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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by InVivo Therapeutics
Sponsor:
Information provided by (Responsible Party):
InVivo Therapeutics
ClinicalTrials.gov Identifier:
NCT02138110
First received: May 1, 2014
Last updated: December 7, 2016
Last verified: December 2016
  Purpose
  • To evaluate whether the Scaffold is safe and demonstrates probable benefit for the treatment of complete T2-T12/L1 spinal cord injury .
  • This is a Humanitarian Device Exemption (HDE) Probable Benefit Study to demonstrate safety and probable benefit in support of future studies and an HDE application with subsequent approval.

Condition Intervention Phase
Traumatic Thoracic Acute Spinal Cord Injury
Device: Neuro-Spinal Scaffold
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by InVivo Therapeutics:

Primary Outcome Measures:
  • Proportion of subjects with improvement in AIS grade of one or more levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    A preset objective performance criterion (OPC) based upon this proportion will be used as the primary measure of success for this study.


Secondary Outcome Measures:
  • Proportion of subjects with improvement in motor scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of subjects with improvement in sensory scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of subjects with improvement in hip abduction/adduction or great toe flexion/extension [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of subjects with improvement in bowel function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of subjects with improvement in bladder function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of subjects with improvement in SCIM III [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of subjects with improvement in QLI-SCI III [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of subjects with decreased pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of all Adverse Device Effects of any kind/seriousness. [ Time Frame: 6 months ]

Estimated Enrollment: 20
Study Start Date: April 2014
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neuro-Spinal Scaffold Device: Neuro-Spinal Scaffold

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Aged 16 - 70 years
  • AIS A traumatic spinal cord injury at neurological spinal cord level T2-T12/L1
  • Recent injury (must receive Scaffold within 96 hours from injury)
  • Non-penetrating contusion injury no less than approximately 4 mm diameter by MRI

Key Exclusion Criteria:

  • Incomplete spinal cord injury (AIS B, C, D, E)
  • Terminally ill
  • Spinal cord injury associated with traumatic brain injury
  • Subject on long term mechanical ventilation
  • Penetrating injuries
  • Radiographic or visual evidence of parenchymal dissociation or anatomic transection where the contusion completely bridges a full cross-section of the spinal cord
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02138110

Contacts
Contact: Kristin Neff 617-863-5581 kneff@invivotherapeutics.com
Contact: Rebekah DeVitry 617-460-2820 rdevitry@invivotherapeutics.com

  Show 27 Study Locations
Sponsors and Collaborators
InVivo Therapeutics
Investigators
Study Director: Lorianne Masuoka, MD InVivo Therapeutics
  More Information

Responsible Party: InVivo Therapeutics
ClinicalTrials.gov Identifier: NCT02138110     History of Changes
Other Study ID Numbers: InVivo-100-101 
Study First Received: May 1, 2014
Last Updated: December 7, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by InVivo Therapeutics:
Spinal Cord Injury (SCI)
Complete (AIS A) Traumatic Acute Spinal Cord Injury

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on December 08, 2016