The potential benefits of a novel bioresorbable polymer scaffold in patients with complete thoracic spinal cord injury outweigh the risks, but further clinical investigation as part of a randomised controlled trial is needed, according to the authors of the INSPIRE study, who have released six-month findings from the trial.
This first-in-human study, the findings of which were published in the Journal of Neurosurgery by Kee D. Kim (UC Davis Medical Center, Sacramento, USA) et al, sought to evaluate whether the investigational Neuro-Spinal Scaffold (NSS; InVivo Therapeutics), a highly porous bioresorbable polymer device, demonstrates probable benefit for safety and neurological recovery in patients with complete (AIS grade A) T2–12 spinal cord injury (SCI) when implanted less than 96 hours’ post-injury.
The NSS was implanted into the epicentre of the postirrigation intramedullary spinal cord contusion cavity with the intention of providing structural support to the injured spinal cord parenchyma.
The primary efficacy endpoint was the proportion of patients who had an improvement of one or more AIS grade at six-month follow-up.
A total of 19 patients underwent NSS implantation. There were three early withdrawals due to death, which were all determined by investigators to be unrelated to the NSS or the implantation procedure.
Seven of the remaining 16 patients (43.8%) who completed the six-month follow-up visit had conversion of neurological status (AIS grade A to grade B [n = 5] or C [n = 2]). There were no unanticipated or serious adverse device effects or serious adverse events related to the NSS or the implantation procedure as determined by investigators.
Writing in the Journal of Neurosurgery, Kim et al said: “Implantation of the NSS within the spinal cord appeared to be safe in the setting of surgical decompression and stabilisation for complete (AIS grade A) thoracic SCI. It was associated with a six-month AIS grade conversion rate that exceeded historical controls.
“The INSPIRE study data demonstrate that the potential benefits of the NSS outweigh the risks in this patient population and support further clinical investigation in a randomised controlled trial.”
Speaking to Spinal News International, Kim added: “AIS conversion rate for this study exceeded historical benchmarks of about 16% to 21% for patients with complete thoracic spinal cord injury. Longer follow-up showed that some of the responders improved further in AIS grade and our 24-month follow-up paper is submitted for publication.
“The results are promising because even with advances, there are no new effective treatments for this devastating injury. A multicentre randomised study is currently underway to compare the results between the Neuro-Spinal Scaffold implantation and standard-of-care treatment.”