InVivo Therapeuticshas announced that the Oregon Health & Science University (OHSU) in Portland, Oregon, USA, is the fifth clinical site in the company’s ongoing IDE pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). Ahmed Raslan, an assistant professor of neurological surgery at OHSU, will be the study’s principal investigator at that site.
“It is very exciting to be a part of this first-in-human trial for the Neuro-Spinal Scaffold,” Raslan comments. “This important contribution to science demonstrated promising results in pre-clinical studies and provides, for the first time, a categorically distinct form of potential repair after SCI.”
In October, InVivo announced enrolment of its first patient at Barrow Neurological Institute in Phoenix, Arizona, USA. Mark Perrin, InVivo chief executive officer, says: “We are delighted to have Ahmed Raslan and OHSU join us. OHSU and the other centres will be able to enrol the next subject following the three-month observation period for first patient.”
This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The IDE 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.