InVivo Therapeutics updates patient conversions in INSPIRE study
InVivo Therapeutics Holdings provided an update on the progress of the company's INSPIRE Study, which is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold for the treatment of complete thoracic spinal cord injury. The primary endpoint of the study is defined as improvement in ASIA Impairment Scale grade from baseline at the six-month visit. The study update includes: Update on Patient Conversions: A patient improved from complete AIS A SCI to motor incomplete AIS C SCI at the one-month visit. A second patient improved from complete AIS A SCI to sensory incomplete AIS B SCI at the six-month visit. Six of 11 patients have had an AIS grade improvement at the six-month primary endpoint visit. Of the seven conversions, four are AIS C conversions at this time, meaning these four patients have recovered both sensory and motor function. These conversions to AIS C have occurred as early as one month and as late as 24 months after Neuro-Spinal Scaffold implantation. Having assessments of motor improvements occurring one or two years post-implantation is uncommon and may be indicative of prolonged neural repair. One of the two patients who recently converted initially converted from complete AIS A SCI to sensory incomplete AIS B SCI at two months but reverted back to AIS A at three months. Subsequently, at the six-month visit, the patient converted from AIS A to AIS B. This conversion to AIS B at six months will be included in the primary endpoint analysis of AIS improvements from baseline at the six-month visit. The other patient who recently converted was implanted in June 2017 t converted from complete AIS A SCI to motor incomplete AIS C SCI between the hospital discharge and one-month visits. At baseline, the patient was assessed to have a T6 neurological level of injury. In a large European registry, only 2.9% of patients with a T6-T9 NLI were reported to improve to AIS C or better by one month after injury. This is the second patient in the INSPIRE study to have reached AIS C motor incomplete classification at the one-month evaluation and the fourth patient in the INSPIRE study to have reached AIS C motor incomplete classification.