InVivo Therapeutics has announced that Froedtert & the Medical College of Wisconsin (MCW), Milwaukee, USA, has been added as a clinical site in the company’s ongoing investigational device exemption pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury.
Froedtert Hospital houses the only adult Level 1 trauma centre in eastern Wisconsin and receives referred spinal cord injury patients from Wisconsin, northern Illinois, and northern Michigan. Shekar Kurpad, professor of neurosurgery at MCW and director of the Spinal Cord Injury Center and Spine Surgery Fellowship at Froedtert Hospital, has been named principal investigator at the site.
“We are very excited to be a participant in this innovative and important, first-of-its-kind study,” Kurpad said.
In January 2015, InVivo announced enrolment of its second patient in the study at its clinical site, Carolinas Medical Center in Charlotte, USA. InVivo’s first patient was enrolled in October 2014 at the Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center in Phoenix, USA.
Mark Perrin, InVivo’s chief executive officer, said, “Shekar Kurpad has extensive experience in spinal cord injury research and was the recipient of the prestigious Van Wagenen fellowship from the American Association of Neurological Surgeons. We now have seven sites that will be ready to enrol patients once we re-open enrolment.”
This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The investigational device exemption pilot study has been approved by the US Food and Drug Administration (FDA) and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialisation under a Humanitarian Device Exemption.