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

Primary Purpose

Traumatic Cervical Acute Spinal Cord Injury

Status

Withdrawn

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Neuro-Spinal Scaffold

About this trial

This is an interventional device feasibility trial for Traumatic Cervical Acute Spinal Cord Injury focused on measuring Spinal Cord Injury, SCI, Complete (AIS A) Traumatic Acute Spinal Cord Injury

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Toronto Western Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neuro-Spinal Scaffold

Arm Description

Outcomes

Primary Outcome Measures

Incidence of all Adverse Device Effects of any kind/seriousness.

Secondary Outcome Measures

Full Information

NCT ID

NCT03105882

First Posted

March 29, 2017

Last Updated

March 15, 2018

Sponsor

InVivo Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT03105882

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Study did not enroll any subjects.

Study Start Date

March 30, 2017 (Actual)

Primary Completion Date

March 15, 2018 (Actual)

Study Completion Date

March 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InVivo Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Cervical Acute Spinal Cord Injury

Keywords

Spinal Cord Injury, SCI, Complete (AIS A) Traumatic Acute Spinal Cord Injury

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Neuro-Spinal Scaffold

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Neuro-Spinal Scaffold

Intervention Description

Experimental: Neuro-Spinal Scaffold

Primary Outcome Measure Information:

Title

Incidence of all Adverse Device Effects of any kind/seriousness.

Time Frame

6 Months

Other Pre-specified Outcome Measures:

Title

American Spinal Injury Association Impairment Scale (AIS) improvement of one or more grade

Description

International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Exams

Time Frame

6 months

Title

Improvements in motor and sensory scores

Description

ISNCSCI exams

Time Frame

6 months

Title

Improvements in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)

Description

GRASSP Assessment

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Toselli, MD

Organizational Affiliation

InVivo Therapeutics

Official's Role

Study Director

Facility Information:

Facility Name

Toronto Western Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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