Spinal cord injury (SCI) is a devastating injury with tremendous 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 CDC, SCI costs society an estimated $9.7 billion each year in the United States alone. Yet despite this tremendous expense, the truth is that modern medicine has very few effective weapons to deploy against SCI.
"There is an urgent need for effective therapies to help restore neurological function in patients with acute SCI," said Dr. Michael Fehlings, 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.
On its own, the adult central nervous system cannot regenerate following SCI. Research, however, has shown that with the right treatment, there is potential for regrowth of damaged nerve tissue. Recovery of function depends upon both the severity of the initial injury and on how quickly treatment is given. This is because the chances of regeneration drop quickly the longer an injury lasts.
Researchers in Canada and the United States, led by Dr. Fehlings, are investigating the use of a novel inhibitor, Cethrin?, a man-made protein, in people with acute SCI. This drug has been shown to inhibit cell death and promote neural regeneration in animals.
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 a grade-A SCI. That means they suffered a complete thoracic or cervical injury (i.e., they had no feeling or motor function below the level of the SCI). SCIs are graded A through E, with 'A' designating the most severe SCI and 'E' being normal.
These patients were treated within five days of the SCI incident, with the average time being 53 hours. Increasing doses of Cethrin? (0.3, 1.0, 3.0, and 6 mg.) were administered to the injured spinal cord. The results were:
There were no serious bad effects related to Cethrin?
At 6 weeks, 30.6 percent of patients improved by one or more grades.
The 6-month patient data showed that 28 percent of patients improved by one or more grades. Five patients improved to grade C and two patients improved to grade D.
One patient with a thoracic SCI died from acute respiratory distress syndrome.
"This preliminary research shows great promise for restoring some neurological function for patients with new cases of acute SCI. The positive findings in this Phase I/II trial provide the impetus to proceed to a prospective randomized trial," stated Dr. Fehlings.
The findings were presented April 16, 2007 at the 75th Annual Meeting of the American Association of Neurological Surgeons in Washington, D.C.
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