InVivo Therapeutics has reopened subject enrolment for the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury. To date, there have been no reported serious safety events with the study’s first subject, and InVivo has been cleared by the Data Safety Monitoring Board (DSMB) to move forward with the study.
As specified in the study protocol, the DSMB is a committee of independent clinical research experts charged with examining the safety data accumulated during the trial.
Mark Perrin, InVivo’s chief executive officer, said: “Since enrolling the first subject, we have increased the number of clinical sites from three to six, putting us in a much better position to enrol the second subject. Although we cannot predict when subjects will present, we anticipate enrolling our second subject more quickly than our first.”
Perrin continued: “As we have already announced, once the second subject is enrolled, the Food and Drug Administration (FDA) will require only 30 days of safety data for that subject, rather than 90 days, before reopening enrolment. Barring any significant safety issues, we anticipate reopening the study for concurrent enrolment of subjects three through five about two months after the second subject is enrolled. In parallel, we are taking full advantage of a previous FDA approval and are making significant progress to increase the number of participating clinical sites up to 20.”
This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The Investigational Device Exemption pilot study has been approved by the FDA and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialisation under a Humanitarian Device Exemption.