A fourth patient has recently been enrolled in InVivo Therapeutics’ investigational trial of the Neuro-Spinal Scaffold for patients with acute thoracic spinal cord injury.
According to a media release from InVivo, the FDA-approved Investigational Device Exemption (IDE) study is intended to capture preliminary safety and effectiveness data for the Neuro-Spinal Scaffold in five patients with acute thoracic spinal cord injury.
The biodegradable Neuro-Spinal Scaffold is implanted in the epicenter of the spinal cord injury, and is designed to act as a physical substrate for nerve sprouting, the release explains.
The release notes that the study’s principal investigator, Kee Kim, MD, performed the Neuro-Spinal Scaffold implantation surgery—reportedly the fourth implantation surgery ever performed—at UC Davis Medical Center in Sacramento, Calif, approximately 53 hours after the patient experienced the initial spinal cord injury.
Mark Perrin, InVivo’s CEO and chairman, says in the release that meaningful progress in the clinical trial is continuing, adding that, “With the fourth patient successfully enrolled, we look forward to enrolling the fifth and final patient in our pilot study and preparing for our pivotal probable benefit study.”
For more information about the trial, visit clinicaltrials.gov/ct2/show/study/NCT02138110
[Source(s): InVivo Therapeutics, Business Wire]
