InVivo Therapeutics has announced a six-month post-implant update for the first study patient and a three-month post-implant update for the second study patient in the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury. The Neuro-Spinal Scaffold was implanted in the first patient in October 2014 at the Barrow Neurological Institute, Phoenix, USA, and in the second patient in January 2015 at the Carolinas Medical Center, Charlotte, USA.
From the three-month assessment to the six-month assessment, the first patient has demonstrated continued improvement in motor function as assessed by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. The patient has regained partial function of knee extensors and remains classified as ASIA Impairment Scale C (AIS C) with a motor incomplete spinal cord injury. The second patient remains classified as AIS A with a complete spinal cord injury. Of note is the appreciable improvement in the second patient’s trunk stability, self-care, mobility and bowel and bladder function at the three-month post-implant assessment. There have been no reported adverse events associated with the Neuro-Spinal Scaffold to date in either patient.
Lorianne Masuoka, InVivo’s chief medical officer, added, “We would like to acknowledge the high level of care that our study patients are receiving by the neurosurgical and rehabilitation teams at the Barrow Neurological Institute and Carolinas Medical Center. The videos of our study patients posted on various social media outlets have proven both inspiring and scientifically valuable as we consider supplementing standard assessments with additional measures to identify motor improvement in trunk and hip muscles that are not evaluated as part of the standard ISNCSCI exam. We may add these assessments to the protocol of the ongoing pilot study or a future study to supplement the ISNCSCI exam.”
“I am very pleased with the improvements observed with the first two patients who have received our Neuro-Spinal Scaffold. The second patient’s progress is encouraging since the injury and the patient’s condition at presentation were more severe, delaying spinal stabilisation, decompression, and scaffold implantation. We look forward to following the patients’ progress over the coming months and hope that they will demonstrate continued improvement,” said Mark Perrin, InVivo’s chief executive officer and chairman of the board.
In March, the company announced the reopening of enrolment for the remaining three patients of its pilot trial in patients with acute thoracic spinal cord injury.