Is MACI Knee Cartilage Repair Right for Your Patients?
Important Safety Information
Full Prescribing Information
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Is MACI Knee Cartilage Repair Right for Your Patients?

MACI is the third generation of autologous chondrocyte implantation and has made multiple advancements that allow for greater flexibility in treating symptomatic knee cartilage defects in the adult knee.

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.

Close-up of runner's knee


Previous ACIs were only approved for the treatment of the tibiofemoral joints. Because of the versatility offered by the MACI membrane during implantation, surgeons can now treat multiple areas of the knee, including more difficult to treat cartilage damage, like uncontained defects.

MACI is an appropriate option for the defects below:

  • Lateral femoral condyle
  • Medial femoral condyle
  • Patella
  • Trochlea

While MACI can be used for any size defect, it is typically used for full-thickness cartilage defects of the knee. More than 50% of MACI patients are treated for a condyle defect ranging in size from 2 cm2 to 8 cm2.

Other factors to consider when recommending MACI:

 

Patient Age

  • MACI cartilage treatment is approved for patients 18–55. It has not been studied outside of that age range.


Symptoms

  • MACI may be indicated in patients complaining of symptoms including sharp or dull pain in the front of the knee, bone on bone knee pain, pain and stiffness after prolonged sitting ("moviegoers' knee"), intermittent swelling, crepitus, and knee locking or catching.


Getting Patients Back to Activities They Love

  • Has your patient struggled to maintain an active lifestyle because of knee cartilage damage? The patient may be struggling to participate in athletics or even everyday activities, like going down the stairs. MACI can help these knee pain sufferers regain their active lives.

 

Rehabilitation Timeline

  • Recovery from MACI surgery is highly individualized and generally occurs over nine plus months. The rehabilitation program is tailored specifically to each patient's unique goals and objectives. MACI is contraindicated in patients who are unable to follow a physician-prescribed post-surgical rehabilitation program.
  • 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. Please see full ISI and link to PI below.

 

The following patient profiles, based on actual case studies, may help you identify similar patients in your practice who may be eligible MACI candidates:

a single 9 cm2 cartilage lesion with boney involvement in the left medial femoral condylePatient 1 has a single 9 cm2 cartilage lesion with boney involvement in the left medial femoral condyle.

  • Age: 52
  • Gender: Male
  • Occupation: Self-employed
  • Hobbies: Enjoys hiking and tennis
  • Symptoms: Recurrent knee pain from a hiking fall two years ago
  • Prior treatments: None
  • Imaging: Revealed full-thickness cartilage defects on MFC and indicated moderate compartment narrowing with no malalignment

a 2.2 cm2 cartilage lesion in the right lateral femoral condylePatient 2 has a 2.2 cm2 cartilage lesion in the right lateral femoral condyle.

  • Age: 44
  • Gender: Female
  • Occupation: Nurse
  • Hobbies: Enjoys biking, running and hiking
  • Symptoms: Recurrent knee pain for six months
  • Prior treatments: ACL reconstruction two years prior with chondroplasty for cartilage lesion on LFC
  • Imaging: Revealed full-thickness cartilage defect on LFC with no significant joint space narrowing or malalignment

a 9 cm2 trochlea defect and a 4 cm2 patella defect, both in the right kneePatient 3 has a 9 cm2 trochlea defect and a 4 cm2 patella defect, both in the right knee.

  • Age: 20
  • Gender: Female
  • Occupation: Student
  • Hobbies: Volleyball player
  • Symptoms: Pain, swelling, instability >5 years recurrent injury
  • Prior treatment: TTO and lateral release
  • Imaging: Revealed defects on the trochlea and patella

 

 

Please see below for full indication and ISI.

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MACI repairs knee cartilage using your patient’s own chondrocytes

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Watch live MACI case videos with notable orthopedic surgeons.

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Indication and Important Safety Information

Important Safety Information

MACI is contraindicated in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin. MACI is also contraindicated for patients with severe osteoarthritis of the knee, inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders. MACI is also not indicated for use 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.

MACI is contraindicated in patients who are unable to follow a physician-prescribed post-surgical rehabilitation program.

The safety of MACI in patients with malignancy in the area of cartilage biopsy or implant is unknown. Expansion of present malignant or dysplastic cells during the culturing process or implantation is possible.

Patients undergoing procedures associated with MACI are not routinely tested for transmissible infectious diseases. A cartilage biopsy and MACI implant may carry the risk of transmitting infectious diseases to healthcare providers handling the tissue. Universal precautions should be employed when handling the biopsy samples and the MACI product.

Final sterility test results are not available at the time of shipping. In the case of positive sterility results, health care provider(s) will be contacted.

To create a favorable environment for healing, concomitant pathologies that include meniscal pathology, cruciate ligament instability and joint misalignment, must be addressed prior to or concurrent with the implantation of MACI.

Local treatment guidelines regarding the use of thromboprophylaxis and antibiotic prophylaxis around orthopaedic surgery should be followed. Use in patients with local inflammations or active infections in the bone, joint, and surrounding soft tissue should be temporarily deferred until documented recovery.

The MACI implant is not recommended during pregnancy. For implantations post-pregnancy, the safety of breast feeding to infant has not been determined.

Use of MACI in pediatric patients (younger than 18 years of age) or patients over 65 years of age has not been established.

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.

Please see Full Prescribing Information for more information.

Indication

MACI® is an autologous cellularized scaffold product that is indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the adult knee, with or without bone involvement.

MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product that is indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the adult knee, with or without bone involvement.

MACI is intended for autologous use and must only be administered to the patient for whom it was manufactured. The implantation of MACI is to be performed via an arthrotomy to the knee joint under sterile conditions.

The amount of MACI administered is dependent upon the size (surface in cm2) of the cartilage defect. The implantation membrane is trimmed by the treating surgeon to the size and shape of the defect, to ensure the damaged area is completely covered, and implanted cell-side down.

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.