A third patient has been enrolled in the pilot study of the InVivo Therapeutics Neuro-Spinal Scaffold for the treatment of complete traumatic spinal cord injury (SCI). As with the second patient we reported on back in January, the third acute spinal cord injury patient was operated on at the Carolinas Medical Center, part of the Carolinas HealthCare System in Charlotte, NC.
Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and is currently being studied in an Investigational Device Exemption (IDE) pilot study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.
This is the company’s first clinical study of InVivo’s investigational degradable polymer Neuro-Spinal Scaffold. The Investigational Device Exemption (IDE) pilot study has been approved by the 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. Following the pilot trial, the company expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).
Dr. Dom Coric, of the Carolina Neurosurgery and Spine Associates and Chief of Neurosurgery at Carolinas Medical Center, together with Dr. William Bockenek, Chief Medical Officer at Carolinas Rehabilitation, are Co-Principal Investigators at this site. Dr. Coric along with Dr. Mark Smith of the Carolina Neurosurgery and Spine Associates, performed the third-ever Neuro-Spinal Scaffold implantation into an acute spinal cord injury patient. The implantation took place about three and a half days after the injury.
Dr. Coric said, “The implantation procedure went smoothly and the patient is doing very well. It has been rewarding to be involved in this clinical study, and I look forward to following the patient’s progress.”
Mark Perrin, InVivo’s CEO and Chairman, said, “This third patient affords us the opportunity to further extend our experience with the Neuro-Spinal Scaffold and will provide us with additional data for the design of a future pivotal study.”
Source: Business Wire