MACI® (autologous cultured chondrocytes on porcine collagen membrane) is made up of a patient's own (autologous) cells that are expanded and placed onto film that can be absorbed back into your own tissue and is implanted into the area where the cartilage damage was removed.
MACI is used for the repair of symptomatic, deep cartilage damage of the adult knee that may or may not affect the bone.
MACI should only be applied in the operating room to the person for whom it was made.
The amount of MACI applied depends on the size of the cartilage damage. The MACI film is trimmed by the surgeon to match the size and shape of the damage, to ensure the damaged area is completely covered. Multiple implants may be used if there is more than one area of damage.
Limitations of Use
The safety and long-term clinical benefit of MACI have only been studied in the knee joint. MACI has not been approved for use in joints other than the knee.
The safety and effectiveness of MACI has not been proven for patients 55 years old and older.
MACI should not be used in patients who are allergic to antibiotics such as gentamicin, or materials of cow, porcine or ox origin.
MACI should not be used if you have severe osteoarthritis of the knee, other severe inflammatory conditions, infections in the bone joint and other surrounding tissue, or blood clotting conditions.
MACI is not approved for patients who have had knee surgery in the past 6 months. This does not include surgery for obtaining a cartilage biopsy or a surgical procedure to prepare your knee for a MACI implant.
MACI should not be used in patients who cannot follow a doctor-prescribed rehabilitation program after their surgery.
The safety of MACI in patients with cancer in the area of the cartilage biopsy or implant is not known. Cancer cells could be expanded during the culturing process.
Patients are not tested for infectious disease and may transfer infectious diseases to the surgeon handling the MACI implant.
If your MACI implant is not sterile, your surgeon will be notified before your surgery.
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.
The MACI implant is not recommended for pregnant patients or patients who are breast feeding.
Use of MACI in children (younger than 18 years of age) or patients over 65 years of age has not been studied.
The most common side effects for MACI include joint pain (arthralgia), tendonitis, back pain, joint swelling, and joint fluid (effusion).
More serious side effects include joint pain, cartilage injury, meniscus injury, treatment failure, and osteoarthritis.
Please see Full Prescribing Information for more information