InVivo Therapeutics Given Go-Ahead to Expedite Enrollment in Neuro-Spinal Scaffold Trial
The FDA has given a green light to expedited enrollment in InVivo Therapeutics’ ongoing clinical trial of the Neuro-Spinal Scaffold in patients with acute spinal cord injury, the company said Tuesday. The five-subject pilot study will capture preliminary safety and efficacy data in support of a larger pivotal study and humanitarian device exemption submission.
Under the revised IDE, InVivo will submit two months of safety data to the FDA for the first subject, who was enrolled in October, and then open enrollment for the second subject in mid-January. Following the submission of one-month safety data on that patient and the first patient’s data, the three remaining subjects will be enrolled.
According to the Cambridge, Mass., devicemaker, there will be no additional mandatory holds between enrollments of the final three subjects; the original plan required a three-month hold between each one.
The new plan could reduce the length of the trial by up to one year, says CEO Mark Perrin. The company hopes to complete enrollment in the coming year.
InVivo claims that its biodegradable Neuro-Spinal Scaffold — implanted in at the site of an acute spinal cord injury — spares spinal cord tissue, decreases post-traumatic cyst formation and lowers spinal cord tissue pressure. — Kellen Owings
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