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news.BioSyntech, a biotechnology company, has completed enrollment for the Canadian-European pivotal trial of its cartilage repair device, BST-CarGel. The company has achieved its planned objective of enrolling 80 patients into the randomized trial.
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This randomized trial compares the treatment of cartilage lesions using BST-CarGel applied following microfracture to treatment with microfracture alone. The trial enrolled subjects aged 18 to 55 years of age with focal cartilage lesions less than 10cm(2) located on the femoral condyles of the knee. Subjects are further stratified by their lesion type, either characterized as acute or chronic.
The primary endpoint for this trial is cartilage repair at 12 months, defined by the quantity and quality of the repaired tissue as measured with quantitative magnetic resonance imaging. Secondary endpoints are safety and knee-related pain, stiffness and function as measured using the Western Ontario and McMaster Universities osteoarthritis index questionnaire.
Michel Lagueux, chairman of the board of directors of BioSyntech, said: With enrollment now complete, we look forward to the final results from this pivotal trial, which will be available in the first quarter of 2010 and will support marketing applications for BST-CarGel in Canada and Europe. We also continue to advance the investigational device exemption application process with the FDA, for BST-CarGel in the US.