The INSPIRE Study of the Neuro-Spinal Scaffold™: InVivo Therapeutics Holdings Corp. (NVIV) today announced that the patient enrolled in January in the INSPIRE study of the Neuro-Spinal Scaffold has improved from a complete AIS A spinal cord injury (SCI) to an incomplete AIS B SCI in the time between the one-month and the two-month evaluations. This is the seventh out of the 11 patients (63.6% conversion rate) with at least one month of follow-up to have had an AIS grade improvement.
Two additional patients are early in follow-up and have not yet had their one-month visit. The AIS conversion rate observed in the INSPIRE study to date is considerably higher than published rates observed in a range of SCI natural history databases that are all below 25%.
In addition to the AIS conversion, the patient has also experienced substantial improvements in sensory and motor function. Prior to surgery, the subject had a T12 neurological level of injury with some spared bilateral sensation on the front of the legs and unilateral palpable hip muscle contraction but no ability to move either leg. The patient had no sensory function on the front of the legs from just below the knee and no sensory function on the back of the body from just below the waist. At the two-month visit, the patient was able to move his hips and knees bilaterally and had regained at least some sensory function in almost all regions across the lower legs, feet, and the back of the body from just below the waist.
Travis Dumont, M.D., Director of the Neurovascular Program and Principal Investigator at Banner -University Medical Center Tucson, performed the implantation in January. Dr. Dumont said, “It has been rewarding to be a part of the INSPIRE study and to follow this patient’s recovery. This patient had a very low thoracic neurological level of injury, and such patients have the best prognosis. Nonetheless, I have been impressed with this patient’s recovery to date and am hopeful that the positive trajectory will continue.”
“We are excited to announce the seventh AIS conversion in the INSPIRE study,” CEO and Chairman Mark Perrin said. “We are equally pleased that this patient has experienced considerable motor and sensory improvement over the first two months following injury. We look forward to following the patient’s progress and hope for continued recovery.”
About the Neuro-Spinal Scaffold™ Implant
Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury.