InVivo Therapeutics has announced a three-month update for the first subject in the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in subjects with acute spinal cord injury. The Neuro-Spinal Scaffold was implanted in the subject in October 2014 at the Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center in Phoenix, USA by Nicholas Theodore, chief of spinal surgery.
In the time between implantation and the three-month post-injury assessment, there were no reported serious adverse events associated with the Neuro-Spinal Scaffold and the subject had progressed from a complete AIS A injury to an incomplete AIS C injury with motor, sensory, bowel, and bladder function improvements. Motor improvement from the pre-surgery assessment to the three-month visit involved the return of active movement of the hip flexors against gravity (allowing for leg to chest motions) and palpable contractions of the knee extensors. Sensory improvement from the pre-surgery assessment to the three-month visit involved the bilateral return of sensation to two dermatomes extending down the top of the subject’s legs and the S4–S5 dermatome. In addition, the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam, the Spinal Cord Independence Measure (SCIM III) exam, and additional assessments of bowel and bladder function demonstrated that between hospital discharge and the three-month visit, the subject has regained bowel function and improved bladder function.
Theodore said, “I am very pleased with the first subject’s progress since the scaffold was implanted. In my experience, this degree of sensory and motor improvement is unexpected. However, this is only one patient and we do not want to over-interpret the data.”
Mark Perrin, InVivo’s chief executive officer, said, “We are impressed with the first subject’s progress to date since comparable spontaneous recovery occurs infrequently in patients with similar injuries. We look forward to continuing to evaluate the Neuro-Spinal Scaffold in this first subject and the remaining subjects planned for this study.”
The data from the first subject were obtained and calculated in accordance with the ISNCSCI, the standard examination used to determine motor and sensory impairment and severity of a spinal cord injury. This is the company’s first clinical study of its 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, InVivo expects to conduct a pivotal study to obtain FDA approval to commence commercialisation under a Humanitarian Device Exemption (HDE).