It’s been a troubled few years for Neuro-Spinal Scaffold™ company, InVivo Therapeutics Holdings Corp. as it has balanced diminishing reserves against painfully slow regulatory progress as originally dictated by the FDA. So the company must be delighted with good news from a 12-month post-implant update for the first study patient from the pilot trial.
Background
InVivo’s biodegradable Neuro-Spinal Scaffold is surgically implanted at the “epicenter” of the wound following an acute spinal cord injury. It is designed to act as a physical substrate for nerve sprouting, which is quite a claim, and one that has underpinned the FDA’s cautious approach to product approval, resulting in the original (now superceded) demand for sequential patient follow up.
Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. Next up then was the pilot study in humans, the first of which was implanted a year ago under the terms of the IDE and with its Humanitarian Use Device (HUD) designation.
The ongoing pilot trial of InVivo’s investigational Neuro-Spinal Scaffold™ in patients with complete acute spinal cord injury, has yielded some promising results from patient number one. In the time between the 6-month and 12-month post-injury assessments, the patient demonstrated improvement in the American Spinal Injury Association (ASIA) lower extremity motor score with an additional 8 points gained on this 50 point score. The patient demonstrated additional bilateral improvements in the motor function of hip flexors and knee extensors and for the first time bilateral contractions of the ankle dorsiflexors and ankle plantar flexors.
For comparison, a large natural history database shows that patients with similar level injuries (T10-T12) have an average increase of lower extremity motor scores between 6 and 12 months of fewer than 2 points.
Company comments
Mark Perrin, InVivo’s CEO and Chairman stated; “I am delighted that our first patient continued to experience significant motor improvement after the 6-month visit. It is particularly exciting that the patient is regaining motor function in the ankle region as this indicates recovery is occurring not only in muscles that demonstrated some early recovery, but also in new muscles further down the legs. We are all hoping for continued improvement for the patient in the future. It was a brave decision to volunteer to be the first person ever to receive our investigational product, and it has been rewarding to observe the patient’s steady improvement over the last year.”
Source: InVivo Therapeutics Holdings, Corp.
