Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Vericel Denmark ApS, Amaliegade 10, DK-1256 Copenhagen K, Denmark
MACI is indicated for the repair of symptomatic, full-thickness cartilage defects of the knee (grade III and IV of the Modified Outerbridge Scale) of 3-20 cm² in skeletally mature adult patients.
MACI is intended for autologous use only.
MACI must be administered by a surgeon specifically trained and qualified in the use of MACI.
The amount of MACI administered is dependent upon the size (surface in cm²) of the cartilage defect. The implantation matrix 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. The administered dose corresponds to 500,000 to 1,000,000 autologous cells/cm² of implantation matrix.
The use of MACI in this age group has not been studied. The use of MACI in elderly with generalised degeneration of the cartilage or osteoarthritis is not recommended.
The safety and efficacy of MACI in children less than 18 years of age have not been established. No data are available.
For implantation.
The defect bed should be debrided only down to the subchondral plate and not through it. Bleeding through the subchondral plate should be avoided, but if it occurs, it must be controlled. Epinephrine or fibrin sealant (see section 4.5), applied sparingly directly to bleeding points, is a suitable haemostatic agent.
Implantation of MACI is performed using sterile surgical techniques and requires both the preparation of the defect bed and the application of fibrin sealant to the base and rim of the defect in order to secure the implant. At the surgeon’s discretion, a few interrupted absorbable sutures may also be used to provide extra security. The implantation should be followed by an appropriate rehabilitation schedule (see section 4.4).
For information on preparation and handling of MACI, please refer to section 6.6.
Not applicable.
6 days.
Keep MACI in the outer carton until ready to use. Do not refrigerate or freeze. Store shipping box in an area below 37°C.
MACI is shipped in custom-designed, sterile, sealed, clear polystyrene dishes.
Each dish contains 1 implantation matrix, held in place by a green polycarbonate x-ring and closed with a green polycarbonate cover for shipment.
Each dish is sealed in a gamma-irradiated clear plastic bag.
MACI is supplied in 1 to 2 dishes, which are placed into a 95kPa pouch (outer bag) with absorbent material for transport.
This package is enclosed in an outer carton insulated with ambient gel packs.
During the first procedure, a sample of healthy cartilage tissue (a biopsy) will be taken from the affected joint by an arthrotomy or arthroscopy.
The biopsy will be sent to the cell processing facility. At the cell processing facility, the cartilage cells will be grown aseptically in culture to expand the number of cells and placed onto a sterile CE marked porcine derived type I/III collagen membrane, to make MACI. MACI will be released following successful results from assays which assess chondrocyte viability, identity, potency, minimum cell number, endotoxin, pre-release sterility, and mycoplasma.
MACI will be sent to the treatment facility. At this time, MACI will be implanted into the cartilage defect in the affected joint via a second procedure. The MACI implant will be secured in place using a fibrin sealant.
The timing between the removal of the biopsy and MACI implantation can vary depending on logistical factors in addition to the quality and number of cells obtained from the biopsy. The minimum amount of time is 6 weeks; however, cells can also be cryopreserved and held in storage for up to 24 months until a surgical date is established.
The surgeon will organise the date for MACI implantation in consultation with the Marketing Authorisation Holder (MAH) or its local representative. In rare cases the MAH will not be able to produce a MACI implant from the available cells. If this occurs, the surgeon will advise the patient on the best course of action.
Any unused medicinal product or waste material should be disposed of as surgical waste in accordance with local requirements.
Please consult the Surgical Technique Manual for further information.
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