BioSyntech to conduct substantial interim analysis on half of enrolled patients from BST-CarGel(R) pivotal trial

The ongoing, randomized BST-CarGel(R) pivotal trial compares the treatment of cartilage lesions using BST-CarGel(R) applied following microfracture to treatment with microfracture alone as a control. The trial enrolled 80 subjects aged 18 to 55 years of age with focal cartilage lesions less than 10...

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Bibliographic Details
Published inCanada NewsWire
Format Newsletter
LanguageEnglish
Published Ottawa PR Newswire Association LLC 12.03.2009
Subjects
Cartilage
Regenerative medicine
Regulatory approval
Quebec
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Summary:The ongoing, randomized BST-CarGel(R) pivotal trial compares the treatment of cartilage lesions using BST-CarGel(R) applied following microfracture to treatment with microfracture alone as a control. The trial enrolled 80 subjects aged 18 to 55 years of age with focal cartilage lesions less than 10 cm(2) located on the femoral condyles of the knee. Subjects were further stratified by their lesion type, either characterized as acute (i.e. traumatic) or chronic (i.e. degenerative). 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 (MRI). Secondary endpoints are safety and knee-related pain, stiffness and function as measured using the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire. Results from this study are intended to support marketing applications in Canada and Europe. Final results of the trial are anticipated in the first half of 2010.