1227 Acute Implantation of a Bioresorbable Polymer Scaffold for Complete Thoracic Spinal Cord Injury: A Randomized Trial (INSPIRE 2.0)

INTRODUCTION: No proven effective treatment options exist for traumatic spinal cord injury (SCI). In a prior single-arm study of patients with thoracic complete SCI (ClinicalTrials.gov, NCT02138110), acute implantation of an investigational bioresorbable polymer scaffold (Neuro-Spinal Scaffold [NSS]) appeared to be safe through 24 months postimplantation and was associated with a 6-month ASIA Impairment Scale (AIS) conversion rate (44%; 7/16 evaluable patients) that exceeded historical controls. METHODS: This randomized multicenter study was conducted at Level I trauma centers in the US (ClinicalTrials.gov, NCT03762655; funded by InVivo Therapeutics Corporation). Patients with AIS grade A, thoracic (T2-T12), non-penetrating SCI requiring spine surgery within 7 days post-injury were randomized (1:1, computer-generated allocation) to undergo NSS implantation during spine surgery (NSS group) or spine surgery alone (Comparator group). Patients and follow-up ISNCSCI assessors were blinded. Study success was defined a priori as a =20% higher proportion of patients with improvement in AIS grade at 6 months post-surgery (primary endpoint) in the NSS group than in the Comparator group. RESULTS: Target enrollment was reached (N=20); 10 randomized patients were analyzed in each treatment group. At 6 months post-surgery, an improvement in AIS grade was reported in 2 NSS patients (20%; both to AIS C) and 3 Comparator patients (30%; to AIS B [n=2] or AIS C [n=1]. No serious or unanticipated adverse device effects were reported. The study was closed due to not meeting its primary endpoint. CONCLUSIONS: Implantation of an intraparenchymal bioresorbable polymer scaffold did not produce probable clinical benefit in this small group. However, this study facilitates future advances in SCI treatment by providing further evidence that intraparenchymal surgery may be performed acutely and safely in complete SCI patients.