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Pilot Study of the Neuro-Spinal Scaffold for the Treatment of AIS A Cervical Acute SCI

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: NCT03105882
Recruitment Status : Withdrawn (Study did not enroll any subjects.)
First Posted : April 10, 2017
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
InVivo Therapeutics

Study Description
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Brief Summary:
Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal ScaffoldTM for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5-T1 Neurological Levels The purpose of this study is to support an expansion to support marketing applications as well as future studies.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal Scaffold for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5 - T1 Neurological Levels
Actual Study Start Date : March 30, 2017
Actual Primary Completion Date : March 15, 2018
Actual Study Completion Date : March 15, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Neuro-Spinal Scaffold Device: Neuro-Spinal Scaffold
Experimental: Neuro-Spinal Scaffold


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of all Adverse Device Effects of any kind/seriousness. [ Time Frame: 6 Months ]

Other Outcome Measures:
  1. American Spinal Injury Association Impairment Scale (AIS) improvement of one or more grade [ Time Frame: 6 months ]
    International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Exams

  2. Improvements in motor and sensory scores [ Time Frame: 6 months ]
    ISNCSCI exams

  3. Improvements in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) [ Time Frame: 6 months ]
    GRASSP Assessment


Eligibility Criteria
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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:

  • 16-70 years of age, inclusive
  • AIS A classification of traumatic spinal cord injury with a neurological level within C5-T1 inclusive
  • Recent injury
  • Non-penetrating SCI

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)
  • No identifiable intra-spinal cavity following myelotomy/irrigation in the contused spinal cord in which a Scaffold can be placed
  • Spinal cord injury associated with significant traumatic brain injury or coma that
  • Radiographic or visual evidence of parenchymal dissociation or anatomic transection as determined by the Investigator where the contusion completely bridges a full cross-section of the spinal cord
  • Subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds
Contacts and Locations
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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): NCT03105882


Locations
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Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
InVivo Therapeutics
Investigators
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Study Director: Richard Toselli, MD InVivo Therapeutics
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: InVivo Therapeutics
ClinicalTrials.gov Identifier: NCT03105882    
Other Study ID Numbers: InVivo-100-102
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

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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:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System