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

March 15, 2018 updated by: InVivo Therapeutics

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuro-Spinal Scaffold
Device: Neuro-Spinal Scaffold
Experimental: Neuro-Spinal Scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of all Adverse Device Effects of any kind/seriousness.
Time Frame: 6 Months
6 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
Improvements in motor and sensory scores
Time Frame: 6 months
ISNCSCI exams
6 months
Improvements in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Time Frame: 6 months
GRASSP Assessment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InVivo Therapeutics

Investigators

  • Study Director: Richard Toselli, MD, InVivo Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2017

Primary Completion (Actual)

March 15, 2018

Study Completion (Actual)

March 15, 2018

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

April 3, 2017

First Posted (Actual)

April 10, 2017

Study Record Updates

Last Update Posted (Actual)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 15, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InVivo-100-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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