The ninth spinal cord injury patient in the INSPIRE trial—implanted with InVivo Therapeutics’ neuro-spinal scaffold last month—is showing signs of improvement. The patient is the fifth of eight patients in the company’s study to show an American Spinal Injury Association grade improvement.
The product is surgically implanted following acute spinal cord injury to act as a physical substrate for nerve sprouting.
The 9th patient in a clinical trial improved from a complete to incomplete spinal cord injury on the American Spinal Injury Association’s 50-point lower extremity motor score between the 2nd and 3rd month after implantation.
Chairman and chief executive officer Mark Perrin says, “If we continue to observe American Spinal Injury Association score conversions at a similar rate, we will dramatically exceed the objective performance criterion measure of study success. Our current conversion rate is four times the rate in natural history databases, which is extremely encouraging. We look forward to completing the INSPIRE study as quickly as possible and applying for [a humanitarian device exemption from the US Food and Drug Administration (FDA)] in 2017.”
“The evidence obtained to date in the Inspire study is tremendously encouraging. It has been rewarding to be involved in the study and to observe this patient’s recovery to date, and I hope that the patient continues to make progress,” adds Stuart Lee of Vidant Medical Center in Greenville, USA.
Northwestern Medicine (Chicago, USA) has also been added as a new site for the INSPIRE study. The Northwestern Memorial Hospital is an 894-bed Level I trauma centre.
“Chicago, as with other major metropolitan areas, sees a disproportionally high number of acute, traumatic spinal cord injuries and unfortunately, with complete spinal cord injuries, trauma teams have limited tools at their disposal to treat this devastating condition. I look forward to being a part of the encouraging INSPIRE study,” says Nader Dahdaleh, assistant professor in Neurological Surgery and principal investigator at the study site.
There are now 23 North American clinical sites participating in the clinical study:
Banner University Medical Center, Tucson
Barnes-Jewish Hospital at Washington University Medical Center, St Louis
Ben Taub Hospital/Baylor College of Medicine, Houston
Barrow Neurological Institute – St. Joseph’s Hospital and Medical Center, Phoenix
Carolina Neurosurgery and Spine Associates/Carolinas Rehabilitation, Charlotte
Cooper Neurological Institute, Camden
Goodman Campbell Brain and Spine/Indiana University Health Neuroscience Center, Indianapolis
Hospital of the University of Pennsylvania, Philadelphia
Keck Hospital of University of Southern California, Los Angeles
Medical College of Wisconsin/Froedtert Hospital, Milwaukee
Mount Sinai Hospital, New York City
Northwestern Medicine, Chicago
Oregon Health & Science University, Portland
Rutgers New Jersey Medical School, Newark
Thomas Jefferson University Hospital, Philadelphia
Toronto Western Hospital, Toronto, Canada
University of California, Davis Medical Center, Sacramento
University of California, San Diego Medical Center, San Diego
University of Kansas Medical Center, Kansas City
University of Louisville Hospital, Louisville
University of Pittsburgh Medical Center Presbyterian, Pittsburgh
University of Virginia Health System, Charlottesville
Vidant Medical Center, Greenville