A second subject has been enrolled in the pilot study of the InVivo Therapeutics Neuro-Spinal Scaffold for the treatment of complete traumatic spinal cord injury (SCI).
Last week, as we reported here, InVivo Therapeutics got the green light to enrol a second patient into its pilot study which is intended to evaluate the safety and feasibility of the Neuro-Spinal Scaffold as well as to gather preliminary evidence of effectiveness. Once the pilot trial of five patients has been completed, InVivo expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).
The patient was recruited at the Carolinas Medical Center, part of the Carolinas HealthCare System in Charlotte, NC., where they were operated on by investigator Dr. Domagoj Coric and his partner Dr. John Ziewacz. This then became only the second-ever Neuro-Spinal Scaffold implant into an acute spinal cord injury patient.
Dr. Coric commented, “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. The implantation procedure was a success, and I look forward to monitoring the subject’s progress.”
Mark Perrin, InVivo’s CEO, said, “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. As previously stated, the 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.”
Source: Business Wire