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Published on: April 29, 2007
Development of Collagenase Treatment for Dupuytren Disease
Marie A Badalamente1, Lawrence C Hurst2
1Department of Orthopaedics, T-18 Health Science Center, Stony Brook University Medical Center, Room 052, 100 Nicolls Road, Stony Brook, NY 11794, USA.
Abstract:
Proof-of-principle, basic-science studies, using a rat-tail tendon model and surgically removed Dupuytren cords, began collagenase Clostridium histolyticum (CCH) development. Clinical studies in humans were then conducted, where the primary endpoint was reduction in contracture to within 0° to 5° of extension. Phase 2 studies, which confirmed the optimal dose of collagenase as 0.58 mg, showed injectable CCH reduced contractures in MP and PIP joints to within 0° to 5° in many joints and was well tolerated. Clinical results from phase 3 studies confirmed the efficacy and safety of injectable CCH as a viable nonsurgical intervention.
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