Data from FDA - Curated by Toby Galbraith - Last updated 19 May 2017

Licensing authority

FDA (Food and Drug Administration, USA)

Indication(s)

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. (1)
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.

Full Prescribing information

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Advisory information

contraindications
• Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin. (4)
• Severe osteoarthritis of the knee. (4)
• Inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders. (4)
• Prior knee surgery (within 6 months), excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant. (4)
• Inability to cooperate with a physician-prescribed post-surgical rehabilitation program. (4)
Special warnings and precautions
• Safety of MACI in patients with 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. (5.1)
• 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. (5.2)
• 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. (5.3)
• Final sterility test results are not available at the time of shipping. (5.4)
Adverse reactions

The most frequently occurring adverse reactions (≥5%) reported for MACI were arthralgia, tendonitis, back pain, joint swelling, and joint effusion. (6)

Serious adverse reactions reported for MACI were arthralgia, cartilage injury, meniscus injury, treatment failure, and osteoarthritis. (6)

Usage information

Dosing and administration
For autologous implantation only.
• Contact Vericel at 1-800-453-6948 or www.MACI.com regarding training materials for surgical implantation of MACI. (2)
• The amount of MACI implanted depends on the size (surface area in cm2) of the cartilage defect. (2.1)
• MACI should be trimmed to the size and shape of the defect and implanted with the cell-side down. (2.2)
Use in special populations
Pregnancy: Because MACI implantation requires invasive surgical procedures, use in pregnancy is not recommended. (8.1)

More information

Category Value
Authorisation number BLA125603
Orphan designation No
Product NDC 69866-1030
Date First Approved 11-01-2017
Marketing authorisation holder Vericel Corporation

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