan  [PDF] January 17, 2018
Study Protocol  [PDF] June 29, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: InVivo Therapeutics
ClinicalTrials.gov Identifier: NCT02138110    
Other Study ID Numbers: InVivo-100-101
First Posted: May 14, 2014    Key Record Dates
Results First Posted: December 28, 2018
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by InVivo Therapeutics:
Spinal Cord Injury (SCI)
Complete (AIS A) Traumatic Acute Spinal Cord Injury
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System