InVivo Therapeutics Cleared to Enroll Second Patient in Spine Trial

InVivo Therapeutics has reopened patient enrollment in its ongoing pilot trial of the Neuro-Spinal Scaffold, following clearance from a data safety monitoring board. The green light followed a review of safety data submitted with a revised investigational device exemption protocol in December. 

No serious safety events were noted with the trial’s first subject, InVivo said Friday. The device is intended for patients with acute spinal cord injury.

Since enrolling the first patient, InVivo has increased the number of clinical sites from three to six, with plans to add as many as 14 more, CEO Mark Perrin said. This puts InVivo in a better position to enroll the second subject, he added.

Perrin anticipates the company enrolling subjects three through five roughly two months after the second patient is enrolled.

The biodegradable Neuro-Spinal Scaffold — implanted at the site of an acute spinal cord injury — is designed to spare spinal cord tissue, decrease posttraumatic cyst formation and lower spinal cord tissue pressure, according to InVivo. Once the pilot study is completed, the company plans to pursue commercialization via a humanitarian device exemption. — Kellen Owings