The Cambridge, Mass.-based company’s neuro-spinal scaffold is designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.
InVivo said that the 2 patients improved from sensory incomplete AIS B spinal cord injuries to motor incomplete AIS C injuries during their most recent assessments as part of the trial.
One of the improved patients was enrolled last May, and converted from complete AIS A SCI to incomplete AIS B SCI at 3 months, then was assessed to have improved to incomplete AIS C SCI at their 12-month follow-up.
“The patient’s continued improvement at the 1 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,” principal investigator Dr. Stuart Lee, who assessed the 1st patient, said in a press release.
The 2nd improved patient was enrolled in June 2015 and converted from complete AIS A SCI to incomplete AIS B SCI at a 1-month exam that July. At 24 months, the patient was assessed to be AIS C with the ability to contract 2 muscles in 1 leg.
“This patient moved from AIS A to AIS B shortly after the initial injury and implantation with the neuro-spinal scaffold 2 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,” co-principal investigator Dr. William Bockenek of Carolina Neurosurgery and Spine Associates, where the 2nd patient was treated, said in a prepared statement.
The 2 AIS C improvements bring the total number of patients who’ve recovered to that level up to 3, InVivo said.
“We are excited that these two patients have continued to progress beyond the period of early improvement. Three of the five patients with an AIS conversion in Inspire have demonstrated motor recovery and are now classified as AIS C conversions. Having assessments of motor improvements occurring one or two years post-implantation is uncommon and may be indicative of prolonged neural repair,” CEO & chair Mark Perrin said in prepared remarks.
In May, the company said that 2 neuro-spinal scaffold trial patients who had reportedly improved had reverted to their original injury state.
The company said that a patient it had announced in January had improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury was recently assessed to have reverted back to a complete AIS A spinal cord injury.