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.
Due to the nature and intended clinical use of autologous chondrocyte implantation, conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.
Ex vivo produced spheroids were implanted in mice (subcutaneous implantation of cartilage explants with human spheroids) or in minipigs (autologous spheroids implanted in cartilage defects). No signs of inflammation, synovitis, infections, rejection, hypertrophy or immune toxicity, tumourigenicity or biodistribution were observed.
A GLP-compliant examination of biodistribution and tumourigenicity in NSG mice showed no signs of biodistribution and/or migration from implanted human spheroids. No suspicion of potential tumourigenesis or increased prevalence of tumours due to the implanted spheroids was observed. In a sheep study, also no biodistribution was observed after injection of spheroids into the knee joint. This suggests that there are no risks for the use of spheroids in humans.
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