Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Vericel Denmark ApS, Amaliegade 10, DK-1256 Copenhagen K, Denmark
MACI 500,000 to 1,000,000 cells/cm² implantation matrix.
| Pharmaceutical Form |
|---|
|
Implantation matrix. The implant is an opaque, off-white membrane, seeded with chondrocytes, supplied in 18 ml of colourless solution in a dish. |
Each implant contains matrix applied characterised autologous cultured chondrocytes.
Characterised viable autologous chondrocytes expanded ex vivo expressing chondrocyte-specific marker genes, seeded onto a CE marked porcine derived Type I/III collagen membrane.
Each implantation matrix consists of characterised autologous chondrocytes on a 14.5 cm² Type I/III collagen membrane, at a density of 500,000 to 1,000,000 cells per cm², to be trimmed by the surgeon to the size and shape of the defect.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Autologous chondrocytes |
Autologous chondrocyte implantation (ACI) is based on the extraction of the patient’s own chondrocytes isolated from healthy cartilage, their culture in vitro and their subsequent implantation into the cartilage defect. The implantation suspension is cultured and implanted as three-dimensional spheroids. |
| List of Excipients |
|---|
|
Dulbecco’s Modified Eagles Medium (DMEM; Calcium Chloride anhydrous, Ferric Nitrate.9H2O, Potassium Chloride, Magnesium Sulphate anhydrous, Sodium Chloride, Sodium Bicarbonate, Potassium Phosphate Monobasic.H~2~O, D-Glucose, L-Arginine.HCl, L-Cystine.2HCl, L-Glutamine, Glycine, L-Histidine.HCl.H~2~O, L-Isoleucine, L-Leucine, L-Lysine.HCl, L-Methionine, L-Phenylalanine, L-Serine, L-Threonine, L-Tryptophan, L-Tyrosine.2Na.2H~2~O, L-Valine, D-Calcium Pantothenate, Choline Chloride, Folic Acid, i-Inositol, Niacinamide, Riboflavin, Thiamine.HCl, Pyridoxine.HCl) with 4-(2-Hydroxyethyl)piperazine-1-ethanesulfonic acid sodium (HEPES) adjusted for pH with HCl or NaOH and osmality with NaCl. |
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.
Vericel Denmark ApS, Amaliegade 10, DK-1256 Copenhagen K, Denmark
EU/1/13/847/001
Date of first authorisation: 27 June 2013
| Drug | Countries | |
|---|---|---|
| MACI | Estonia, Ireland, Lithuania |
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