For the Repair of Articular Cartilage Injuries
Carticel® (autologous cultured chondrocytes), marketed in the United States and Europe by Genzyme Biosurgery, employs a commercial process to culture a patient's own (autologous) cartilage cells, known as chondrocytes, for use in the repair of symptomatic cartilage defects of the femoral condyle (medial, lateral, or trochlear) caused by acute or repetitive trauma in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure. It is not indicated as a treatment for people suffering from osteoarthritis. It is not recommended for use in patients with a known history of allergy to the antibiotic gentamicin, in patients with sensitivities to materials of bovine origin, who have an unstable knee, or who have an abnormal weight distribution within the joint. Patients who have previously had cancer in the bones, cartilage, fat or muscle of the treated limb should also not be treated with Carticel. Any instability of the knee or malalignment of the joint should be corrected before or concurrent with Carticel implantation. Use in children, or in joints other than the knee has not yet been assessed.

Data regarding outcomes beyond 3 years are limited. The most frequently reported adverse events are: hypertrophic tissue at the repair site, intra-articular adhesions, superficial wound infection, hypertrophic synovitis, and post-operative hematoma. See accompanying package insert for additional information on warnings, precautions and adverse events.

Once damaged, joint cartilage does not normally regenerate in the body. In addition to causing pain and restricted mobility, chronic injuries to joint cartilage over time may lead to further deterioration of the joint surface. These manifestations can severely hinder a person's normal activities and occupation.

Some people undergo arthroscopic surgery to smooth the surface of the damaged cartilage area. Other surgical procedures, such as microfracture, drilling, and abrasion, may provide symptomatic relief, but the benefit usually is temporary, especially if the person's pre-injury activity level is maintained. These procedures are performed with the intent of allowing bone marrow cells to infiltrate the defect, resulting in the formation of a fibrous cartilage tissue, which is less durable and resilient than normal articular cartilage.

More severe and chronic forms of knee cartilage damage can lead to greater deterioration of the joint cartilage and may eventually lead to some of the many total knee joint replacements performed each year. Approximately 200,000 total knee replacement operations are performed annually. The artificial joint generally lasts only 10 to 15 years and is therefore not recommended for people under the age of 50 (consult your doctor about this option).

An Option for Patients
The technique of autologous cultured chondrocytes implantation was initially researched at the Hospital for Joint Diseases in New York and further developed at the University of Gothenburg and Sahlgrënska University Hospital, Gothenburg, Sweden, in an effort to provide a treatment option for people with joint cartilage damage.

Carticel is used in people who are experiencing knee pain as a result of an inadequate response to a prior arthroscopic or other cartilage repair procedure. Patients with this type of cartilage damage also display symptoms that include locking, catching, localized pain and swelling.

Carticel Procedure
The procedure starts when a trained orthopedic surgeon provides Genzyme Biosurgery with a biopsy of healthy knee cartilage, about the size of a raisin, from the patient during an arthroscopic procedure. Technicians at the company's FDA licensed cell processing facility in Cambridge, Mass., use proprietary methods to grow millions of new cells for that patient.

The cells are then delivered in a vial to the surgeon who implants them into the defect in a surgical repair procedure. During surgery, the physician carefully removes damaged tissue and prepares the defect for the introduction of the cultured cells. A small piece of the periosteum, the tissue covering a bone, is taken from the patient's lower leg and sutured over the defect like a patch to hold the cells in place. The cultured cells are then implanted under the periosteum in the defect where they can fill the defect with a durable cartilage. Most patients are back to full weight bearing within 6-8 weeks and resume physical activity within one year.

As of March 31, 2000, 3,952 patients had been treated since Genzyme began marketing the product in 1995. There are 136 million people covered by insurance plans that pay for Carticel® (autologous cultured chondrocytes) as a matter of policy in the United States.

Today Carticel® is considered a viable treatment option and most healthcare plans now reimburse fully for appropriate patients - check with your health care administrator where you work for more details or contact us at Genzyme Biosurgery.

For more information, visit Genzyme Biosurgery's Carticel Page.