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

Kee D. Kim, K. Stuart Lee, Domagoj Coric, James S. Harrop, Nicholas Theodore, Richard M. Toselli

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)668 and 675
JournalNeurosurgery
Volume90
Issue number6
DOIs
StatePublished - Jun 1 2022

Keywords

  • Absorbable implants
  • Biopolymers
  • Clinical trial
  • Spinal cord contusion
  • Spinal cord injuries
  • Spinal cord regeneration
  • Tissue scaffolding

ASJC Scopus subject areas

  • Clinical Neurology
  • Surgery

Fingerprint

Dive into the research topics of 'Acute Implantation of a Bioresorbable Polymer Scaffold in Patients With Complete Thoracic Spinal Cord Injury: 24-Month Follow-up From the INSPIRE Study'. Together they form a unique fingerprint.

Cite this