US Approves First Autologous Cell Therapy

The US Food and Drug Administration has approved the first manipulatedautologous structural cell therapy, Genzyme Tissue Repair's Carticel (autologous cultured chondrocytes).

The company says that Carticel received clearance for the "repair of clinically significant, symptomatic cartilaginous defects of the femoral condyle (medial, lateral or trochlear) caused by acute or repetitive trauma." The FDA requires Genzyme Tissue Repair to conduct post-marketing studies to determine the role of the cells in autologous chondrocyte implantation and to assess longer-term clinical outcome. The company says that it had already planned a, 300-patient study, expected to begin this year and end in 2003, to compare its product to other treatment options.