Genzyme Corporation announced that the US Food and Drug Administration (FDA) has approved new labelling for Carticel (autologous cultured chondrocytes) based on the completion of a post-approval commitment study. This label incorporates safety and efficacy data from the Study of the Treatment of Articular Repair (STAR) as a result of Genzyme's successful completion of this final confirmatory, post-marketing study.
"Genzyme has pioneered cartilage repair in the field of orthopaedics and sports medicine for more than a decade," said Ann Merrifield, president of Genzyme Biosurgery, the division that manufactures and commercializes Carticel. "Now, the successful completion of our final FDA post-approval commitment further confirms Carticel's safety and effectiveness for patients with troublesome and debilitating cartilage injuries in the knee. Carticel has already benefited thousands of patients with specific types of cartilage injuries where there traditionally have been limited treatment options. With this new data on-label, we hope to provide all appropriate patients access to therapy."
The STAR study investigated the safety and effectiveness of Carticel in patients who had an inadequate response to a previous cartilage repair procedure in the knee. Investigators enrolled patients in 29 clinical centers in this prospective 4-year study, which achieved all of its endpoints. The data from the STAR study will be presented at the upcoming American Orthopaedic Society for Sports Medicine (AOSSM) Meeting on Sunday, July 15, 2007 in Calgary, Canada.
"Carticel has been established as a unique and valuable tool for orthopaedic surgeons in the treatment of patients with cartilage injuries in the knee. Accordingly, it is important that all appropriately indicated patients have access to this technology," said David Levine, M.D., Vice President, Clinical Research for Genzyme Biosurgery. "Now that the post-approval commitments have been completed, we are confident that health plans that had yet to cover this treatment option will adopt the appropriate medical policy for Carticel."
Carticel is used by orthopaedic surgeons to treat patients who have clinically significant articular cartilage lesions on the thigh bone part of the knee caused by acute or repetitive trauma that has not responded to a prior cartilage repair procedure. Carticel should only be used in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. Carticel employs a unique process to grow a patient's own cartilage cells for implantation to correct certain types of damage. The treatment starts when an orthopaedic surgeon trained in the use of Carticel provides Genzyme with a biopsy of healthy cartilage taken from a patient's knee in an arthroscopic procedure. Technicians at Genzyme's cell culture laboratory in Cambridge, MA use proprietary methods to grow millions of cells from this biopsy. The cells are then delivered to the hospital, where the surgeon implants them into the patient's knee defect in a surgical procedure.
Carticel was the first cell therapy to be approved by the FDA. First introduced in March of 1995, Carticel received accelerated approval from the FDA in August of 1997 after the FDA instituted specific cell therapy guidelines. Under accelerated approval, the FDA required Genzyme to conduct confirmatory post-marketing studies.
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 arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft). Carticel should only be used in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. It is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis. It is not recommended for patients whose knee meniscus has been surgically removed unless the patient has undergone surgical reconstruction prior to or concurrent with Carticel implantation.
Pre-existing conditions including meniscal tears, joint instability 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. Carticel is not routinely tested for transmissible infectious diseases and may transmit disease to the healthcare provider handling Carticel. 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. The most common reactions (>5% of patients), derived from the Study of the Treatment of Articular Repair (STAR), include arthrofibrosis/joint adhesions, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion, graft delamination, and osteoarthritis.