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

Conditions

• Traumatic Thoracic Acute Spinal Cord Injury

Eligibility Criteria

Sex

ALL

Age

16 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Neuro-Spinal Scaffold — DEVICE
  Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery

Study Details

This is an HDE probable benefit, open-label, non- randomized, single-arm, multicenter study to evaluate the safety and probable benefit of the poly(lactic-co-glycolic acid)-b-poly(L-lysine) Scaffold ("Scaffold") in subjects with thoracic AIS A traumatic spinal cord injury at neurological level of injury of T2-T12.

Key Dates

First listed

May 14, 2014

Start date

Oct 13, 2014

Status verified

Jan 2024

Primary completion

Nov 29, 2017

Completion

Dec 31, 2023

Study Design

Enrollment

20 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Neuro-Spinal Scaffold
  Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery

Primary Outcome Measure

Percentage of Patients With Improvement in AIS Grade of One or More Levels [ Time Frame: 6 months post-implantation ]

Locations (8)

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