Neuro-Spinal Scaffold"! Implantation in Patients with Acute Traumatic Thoracic Complete Spinal Cord Injury: 24 Month Results From the INSPIRE Study

Abstract

Abstract INTRODUCTION The Neuro-Spinal Scaffold"! (NSS) is an investigational biodegradable device developed to facilitate spinal cord repair following intraparenchymal implantation within the injured spinal cord. An open-label, single-arm, multicenter clinical study was conducted to evaluate the safety and efficacy of the device in acute thoracic complete spinal cord injury (SCI). Here, we report on available 24-mo follow-up data. METHODS The INSPIRE Study (NCT02138110) enrolled patients with nonpenetrating, thoracic (T2-T12/L1) AIS A SCI within 96 h of injury. Safety and neurological outcomes were assessed. The primary endpoint was AIS conversion rate at 6 mo. The study included an Objective Performance Criterion (OPC) defined as at least 25% of patients demonstrating an AIS grade improvement at 6 mo, which was derived from a 16% natural history AIS conversion rate in the studied patient population.[1] RESULTS A total of 19 patients were implanted with the NSS. There were 3 deaths determined by investigators to be unrelated to the NSS or its implantation. A total of 8 patients have completed the 24-mo assessment visit, with additional follow-up ongoing. Seven of the sixteen patients who reached the 6-mo primary endpoint visit experienced an AIS grade improvement (43.8%; AIS B, n = 5; AIS C, n = 2). Three of the five patients who converted to AIS B experienced further improvement to AIS C at 12 (n = 2) and 24 mo (n = 1) postinjury. At last follow-up, none of the patients with AIS conversion had deteriorated and there were no unanticipated or serious adverse device effects related to the NSS or its implantation as determined by investigators. CONCLUSION The INSPIRE study is the first to clinically evaluate implantation of a scaffold as a treatment for acute SCI. This study describes the safety of the NSS and feasibility of implantation. The AIS conversion rate exceeds published natural history rates and the OPC. Available results at twenty-four months continue to support further clinical investigation.