InVivo Adds Sites to Neuro-Spinal Scaffold IDE Study

Cambridge, Mass.-based InVivo Therapeutics Holdings Corp. has added the fifth and sixth clinical sites to its ongoing IDE pilot study of its neuro-spinal scaffold in patients with acute spinal cord injury (SCI): the Oregon Health & Science University (OHSU) in Portland, Ore., and the University of Pittsburgh Medical Center (UPMC) Presbyterian in Pittsburgh, Pa.
CEO Mark Perrin said that the centers will open for enrollment of new patients after a three month observation period of first patient. The first patient was enrolled on Oct. 15 at Barrow Neurological Institute in Phoenix, Ariz.

OHSU is a research university and Oregon’s only public academic health center, seeing nearly one million patients every year. Ahmed Raslan, M.D., an assistant professor of neurological surgery at OHSU, will be the study’s principal investigator at that site. UPMC is the largest non-governmental employer in Pennsylvania (with more than 62,000 employees) and operates more than 20 academic, community, and specialty hospitals and 400 outpatient sites. David Okonkwo, M.D., Ph.D., is the director of neurotrauma and director of scoliosis and spinal deformity at UPMC Presbyterian and associate professor of neurological surgery and clinical director of the Brain Trauma Research Center at the University of Pittsburgh. He will be the study’s principal investigator at that site.

“We have been searching for decades for an option for patients with these challenging injuries,” Okonkwo said. “The InVivo study is a unique, never-before tried intervention for spinal cord injury. I’m excited to see if it will prove to be a new way of treating thoracic spinal cord injuries.”

This is InVivo’s first clinical study of its investigational degradable polymer neuro-spinal scaffold. The 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 scaffold in five subjects with acute thoracic spinal cord injury. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a humanitarian device exemption.