Autologous cultured chondrocytes and Pork collagen

MACI ® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults. Limitations of Use Effectiveness of MACI in joints other than the knee has not been established. Safety and effectiveness of MACI in patients over the age of 55 years have not been established. MACI ® is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.

No clinical pharmacology studies have been conducted with MACI and a mechanism of action has not been established.

For Autologous Implantation Only. Contact Vericel at 1-800-453-6948 or www.MACI.com regarding training materials for surgical implantation of MACI. The amount of MACI implanted depends on the size (surface area in cm 2 ) of the cartilage defect. MACI should be cut to the size and shape of the defect and implanted with the cell-side down.

MACI is contraindicated in patients with the following conditions: Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin. Severe osteoarthritis of the knee (Kellgren-Lawrence grade 3 or 4). Inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders. Prior knee surgery (6 months), excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant. Inability to cooperate with a physician-prescribed post-surgical rehabilitation program. Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin.

Malignancy: The risk of malignancy in the area of cartilage biopsy or implant is unknown. Expansion of malignant or dysplastic cells present in biopsy tissue during manufacture and subsequent implantation may be possible. Transmissible infectious diseases: Because patients undergoing procedures associated with MACI are not routinely tested for transmissible infectious diseases, cartilage biopsy and MACI implant may carry risk of transmitting infectious diseases. Presurgical Comorbidities: Local inflammation or active infection in the bone, joint, and surrounding soft tissue, meniscal pathology, cruciate ligament instability, and misalignment should be assessed and treated prior to or concurrent with MACI implantation. Product Sterility: Final sterility test results are not available at the time of shipping.

The most frequently occurring adverse reactions (≥5%) reported for MACI were arthralgia, tendonitis, back pain, joint swelling, and joint effusion. Serious adverse reactions reported for MACI were arthralgia, cartilage injury, meniscus injury, treatment failure, and osteoarthritis. Serious adverse reactions reported for MACI were arthralgia, cartilage injury, meniscus injury, treatment failure, and osteoarthritis. for voluntary reporting of adverse reactions.

Store MACI at room temperature in its original packaging (outer box) until ready to use. DO NOT REFRIGERATE or FREEZE, or sterilize MACI.