InVivo Therapeutics released the 12-month results of its investigational study of the Neuro-Spinal Scaffold to treat acute thoracic complete spinal cord injury.
Here are five things to know:
1. In the INSPIRE study, seven of the 16 patients — 44 percent — who reached the six-month primary endpoint visit had an ASIA Impairment Scale conversion at six months after implantation. The objective performance criterion for the study was a 25 percent AIS conversion rate based on the published conversion rates for thoracic SCI.
2. All patients evaluated at the 12-month follow-up mark who had converted an AIS grade at the sixth-month visit remained converted.
3. In total, 19 patients were implanted with the investigational Neuro-Spinal Scaffold in the INSPIRE study.
4. InVivo has officially closed the INSPIRE study and received FDA supplemental investigational device exemption approval for a second clinical study of the Neuro-Spinal Scaffold in patients with acute SCI. INSPIRE 2.0 will include 20 patients and is intended to enhance the existing clinical evidence.
5. The Neuro-Spinal Scaffold is a bioresorbable polymer scaffold designed for implantation at the site of injury within a spinal cord contusion. It is engineered to provide structural support to the spared spinal tissue and a supportive matrix to encourage endogenous repair processes. The scaffold degrades over several weeks.