Cell Therapy
Genzyme has pioneered the field of cell therapy, bringing the first two autologous cell-based therapies for treating serious tissue injury to market and developing extensive manufacturing facilities and logistics expertise. Epicel® (cultured epidermal autografts) is the only permanent autologous epidermal replacement for severe burn victims. Carticel® (autologous cultured chondrocytes) uses similar technology to regrow a patient's own cartilage cells and deliver them back into the damaged area of the knee. Genzyme is now applying its unique autologous cultured cell expertise to other diseases, including heart failure.
Carticel® is for autologous use and is indicated for the repair of symptomatic, cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior surgical repair procedure. It is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis. It is not recommended for patients with total meniscectomy unless surgically reconstructed prior to or concurrent with Carticel implantation. Any instability of the knee or malalignment of the joint should be corrected prior to or concurrent with Carticel implantation. It should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin. In addition, it should not be used in patients who have previously had cancer in the bones, cartilage, fat or muscle of the treated limb. Use in children, patients over age 65, or in joints other than the knee has not yet been assessed. The occurrence of a subsequent surgical procedure, primarily arthroscopy, following Carticel implantation is common. Symptoms leading to arthroscopic intervention have included catching, locking, clicking or pain; patients who develop these symptoms should be evaluated and arthroscopy may be indicated for treatment or further assessment. In post-marketing surveillance, the most frequent operative findings, in descending order of frequency, were graft overgrowth, arthrofibrosis, graft delamination (partial or complete), joint adhesions, meniscus lesion or tear, chondromalacia, loose body, and joint malalignment.
Henri A. Termeer
Genzyme Human Resources
500 Kendall Street
Cambridge, MA 02142
T 617 252 7629
