InVivo Therapeutics reported an update on its INSPIRE study, testing the Neuro-Spinal Scaffold's safety and efficacy for patients with complete thoracic AIS A spinal cord injury.
Here are four things to know about the study:
1. InVivo notes a patient improved from complete AIS A SCI to motor incomplete AIS C SCI, when examined at the one-month visit.
2. At the six-month visit, another patient improved from complete AIS A SCI to sensory incomplete AIS B SCI.
3. At the six-month primary endpoint visit, six of the 11 patients showed an AIS grade improvement.
4. So far, researchers have reported seven conversions, four of which are AIS C conversions. These four patients have recovered sensory and motor functions.
Additionally, the company is temporarily halting patient enrollment in the INSPIRE study, following a patient death. The most recent patient implanted with the Neuro-Spinal Scaffold in late June died at a rehabilitation facility after discharge from the hospital. The site's principal investigator reported the cause of death was not related to the Neuro-Spinal Scaffold or implantation procedure.
The INSPIRE study has now seen three patient deaths, all of which were said to be unrelated to the Neuro-Spinal Scaffold or implantation procedure.
InVivo has decided to halt enrollment for the time being while working with the FDA to see if they should alter any patient enrollment criteria for those who have a higher mortality risk. The company plans to complete enrollment in the first half of 2018 and submit a Humanitarian Device Exemption application in the latter half of the year.