BioSyntech to conclude enrolment for pivotal BST-CarGel(R) trial in February 2009

This randomized trial compares the treatment of cartilage lesions using BST-CarGel(R) applied following microfracture to treatment with microfracture alone. The trial is enrolling subjects aged 18 to 55 years of age with focal cartilage lesions less than 10 cm2 located on the femoral condyles of the...

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Bibliographic Details
Published inCanada NewsWire
Format Newsletter
LanguageEnglish
Published Ottawa PR Newswire Association LLC 13.01.2009
Subjects
Cartilage
Lagueux, Michel
Regenerative medicine
Regulatory approval
Quebec
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Summary:This randomized trial compares the treatment of cartilage lesions using BST-CarGel(R) applied following microfracture to treatment with microfracture alone. The trial is enrolling subjects aged 18 to 55 years of age with focal cartilage lesions less than 10 cm2 located on the femoral condyles of the knee. Subjects are 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 twelve 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. BioSyntech is a medical device company specialized in the development, manufacturing and commercialization of advanced biotherapeutic thermogels for regenerative medicine (tissue repair) and therapeutic delivery. BioSyntech's platform technology is a family of hydrogels called BST-Gel(R), some of which are liquid at low temperature and solid at human body temperature. These gels can be injected or applied to a specific local site and offer beneficial properties for the local repair of damaged tissue such as cartilage, bone and chronic wounds and provide the benefit of avoiding invasive surgery. For additional information, visit www.biosyntech.com.