InVivo Therapeutics has initiated the first clinical trial evaluating its investigational device, a degradable polymer Neuro-Spinal Scaffold, for spinal cord injury (SCI) patients.
The biocompatible polymer-based device is intended to promote structural support for spinal cord regeneration, while improving functional recovery and prognosis after a traumatic SCI.
In animal studies, the Neuro-Spinal Scaffold promoted cell adhesion, neurite sprouting, the growth of remodeled spinal cord tissue containing myelinated axons, and improved motor function.
Currently, there is no effective treatment for paralysis caused by SCI.
The initial clinical site, The University of Arizona Medical Center in Tucson, Arizona, has received Institutional Review Board (IRB) approval and has carried out all necessary contracts with InVivo.
Two other sites have received IRB approval and will begin enrolment in the second quarter of this year.
Surgical training will occur upon receipt of the Neuro-Spinal Scaffold, allowing the site to then begin subject enrolment.
Dr Ali A Baaj assistant professor of surgery and director of the spinal neurosurgery programme at The University of Arizona Medical Center is the principal investigator.
Dr Baaj said spinal cord injury research is a priority for the team at the University of Arizona Spinal Neurosurgery programme.
"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," Dr Baaj said.
This first clinical study, which is approved by the US Food and Drug Administration (FDA), is a pilot trial designed to gather safety and effectiveness data in five patients with an acute thoracic spinal cord injury.
The company then plans to conduct a pivotal study to obtain FDA approval to begin commercialisation under a humanitarian device exemption (HDE).
According to the company estimates, the global market for treating acute complete SCI is more than $500m annually, and the chronic SCI market is in excess of $10bn.
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."