United States of America. The Food and Drug Administration has approved a new product (CarticelR: Genzyme Tissue Repair) that uses a patient’s own cartilage cells in a surgical procedure to repair damage in the knee. The procedure using these cartilage cells, known as autologous cultured chondrocytes, has been approved for the treatment of injuries to the end of the thigh bone behind the kneecap, but not for patients with damage to the kneecap or lower leg bones or arthritis.
This product is the first to be approved that applies procedures described in the guidance document for industry on manipulated autologous structure (MAS). It deals with products comprised of living human cells manipulated outside the body and returned to the patient for structural repair or reconstruction. Treatment with this cell therapy includes harvesting and isolating normal cartilage cells from the knee, culturing and expanding them in the laboratory and then implanting them in the knee.
CarticelR is generally used together with other procedures, including the cutting away of damaged or dead tissue and the surgical addition of tissue taken from the patient’s bones to cover the defect. A thorough and extensive rehabilitation programme, including leg exercises, is also considered critical to recovery.
Until studies are completed that provide a direct comparison between these procedures done with and without CarticelR, it will not be possible to know exactly how much CarticelR contributes to repair of the knee. The sponsor will conduct two randomized controlled studies, one to determine the contribution of the cells to the treatment, and the other to compare long-term (at least 5 years) outcomes in patients treated with CarticelR to other procedures currently in use.
[See also Pharmaceuticals Newsletter No 8, August 1996 and No. 2, February 1996]
Reference: FDA Talk Paper T97-38 dated 25 August 1997.