INDICATION

MACI® (autologous cultured chondrocytes on porcine collagen membrane) is made up of your own (autologous) cells that are expanded and placed onto a film that is implanted into the area of the cartilage damage and absorbed back into your own tissue.

MACI is used for the repair of symptomatic cartilage damage of the adult knee.

The amount of MACI applied depends on the size of the cartilage damage. The MACI film is trimmed by your surgeon to match the size and shape of the damage, to ensure the damaged area is completely covered.

Limitations of Use

The safety and long-term clinical benefit of MACI has only been studied in the knee joint.

The safety and effectiveness of MACI have not been proven for patients 55 years old and older.

IMPORTANT SAFETY INFORMATION

MACI should not be used if you:

• are allergic to antibiotics such as gentamicin, or materials that come from cow, pig, or ox;
• have severe osteoarthritis of the knee, other severe inflammatory conditions, infections in the bone joint and other surrounding tissue, or blood clotting conditions;
• have had knee surgery in the past 6 months, not including surgery for obtaining a cartilage biopsy or a surgical procedure to prepare your knee for a MACI implant;
• or cannot follow a doctor-prescribed rehabilitation program after your surgery
• Consult your doctor if you have cancer in the area of the cartilage biopsy or implant as the safety of MACI is not known in those cases.

Conditions that existed before your surgery, including meniscus tears, joint instability or alignment problems should be evaluated and treated before or at the same time as the MACI implant.

MACI is not recommended if you are pregnant or breast feeding.

MACI has not been studied in patients younger than 18 or over 55 years of age.

Common side effects include joint pain, cold-like symptoms, and headaches.

More serious side effects include joint pain, cartilage or meniscus injury, treatment failure, and osteoarthritis.