InVivo Therapeutics Holdings announced that Allegheny General Hospital (AGH) in Pittsburgh, part of Allegheny Health Network, has been added as a clinical site for The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury.
Surgeries will be performed at AGH, which treats more than 24,000 inpatients each year. AGH was the first hospital in the region to receive designation as a Level I Shock Trauma Center, which is the highest designation available.
“My research interests lie at the intersection of neuro-oncology and spinal disorders. While we routinely enter the spinal cord to remove tumors, the INSPIRE study is the first opportunity that affords us the ability to enter the spinal cord in trauma cases.
I look forward to being a part of this study, which has the potential to change the standard of care,” said Terrence Julien, M.D., System Director of Surgical Neuro-Oncology, System Co-Director of Minimally Invasive Spine Surgery, and Principal Investigator at the study site.
Mark Perrin, InVivo’s CEO and Chairman, said, “We are pleased to welcome Dr. Julien and his team at Allegheny General Hospital to the INSPIRE study. We continue to add quality sites like AGH and look forward to adding more in the near future.”
There are now 26 clinical sites participating in the clinical study:
Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter.
The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.