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

InVivo Therapeutics1 site in 1 countryMarch 30, 2017

ConditionsTraumatic Cervical Acute Spinal Cord Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Traumatic Cervical Acute Spinal Cord Injury
Sponsor: InVivo Therapeutics
Locations: 1
Primary Endpoint: Incidence of all Adverse Device Effects of any kind/seriousness.
Status: Withdrawn
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 30, 2017

End Date

March 15, 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

InVivo Therapeutics

Responsible Party

Sponsor

Eligibility 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