Table 2.
Authorized Autologous Chondrocyte Implantation products.
| Generic name (Trade name) | Marketing authorization holder | Authority | Therapeutic indication | Product formation |
|---|---|---|---|---|
| Autologous cultured chondrocyte (Carticel®) | Genzyme Tissue Repair, Cambridge, MA, US | FDA/CBER (1997) | Use for significant, symptomatic, cartilaginous defects of the femoral condyle (medial, lateral or trochlear) caused by acute or repetitive trauma | Each single use vial has approximately 12 million cells aseptically processed and suspended in 0.4 mL of sterile, buffered DMEM |
| Autologous cultured chondrocyte (ChondroCelect™) | TiGenix N.V., Romeinse straat, Leuven, Belgium | EMA/CAT/CHMP (2009) | Use for 1–5 cm2 single symptomatic cartilage defects of the femoral condyle of the knee in adults. | Package as one falcon tube of product contains approximately 4 million human autologous cells in 0.4 mL the suspension contains cells and excipients DMEM |
| Human autologous implantation tissue (JACC) | Japan Tissue Engineering Co., Ltd., Gamagori, Aichi, Japan | PMDA/Office of Biologics II (2012) | Use for more than 4 cm2 cartilage defect (traumatic cartilage defect or osteochondritis dissecans) of the knee | Package as the cell were three-dimensionally cultured in atelocollagen gel and contains 4.5 × 104 cells |
| Matrix applied characterized autologous cultured chondrocytes (MACI®) | Genzyme Europe B.V., Gooimeer, Naarden, Netherlands | EMA/CAT/CHMP (2013) | Use for 3–20 cm2 full-thickness cartilage defects of the knee of in skeletally mature adult patients | Package as the implantation matrix consists of characterized autologous chondrocytes on a 14.5 cm2 Type I/III collagen membrane, at a density of 0.5 million to 1 million cells per cm2 and 18 mL colourless solution in a dish |
MA, Massachusetts; US, the United States; FDA, Food and Drug Administration; CBER, Center for Biologics Evaluation and Research; DMEM, Dulbecco's. Modified Eagles Medium; EMA, European Medicines Agency; CAT, Committee for Advanced Therapy; CHMP, Committee for Medicinal Products for Human Use; PMDA, Pharmaceutical and Medical Device Agency.