InVivo Therapeutics Holdingsss Corp (NVIV) announced Wednesday that two patients with Spinal Cord Injury or SCI, who were enrolled in the INSPIRE experiment of its Neuro-Spinal Scaffold, have shown encouraging improvement in the most recent assessments of the INSPIRE trials.
The patient who was enrolled in May last year with “Complete AIS A SCI” had shown progress in the first “three-month- INSPIRE-assessment” in August 2016 converting to “Incomplete AIS B SCI.”
In the next INSPIRE assessment which was after 12 months since enrollment the patient was found to have “regained motor function associated with the most sacral segments of the spinal cord” – meaning the patient had further improved to “Incomplete AIS C SCI.”
M.D. Stuart Lee, the Principal Investigator at Vidant Medical Center in Greenville, North Carolina, where this patient was implanted with the Neuro-Spinal Scaffold had this to say in regards to the INSPIRE assessment:
“The patient’s continued improvement at the one-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.”
The second patient had joined the INSPIRE trials in June 2015 with “Complete AIS A SCI” and converted to “Incomplete AIS B SCI” at the one-month-assessment in July that year. At the 24-month ISNCSCI test the patient was assessed to be “AIS C” showing the ability to contract two muscles of one leg.
Dr. William Bockenek of Carolinas Rehabilitation who, along with Domagoj Coric, M.D., of Carolina Neurosurgery and Spine Associates, is the co-investigator at the facility where the implantation of the Neuro-Spinal Scaffold was carried out on this patient said:
“This patient moved from AIS A to AIS B shortly after the initial injury and implantation with the Neuro-Spinal Scaffold two 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.”
These two SCI sufferers bring the total number to three patients who have reached AIS C motor incomplete classification with the Neuro-Spinal Scaffold implant under the INSPIRE experiment.
This is what the CEO and Chairman of InVivo, Mark Perrin, said in regards to the assessments:
“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.”
Headquartered in Cambridge – MA, InVivo Therapeutics Holdings Corp is a research and clinical-stage biomaterials and biotechnology company primarily involved in the treatment of spinal cord injuries.
Established in 2005 the company has received the following awards for its outstanding and praiseworthy contribution to spinal cord injury treatment and research.
In 2011, the company won the David S. Apple Award from the “American Spinal Injury Association” for its outstanding contribution to spinal cord injury medicine.
In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award.
InVivo was founded with the proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who at the time was at Boston Children’s Hospital and is now affiliated with Massachusetts General Hospital.
What exactly is the Neuro-Spinal Scaffold implant and how is it done? Here’s how InVivo answers that question.
“Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural repair within and around the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in The INSPIRE Study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury.”
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) is an all-encompassing neurological test conducted to determine sensory and motor impairments in SCI patients. The ISNCSCI is published by the American Spinal Injury Association (ASIA) formed in 1973.
It is on the ISNCSCI findings that the American Spinal Injury Association Impairment Scale (AIS) grade classification is based.