Background: ChondroCelect® is a medicinal product obtained from the patient´s own cartilage. It is transplanted following the transplantation procedure for autologus chondrocyte transplantation (ACT), a technique designed to regenerate articular cartilage damage. In contrast with other ACT methods, ChondroCelect® is based on the use of a wellcharacterised and potent cell population. This is the first advanced therapy product that has been approved by the European Medicines Agency (October 2009). Objectives: To review the available scientific evidence on the efficacy, safety and efficiency of ChondroCelect® in adult patients with single lesions of the femoral condyle of the knee. Methodology: A systematic review of the available scientific evidence up to December 2010 was performed. Results: The main data on the efficacy of ChondroCelect® have been provided by a randomised phase III clinical trial with high risk of bias which compared ChondroCelect® (n=57) to microfracture (n=61) in adult patients with single cartilage lesions of the femoral condyles of the knee (1-5 cm2 , International Cartilage Repair Society [ICRS] grade III or IV) at twelve and thirty-six months. According to these data, Chondrocelect® is superior to microfracture in structural repair variables, both histomorphometrically as well as histologically, at twelve months after surgery, and comparable to microfracture in the most clinical aspect, as measured by the KOOS score (Knee Injury and Osteoarthritis Outcome Score). Even though the improvement of the overall KOOS score was significant at six months, the difference between groups is not considered clinically relevant. The implantation of Chondrocelect ® is generally well tolerated. The most common adverse events were arthralgia, symptomatic cartilage hypertrophy, articular crepitation, knee swelling and articular effusion. The frequency of adverse events was similar to that of patients that had undergone microfracture. Conclusions: Chondrocelect® is superior to microfracture at short-term in terms of structural repair in accordance with the results yielded by a phase III randomised clinical trial. At long-term, it also shows a superior performance with regard to clinical variables although the differences are not considered relevant.
Knee cartilage injuries; Treatment
Comitè d’Avaluació de Medicaments d’Ús Hospitalari (CAMUH). ChondroCelect® en pacients amb lesions del cartílag del genoll. Barcelona: Agència d’Informació, Avaluació i Qualitat en Salut; 2011.
Use this identifier for quote and/or link this documenthttp://hdl.handle.net/11351/3039
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