An Autologous Tissue Implant, NeoCart, for Treatment of Hyaline Cartilage Injury in the Knee

NeoCart is an autologous cartilage tissue–engineered implant designed for use in repair of articular cartilage injuries. It uniquely combines a type I bovine-derived collagen scaffold with autogenous chondrocytes and bioreactor treatment. It is currently in the third phase of an investigational study in the United States for treatment of symptomatic articular cartilage lesions of the distal femur. This multicenter, prospective, randomized controlled trial directly compares changes of multiple patient-reported outcome measures over 3 years with a control group undergoing microfracture surgery. This article describes the study design and indications for enrollment in the phase III trial. The technical elements of NeoCart culture and production process, surgical implantation procedure, and rehabilitation guidelines are outlined. In addition, we review previously published findings from the completed phase I safety and phase II exploratory trials.