InVivo Therapeutics Adds Clinical Site to Pilot Study

InVivo Therapeutics Holdings Corp. added Rutgers New Jersey Medical School in Newark, N.J., as a clinical site in the company’s ongoing pilot study of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI).

Robert Heary, M.D., professor of neurological surgery and director of the Spine Center, has been named principal investigator at this site. The Spine Center is part of the Northern New Jersey Spinal Cord Injury System, one of 14 federally designated spinal cord injury model systems in the United States and the only one in the state of New Jersey.

“We are delighted to join InVivo’s cutting-edge spinal cord injury trial,” Heary said. “Our integrated approach to spinal cord injury and our location in the nation’s largest metropolitan area make us an ideal candidate for this type of research.”

Mark Perrin, InVivo’s CEO and chairman, said: “We are pleased to welcome Dr. Heary and the New Jersey Medical School into InVivo’s ongoing pilot study. Having a Spinal Cord Injury Model System Center as part of our trial will be beneficial as we look to enroll the final two patients in our ongoing study.”

Including New Jersey, there are currently 12 clinical sites that are open for enrollment in Arizona (2), California (2), Indiana, Kansas, Missouri, North Carolina, Oregon, Pennsylvania and Wisconsin. 

This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The investigational device exemption (IDE) pilot study has been approved by the U.S. Food and Drug Administration (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. Following the pilot trial, InVivo expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a humanitarian device exemption. 

Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. 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.

InVivo Therapeutics was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly traded company is headquartered in Cambridge, Mass.