2 The technologies
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Autologous chondrocyte implantation (ACI) |
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Marketing authorisations |
The OsCell John Charnley Laboratory has approval from the Medicines and Healthcare products Regulatory Agency to provide traditional ACI services under a hospital exemption from the advanced therapy medicinal products regulation for products prepared on a non-routine basis. It also has approval from the Human Tissues Authority for procuring, testing, storing and importing human tissues and cells for human application, and storing relevant material that has come from a human body for use for a scheduled purpose. The indication for use of traditional ACI in the knee is for the repair of single or multiple symptomatic, full-thickness cartilage defects of the joint with or without bone involvement in adults. Traditional ACI involves implanting a cell suspension under either a periosteal- or collagen-based membrane. Traditional ACI can be considered when the Oswestry Risk of Knee Arthroplasty (ORKA) score is 3 or 4, but only when other factors can be corrected, for example, using meniscal allograft or realignment osteotomy. Matrix-associated chondrocyte implantation (MACI) had a European marketing authorisation for the repair of symptomatic, full-thickness cartilage defects of the knee (grades III and IV of the Modified Outerbridge Scale) between 3 cm2 and 20 cm2. The marketing authorisation is currently suspended while Vericel validates a new site for culturing cells. ChondroCelect had a European marketing authorisation for repair of symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society grades III or IV), which was withdrawn by TiGenix during the course of this appraisal for commercial reasons. ACI is contraindicated in people with severe osteoarthritis of the knee. |
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Price |
Costs may vary in different settings because of negotiated procurement discounts. The recommendations are based on a maximum cell cost of £16,000. |