Carticel improvement sustained for 10 years

US biotechnology major Genzyme has reported strong data from a large, multicenter, observational study that investigated the long-term durability of Carticel (autologous cultured chondrocytes) in patients who had pain and functional impairment from defects in the articular cartilage of their knee. According to data presented at the annual meeting of the American Academy of Orthopaedic Surgeons, held in San Francisco, almost 90% of patients treated with Carticel who experienced improvement in knee function at an early follow-up, sustained their improvement for up to almost 10 years.

At their early follow-up, 75% of all patients experienced significant improvement in their knee function (mean improvement of 4.3 in overall condition on the Modified Cincinnati knee rating system). Of those patients, 87% sustained improvement at the later follow-up time point.

Carticel was the first cell therapy to be approved by the Food and Drug Administration. First introduced in March 1995, Carticel received accelerated approval from the agency in August 1997. Under accelerated approval, the FDA required Genzyme to conduct confirmatory post-marketing studies that were completed and, in June 2007, the US regulator deemed the commitment satisfied.