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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 April 2016 by InVivo Therapeutics
Sponsor:
Information provided by (Responsible Party):
InVivo Therapeutics
ClinicalTrials.gov Identifier:
NCT02138110
First received: May 1, 2014
Last updated: April 29, 2016
Last verified: April 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

Locations
United States, Arizona
Barrow Neurological Institute - St. Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Jill Danielson, RN, MS    602-406-6335    Jill.Danielson@DignityHealth.org   
Principal Investigator: Nicholas Theodore, MD         
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Gustavo Durazo, RN    520-626-8112    gustavodurazo@email.arizona.edu   
Principal Investigator: Travis Dumont, MD         
United States, California
USC/Keck School of Medicine Recruiting
Los Angeles, California, United States, 90033
Contact: Anush Arakelyan    323-442-7544    Anush.Arakelyan@med.usc.edu   
Principal Investigator: Patrick Hsieh, MD         
University of California/Davis Medical Center Recruiting
Sacramento, California, United States, 95816
Contact: Nancy Rudisill    916-734-3660    nancy.rudisill@ucdmc.ucdavis.edu   
Principal Investigator: Kee Kim, MD         
University of California San Diego Health System Recruiting
San Diego, California, United States, 92103
Contact: Nikki Sidhu    619-471-3698    nksidhu@ucsd.edu   
Principal Investigator: Joseph Ciacci, MD         
United States, Indiana
GoodmanCampbell Brain and Spine / IU Health Neuroscience Center, Suite 5100 Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Betty Logan    317-962-9978    blogan@IUHealth.org   
Principal Investigator: Eric M Horn, MD, PhD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Linda Jianis    913-588-3252    ljianas@kumc.edu   
Principal Investigator: Paul Arnold, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Debra Williams, MBA, CCRP    502-540-3353    debra.williams@louisville.edu   
Principal Investigator: Maxwell Boakye, MD         
United States, Missouri
Barnes-Jewish Hospital at Washington University Medical Center Recruiting
St. Louis, Missouri, United States, 63110
Contact    314-362-3114      
Principal Investigator: Paul Santiago, MD         
United States, New Jersey
Cooper Neurological Institute Recruiting
Camden, New Jersey, United States, 08103
Contact: Andrew March    856-342-2460    March-Andrew@CooperHealth.edu   
Principal Investigator: Steven S. Yocom, D.O.         
Rutgers-New Jersey Medical School Recruiting
Newark, New Jersey, United States, 07103
Contact: Lorelei Pratt, PhD    973-972-4702    lpratt@njms.rutgers.edu   
Principal Investigator: Robert F. Heary, MD         
United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Ashley Friend    212-241-2376    ashley.friend@mountsinai.org   
Principal Investigator: Arthur L Jenkins III, MD FACS         
United States, North Carolina
Carolina NeuroSurgery and Spine Associates/Carolinas Rehabilitation Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Peggy Boltes    704-831-4006    peggy.boltes@cnsa.com   
Contact: Marybeth Whitney    704-355-1409    Marybeth.Whitney@carolinashealthcare.org   
Principal Investigator: Domagoj Coric, MD         
Principal Investigator: William Bockenek, MD         
Vidant Medical Center Recruiting
Greenville, North Carolina, United States, 27834
Contact: Kimberly Guillemette    252-847-5449    kguillem@vidanthealth.com   
Principal Investigator: Stuart Lee, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Jessica Williams    503-494-9546    nsg@ohsu.edu   
Principal Investigator: Ahmed Raslan, MD         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Michelle Orlando    215-503-5646    michelle.orlando@jefferson.edu   
Contact: Alberto Montano    215-955-2173    alberto.montano@Jefferson.edu   
Principal Investigator: James Harrop, MD         
University of Pittsburgh Medical Center - Presbyterian Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Janice Alicandro    412-864-2188    alicandroja@upmc.edu   
Principal Investigator: David Okonkwo Okonkwo, MD, PhD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Amy Warren    434-243-9508    alh3p@virginia.edu   
Principal Investigator: Christopher Shaffrey, MD         
United States, Wisconsin
Medical College of Wisconsin/Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Laura Wollenweber    414-805-5403    lauraw@mcw.edu   
Principal Investigator: Shekar Kurpad, MD, PhD         
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: April 29, 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 September 29, 2016