InVivo Therapeutics hasannounced that it has begun shipment of its investigational device, a degradable polymer Neuro-Spinal Scaffold for spinal cord injury patients, for initiation of the company’s first clinical trial.
According to InVivo, the new treatment platform utilises 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 remodelled spinal cord tissue containing myelinated axons, and improved motor function, it says in a company press release.
This clinical study, which is approved by the US 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 expects to conduct a pivotal study to obtain FDA approval to commence commercialisation under a Humanitarian Device Exemption (HDE).
The initial clinical site, The University of Arizona Medical Center in Tucson, USA, has reportedly received Institutional Review Board (IRB) approval and has executed all necessary contracts with InVivo. Surgical training is expected to occur upon receipt of the Neuro-Spinal Scaffold, allowing the site to then begin subject enrolment. Ali A Baaj, assistant professor of Surgery and Director of the Spinal Neurosurgery Program at The University of Arizona Medical Center is the principal Investigator. Commenting on the trial, Baaj says: “Spinal cord injury research is a priority for us 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.”
InVivo has received IRB approval from two additional sites and expects these two sites to be open for enrolment 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 says. “I anticipate continued momentum as additional sites are initiated in this important study.”