According to a six-moth post-implant update from Invivo Therapeutics, the fifth patient to be enrolled in the INSPIRE study has achieved an improvement from AIS A to AIS B.
The INSPIRE (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic American Spinal Injury Association Impairment Scale (AIS) A Spinal Cord Injury) study aims to measure AIS improvements associated with the implantation of the Neuro-Spinal Scaffold (Invivo Therapeutics).
All patients enrolled in The INSPIRE Study have complete (AIS A) injuries at the time of enrolment. In the time between the three-month and the six-month post-injury assessment, the fifth patient treated improved from complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury.
The primary endpoint of the INSPIRE study is the proportion of patients with an improvement in AIS grade by the six-month visit. So far, three out of the first five patients treated (60%) have had an AIS grade improvement by 6 months. Several large natural history databases indicate that fewer than 16% of patients with complete thoracic injuries have an AIS grade improvement by six months post injury, according to a company release
As reported previously, the objective performance criterion (OPC) measure of study success for the INSPIRE Study is defined as 25% or more of the patients improving by at least one AIS grade by six months post-implantation.
Mark Perrin, chief executive officer and chairman, says, “We are encouraged to see this patient’s significant neurological progress. This third conversion brings us one step closer to achieving the OPC for the INSPIRE Study. Our goal is to approach full enrolment of the pivotal INSPIRE study by the end of the year, which will allow for [a] humanitarian device exemption submission in 2017.”