Advanced Cell Therapies

Limitations of Use

It is not known whether MACI is effective in joints other than the knee.

It is not known whether MACI is safe or effective in patients over the age of 55 years.

Important safety information

MACI should not be used if you:

• are allergic to antibiotics such as gentamicin, or materials that come from cow, pig, or ox;
• have severe osteoarthritis of the knee, other severe inflammatory conditions, infections or inflammation in the bone joint and other surrounding tissue, or blood clotting conditions;
• have had knee surgery in the past 6 months, not including surgery for obtaining a cartilage biopsy or a surgical procedure to prepare your knee for a MACI implant;
• or cannot follow a doctor-prescribed rehabilitation program after your surgery

Consult your doctor if you have cancer in the area of the cartilage biopsy or implant as the safety of MACI is not known in those cases.

Conditions that existed before your surgery, including meniscus tears, joint or ligament instability, or alignment problems should be evaluated and treated before or at the same time as the MACI implant.

MACI is not recommended if you are pregnant.

MACI has not been studied in patients younger than 18 or over 55 years of age.

Common side effects include joint pain, tendonitis, back pain, joint swelling, and joint effusion.

More serious side effects include joint pain, cartilage or meniscus injury, treatment failure, and osteoarthritis.

Please see Full Prescribing Information for more information.

Important Safety Information

Epicel is contraindicated in patients with a history of anaphylaxis following exposure to vancomycin, amikacin, and amphotericin, as trace quantities of these anti-infective agents may remain in the Epicel autograft. Epicel should not be used in patients with known sensitivities to materials of bovine or murine origin. It is contraindicated for use on clinically infected wounds.

Because Epicel is manufactured with and contains residual amounts of murine cells, FDA considers it a xenotransplantation product. Therefore, recipients should not donate whole blood, blood components, source plasma, source leukocytes, tissues, breast milk, ova, sperm, or other body parts for use in humans because there is a potential risk of carrying an infection that is transmitted from mouse cells to humans.

Squamous cell carcinoma (SCC) has been reported in patients with burn injury after being grafted with Epicel. Although SCC is a known complication of burn scars, the role of Epicel in the causation of SCC cannot be excluded.

The Epicel product is intended solely for autologous use. Patients undergoing the surgical procedure associated with Epicel are not routinely tested for transmissible infectious diseases. Discontinue use if the patient shows evidence of allergic reaction.

If clinical signs of infection are present of develop, do not apply Epicel until the infection is adequately treated.

The effectiveness of Epicel has not been proven in clinical studies.

The long-term safety of Epicel is unknown. Over the past 27 years, the mortality from all causes was 13% before hospital discharge.

Men and women who intend to have children should be advised tat the effects, if any, of Epicel on fetal development have not been assessed. In addition, the safety of Epicel has not been studied in pregnant and nursing women.

Patient information supplied by attending burn teams from 1989 to 1996 reported the adverse events of highest incidence as: death (13%), infection (13.8%), graft tear (7.8%) or graft blister (4.2%) and drainage (3.3%). Some of these events may have been due to the underlying burn injury and not the device itself.

From June 1998 through September, 2015 adverse events received by Genzyme Biosurgery (predecessor in interest to Vericel) and Vericel Corporation were similar to the previously identified adverse events. Events that were reported in ≥ 1% of patients included multi-organ failure (6.6%), sepsis (5.2%) infection (4%) and skin graft failure/graft complication (2.7%). The relationship of these events to Epicel has not been established.

Please see Patient Information and Directions for Use for more information