InVivo Therapeutics has announced a one-month post-implant update for the third study patient and a six-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 complete acute spinal cord injury.
In the time between implantation and the one-month post-injury assessment of the third study patient, the patient improved from complete AIS A spinal cord injury to incomplete AIS B spinal cord injury. The patient has regained sacral sensation with improved bladder function. Historically, fewer than 4% of patients with a high thoracic neurologic level of injury convert from AIS A to AIS B in the first month after injury. There were no reported serious adverse events associated with the Neuro-Spinal Scaffold.
The second patient demonstrated marked improvement in sensory function with partial sensation present five dermatome levels lower on the right side compared to the three-month assessment. This translates to regaining partial sensation from the lower ribs to the hip on the right. The patient continues to make meaningful progress in activities of daily living.
The Neuro-Spinal Scaffold was implanted in both patients by Dom Coric of Carolina Neurosurgery and Spine Associates, chief of neurosurgery at the Carolinas Medical Center in Charlotte, USA. The study is being led by Coric and William Bockenek, chief medical officer of Carolinas Rehabilitation and chairman of the Department of Physical Medicine and Rehabilitation at the Carolinas Medical Center.
Coric said, “I am very encouraged with the third patient’s neurologic recovery following successful implantation of the investigational Neuro-Spinal Scaffold.” Bockenek further stated, “It is exciting and promising when a patient who is classified as a complete spinal cord injury becomes classified as incomplete. This is a relatively unusual occurrence and gives much more potential for further recovery.”
Mark Perrin, InVivo’s chief executive officer, said, “We are excited about the neurologic progress that each of our three study patients has made to date. It is particularly noteworthy that two of the patients improved rapidly within the first month post-injury from a complete to incomplete spinal cord injury. Patient number one improved from AIS A to AIS C in one month which occurs in fewer than 5% of AIS A patients with T10–T12 injury, and patient number three exhibited improvement AIS A to AIS B which historically is observed in fewer than 4% of patients with a T4 injury.
To date, the Neuro-Spinal Scaffold has been successfully implanted in three consecutive patients with no serious adverse events associated with either the scaffold or the surgical procedure.