InVivo Therapeutics Begins Clinical Trial for its Spinal Cord Injury Technology

InVivo Therapeutics Holdings Corp. has initiated a clinical trail of its degradable polymer Neuro-Spinal Scaffold for spinal cord injury (SCI) patients. The trial is the company’s first.

Cambridge, Mass.-based InVivo has developed a new treatment platform that uses a biocompatible polymer-based device that is intended to promote structural support for spinal cord regeneration while improving functional recovery and prognosis after a traumatic spinal cord injury.

In preclinical studies, the Neuro-Spinal Scaffold promoted cell adhesion, neurite sprouting, the growth of remodeled spinal cord tissue containing myelinated axons, and improved motor function, the company reports. There currently is no effective treatment for paralysis caused by SCI. The company estimates the worldwide market for treating acute complete SCI to be more than $500 million annually, and the chronic SCI market to be worth more than $10 billion.

This first clinical study, which is approved by the U.S. Food and Drug Administration (FDA), is a pilot trial to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. The company then expects to conduct a pivotal study to obtain FDA approval to sell the device under a humanitarian device exemption.

The initial clinical site, the University of Arizona Medical Center in Tucson, has received institutional review board (IRB) approval and has executed all necessary contracts with InVivo, company officials reported.

Surgical training will occur upon receipt of the Neuro-Spinal Scaffold, allowing the site to then begin subject enrollment. Ali A. Baaj, M.D., assistant professor of surgery and director of the Spinal Neurosurgery Program at the University of Arizona Medical Center, is the trial’s principal investigator.

“Spinal cord injury research is a priority for us at the University of Arizona Spinal Neurosurgery program,” Baai said. “We are excited to collaborate with InVivo Therapeutics on this groundbreaking clinical trial as we strive to help patients who are affected by this devastating condition.”
InVivo has received IRB approval from two additional sites and expects these two sites to be open for enrollment in the second quarter.

“The InVivo team has put forth a tremendous effort to bring this innovative product to the clinic,” InVivo CEO Mark Perrin said. “I anticipate continued momentum as additional sites are initiated in this important study. We are dedicated to patients whose lives have been forever changed by their traumatic injury. InVivo’s Neuro-Spinal Scaffold technology may again change their lives—this time for the better.”

InVivo, a publicly traded company, 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 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.