TiGenix announces that positive 5-year follow-up data of the ChondroCelect TIG/ACT/01/2000 clinical study were published in the American Journal of Sports Medicine, one of the highest ranked peer-reviewed orthopaedic journal.
The publication entitled “Five-year outcome of characterized chondrocyte implantation versus microfracture for symptomatic cartilage defects of the knee,” by J. Vanlauwe, D. Saris et al. has been published online ahead of print in the American Journal of Sports Medicine, the official journal of the American Orthopaedic Society for Sports Medicine
The paper describes clinical outcome after 5 years of the multi-centre prospective randomized controlled trial assessing the safety and efficacy of ChondroCelect for the treatment of symptomatic cartilage defects in the knee, as compared to the current standard of care, microfracture. This is the first time a study of this size and duration has been reported and published for an advanced therapy medicinal product. The 5-year follow-up data confirm that the therapeutic effect and the clinical benefit of ChondroCelect gained over baseline at 12 and 36 months is maintained up to at least five years after the cartilage repair intervention. Importantly, the data also confirm the benefit of early intervention in cartilage lesions. Early treatment with ChondroCelect results in a superior clinical benefit over microfracture and a lower failure rate. Conversely, patients who had experienced symptoms for three years or more prior to treatment did not derive substantial long-term benefit from either treatment.
Dr. Johan Vanlauwe, one of the lead investigators of the study, comments: “This study not only demonstrates the long-term durability of the clinical benefit of characterized chondrocyte implantation, but also that maximal clinical benefit can be achieved when patients with cartilage lesions are treated as soon as possible. Therefore we think that cartilage regeneration using ChondroCelect represents a valid therapeutic option provided that the treatment algorithms include time of symptom onset as a key factor.”
TiGenix NV (NYSE Euronext Brussels: TIG) is a leading European cell therapy company with two marketed products, ChondroCelect and ChondroMimetic, and a strong pipeline with clinical stage adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium), and Madrid (Spain), and has facilities in Cambridge (UK) and Sittard-Geleen (the Netherlands).
For more information please visit www.tigenix.com.