InVivo Therapeutics has announced that two patients in the INSPIRE study of the Neuro-Spinal Scaffold have improved from sensory incomplete AIS B spinal cord injury (SCI) to motor incomplete AIS C SCI in their most recent INSPIRE assessments. These are the second and third patients in the INSPIRE study to have reached AIS C motor incomplete classification.
One of these patients was enrolled in May 2016 and converted from complete AIS A SCI to incomplete AIS B SCI at the three-month exam in August 2016. At the 12-month visit, the patient regained motor function associated with the most sacral segments of the spinal cord and was assessed to be AIS C. Stuart Lee, is the principal investigator at Vidant Medical Center in Greenville, North Carolina, where this patient was implanted with the Neuro-Spinal Scaffold.
Lee says, “The patient’s continued improvement at the one year exam is encouraging. Return of sacral motor function may be related to improvements in bowel and bladder function that can have an appreciable impact on a patient’s quality of life. We look forward to monitoring this patient’s recovery and hope for continued progress.”
The second patient was enrolled in June 2015 and converted from complete AIS A SCI to incomplete AIS B SCI at the one-month exam in July 2015. At the 24-month per protocol ISNCSCI (International Standards For Neurological Classification of Spinal Cord Injury) , the patient was assessed to be AIS C with the ability to contract two muscles of one leg. The motor function was not noted in a separate medical evaluation earlier in the day that did not include a full ISNCSCI exam. Domagoj Coric of Carolina Neurosurgery and Spine Associates, and William Bockenek, of Carolinas Rehabilitation, are co-principal investigators at the site where this patient was implanted.
Bockenek says, “This patient moved from AIS A to AIS B shortly after the initial injury and implantation with the Neuro-Spinal Scaffold two years ago, and now is noted on the ISNCSCI exam to have moved to an AIS C based on trace movements in one leg. Though the clinical significance of this change is unknown at this time, we remain cautiously optimistic that there may be a possibility for additional changes.”