Spinal cord injury (SCI) is one of the most significant forms of neurotrauma with major economic and social impact.
Every year, nearly 12,000 individuals in the United States and Canada, mostly young adults, sustain a SCI. According to the Centers for Diseases Control and Prevention (CDC), SCI costs an estimated $9.7 billion each year in the United States alone. Although there are some early pharmacological and surgical interventions that may diminish the severity of SCI, the overall impact of these treatments remains minimal. “There is an urgent need for effective therapies to help restore neurological function in patients with acute SCI,” said Michael Fehlings, MD, PhD, FRCSC, FACS, head of the Krembil Neuroscience Center at the University Health Network in Toronto and a professor of Neurosurgery at the University of Toronto. Dr. Fehlings is leading a trial conducted in Canada and the United States, sponsored by BioAxone Therapeutique (Montreal, Canada), and more recently, Boston Life Sciences, Inc. to examine a novel treatment for individuals with SCI.
The findings of this study, Results of the Cethrin Phase I/IIa Prospective Clinical Trial of a Rho Inhibitor for the Treatment of Acute Spinal Cord Injury, were presented by Dr. Fehlings during the 75th Annual Meeting of the American Association of Neurological Surgeons in Washington, D.C. Co-authors are Nicholas Theodore, MD, James Harrop, MD, Gilles Maurais, MD, Charles Kuntz, MD, Christopher Shaffrey, MD, Brian Kwon, MD, Jens Chapman, MD, Albert Yee, MD, Patrick Tremblay, PhD, and Lisa McKerracher, PhD.
Without medical intervention, axons in the adult central nervous system cannot regenerate following SCI. Research, however, has shown the potential for regrowth of damaged axons. Recovery of function depends upon the severity of the initial injury. It is important that treatment is undertaken as quickly as possible because there is less chance of regeneration the longer the duration of the injury.
Researchers in Canada and the United States, led by Dr. Fehlings, are investigating the use of a novel Rho inhibitor, Cethrin®, (a recombinant protein) formulated with a fibrin sealant in patients with acute SCI. This drug has been shown to inhibit cell death and promote neural regeneration in animal models of SCI. Rho is a signaling master switch whose activation triggers cell death and increases damage after SCI.
Thirty-seven patients with acute SCI were enrolled in the one-year study at nine sites across Canada and the United States. All patients were classified with American Spinal Injury Association (ASIA) A SCI. That means they suffered a complete thoracic or cervical injury (i.e. having no sensory or motor function below the level of the SCI). ASIA grades are designated from A through E, with ‘A' designating complete SCI, and ‘E' being normal. Grades ‘B' through ‘D' designate decreasing levels of neurological involvement.