How MACI Autologous Knee Cartilage Is Made
Important Safety Information
Full Prescribing Information
Cartilage Repair Blog
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Intended for U.S. health care professionals only

A Manufacturing Process Aligned With GMP Quality Standards

Manufactured MACI Implant

Aseptically manufactured from autologous cells in an FDA-licensed facility

Manufacturing clean rooms maintain the highest cleanliness standards through automated environmental controls and monitoring.

Each phase of manufacturing is monitored and tested for microbial contamination.

Our scientists and engineers are protected by pre-sterilized gowning materials to help reinforce the safe production of MACI.

Chondrocyte Attaches to Collagen Fibers

Uniform Loading Unit (ULU™)

A patient’s characterized cells are distributed onto the MACI membrane in a density of 500,000 to 1,000,000 per cm2 using the proprietary Uniform Loading Unit (ULU). Uniform loading allows for the application of a consistent dose of cells to the defect.

Image shown: High Magnification SEM shows chondrocyte attachment to collagen fibers

Every MACI implant undergoes rigorous release testing to confirm:

Viability

Verifies a sufficient amount of viable chondrocytes for implantation is available

Identity

Uses genetic markers to identify chondrocyte cells

Potency

Validating the ability to form a durable repair tissue

Sterility

Used throughout the process to detect most organisms within 48 hours*

*Sterility results are not available at the time of shipping.

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Indication and Important Safety Information

Important Safety Information

Contraindications: MACI is contraindicated in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides, products of porcine or bovine origin; in patients with severe osteoarthritis of the knee, inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders; in patients who have undergone prior knee surgery in the past 6 months, excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant; or in patients unable to cooperate with a physician-prescribed post-surgical rehabilitation program.

Warnings and Precautions:
  • Malignancy: The risk 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.
  • 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.

Adverse Reactions: The most frequently occurring adverse reactions reported for MACI (≥5%) 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.

Specific Populations:
  • Use of MACI in pediatric patients (younger than 18 years of age) or in patients over 65 years of age has not been established.
  • The MACI implant is not recommended during pregnancy. For implantations post-pregnancy, the safety of breastfeeding to an infant has not been determined.

To report negative side effects, contact Vericel Corporation at 1-800-453-6948 or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.

Please see Full Prescribing Information.

Indication

MACI® 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.

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.