InVivo Therapeutics has announced the reopening of subject enrolment for the company’s ongoing investigational device exemption pilot study of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury.
Barring significant safety issues, the final three subjects of this pilot trial will be enrolled concurrently and without mandatory safety hold between enrolment of each subject. To date, there have been no reported serious safety events related to the Neuro-Spinal Scaffold or the procedure to implant the Neuro-Spinal Scaffold with the study’s first and second subjects, and InVivo has been approved by Food and Drug Administration and the Data Safety Monitoring Board to move forward with the study.
Mark Perrin, InVivo’s chief executive officer and chairman, said, “Despite a severe, multi-trauma injury that included a collapsed lung and resulted in a two day delay in spinal stabilisation and Neuro-Spinal Scaffold implantation, the second subject has not experienced any serious safety events to date related to our investigational product. Although we cannot predict when subjects will present, we anticipate enrolling subjects three through five this calendar year, which would complete enrolment for the pilot trial. We can now enrol the final patients concurrently, and we now have eight active clinical sites that can participate in this trial.”