Date: 2011-09-19
Type of information:
phase: follow-up
Announcement: results
Company: Tigenix (Belgium)
Product: ChondroCelect®
Action mechanism: autologous, individualized cell therapy
Disease: symptomatic cartilage defects of the knee
Therapeutic area: Bone diseases
Country:
Trial details:
Latest
news: TiGenix has announced 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.
