InVivo Reports Progress in Neuro-Spinal Scaffold Trial

Cambridge, Mass.-based InVivo Therapeutics Holdings Corp. has enrolled its second subject into the pilot study of its neuro-spinal scaffold for the treatment of complete traumatic spinal cord injury (SCI) at the Carolinas Medical Center, part of the Carolinas HealthCare System in Charlotte, N.C. The objective of the pilot study is to evaluate the safety and feasibility of the neuro-spinal scaffold as well as to gather preliminary evidence of effectiveness. The first subject was enrolled in October.

Domagoj Coric, M.D., chief of neurosurgery at Carolinas Medical Center, together with Dr. William Bockenek, M.D., chief medical officer of Carolinas Rehabilitation, are co-principal investigators at this site. Coric and his partner John Ziewacz, M.D., both of the Carolina Neurosurgery and Spine Associates, performed the second-ever Neuro-Spinal Scaffold implant into an acute spinal cord injury patient.

“This subject sustained a severe, multi-trauma injury that required my team to wait two days for the subject to stabilize medically before proceeding with the concurrent spinal stabilization and implantation surgery,” said Coric. “The implantation procedure was a success, and I look forward to monitoring the subject’s progress.”

“Although each accident that results in a spinal cord injury is tragic, we’re grateful to have enrolled the second subject so quickly after re-opening enrollment, and are looking forward to monitoring the subject’s progress,” said Mark Perrin, InVivo’s CEO. “As previously stated, the U.S. Food and Drug Administration (FDA) will require only 30 days of safety data for this subject, rather than the original requirement of 90 days, before reopening enrollment. Barring any significant safety issues, we anticipate reopening the study for concurrent enrollment of subjects three through five in about two months.”

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 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, InVivo expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a humanitarian device exemption.

The biodegradable neuro-spinal scaffold is surgically implanted at the epicenter of the wound after an acute spinal cord injury and acts by appositional healing to spare spinal cord tissue, decrease post-traumatic cyst formation, and decrease spinal cord tissue pressure in preclinical models of spinal cord contusion injury.

InVivo Therapeutics is a biomaterials and biotechnology company with a focus on treatment of spinal cord injuries.