InVivo Adds Barrow Neurological Institute Site To Spinal Cord Injuries Trial
By Cyndi Root
InVivo Therapeutics announced in a press release that it has added a third clinical site to its study of patients with acute spinal cord injury (SCI). The Barrow Neurological Institute (BNI) at St. Joseph's Hospital and Medical Center in Phoenix, AZ is one of the largest neurosurgical centers in the world for neurosurgical training, research, and patient care. BNI conducts more neurosurgical procedures than any other facility in the U.S.
Nicholas Theodore, MD, Professor of Neurosurgery, Director of Neurosurgery Spine Program, and Director of Neurotrauma at BNI and the study’s principal investigator, said, “At present there are no effective therapies for the treatment of acute thoracic spinal cord injury.” InVivo CEO Mark Perrin, said, “We are delighted to include the Barrow Neurological Institute in this study.”
InVivo Clinical Sites
The University of Arizona Medical Center in Tucson, AZ is an approved site as is the Carolina Medical Center in Charlotte, NC. The Center for Research at BNI is part of a group of 40 hospitals and medical centers in Arizona, California, and Nevada. The group, Dignity Health, oversees approximately 1,000 clinical trials, which it supports with 16 internal Institutional Review Boards and an office that manages regulatory and compliance oversight. BNI has a number of disciplines in neuroscience, including brain tumors, epilepsy, multiple sclerosis, and strokes. BNI will conduct surgical training after receipt of the spinal scaffold product and begin enrolling patients.
InVivo’s Neuro-Spinal Scaffold
Dr. Theodore, lead investigator at BNI, stated that the preclinical studies of InVivo’s Neuro-Spinal Scaffold were promising in treating traumatic spinal cord injury, showing cell adhesion, neurite sprouting, remodeled spinal cord tissue, and improved motor function. InVivo is now conducting its first clinical study of the investigational degradable polymer.
In March 2014, InVivo announced that it had shipped its first biocompatible structural support for spinal cord regeneration that improves recovery after an SCI. The pilot study is approved by the Food and Drug Administration (FDA) and will study five subjects, capturing safety and effectiveness data.