Acute Implantation of a Bioresorbable Polymer Scaffold in Patients With Complete Thoracic Spinal Cord Injury: 24-Month Follow-up From the INSPIRE Study.

Publication/Presentation Date

6-1-2022

Abstract

BACKGROUND: Based on 6-month data from the InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurological Recovery in Patients with Complete Thoracic Spinal Cord Injury (INSPIRE) study (NCT02138110), acute implantation of an investigational bioresorbable polymer device (Neuro-Spinal Scaffold [NSS]) appeared to be safe in patients with complete thoracic spinal cord injury (SCI) and was associated with an ASIA Impairment Scale (AIS) conversion rate that exceeded historical controls.

OBJECTIVE: To evaluate outcomes through 24 months postimplantation.

METHODS: INSPIRE was a prospective, open-label, multicenter, single-arm study. Eligible patients had traumatic nonpenetrating SCI with a visible contusion on MRI, AIS A classification, neurological level of injury at T2-T12, and requirement for open spine surgery ≤96 hours postinjury.

RESULTS: Nineteen patients underwent NSS implantation. Three patients had early death determined by investigators to be unrelated to the NSS or its implantation procedure. Seven of 16 evaluable patients (44%) had improvement of ≥1 AIS grade at 6 months (primary end point) to AIS B (n = 5) or AIS C (n = 2). Three patients with AIS B at 6 months had further neurological improvement to AIS C by 12 (n = 2) and 24 (n = 1) months, respectively; none have deteriorated per latest available follow-up. No unanticipated or serious adverse device effects were reported.

CONCLUSION: In this small group of patients with complete thoracic SCI, acute NSS implantation within the spinal cord appeared to be safe with no long-term neurological issues identified during the 24-month follow-up. Patients remain stable, with additional AIS conversions observed in some patients at 12 months and beyond. These data further support the safety and probable benefit of NSS implantation in this patient population.

Volume

90

Issue

6

First Page

668

Last Page

675

ISSN

1524-4040

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

35442254

Department(s)

Administration and Leadership

Document Type

Article

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