Autologous serum is used for cell cultivation to minimize immunogenicity of the product and to avoid the danger of transferring contagious diseases. Well organized and controlled isolation, cultivation and transport conditions guarantee controlled phenotype characteristics, high viability and a low level of apoptosis (programmed cellular death).
The procedures used for controlling the morphological and molecular biological aspects of cultivated cells guarantee the identical cell phenotype and genetic identity of the cells from the biopsy and those after propagation. Tests for sterility (microbiological tests for sterility, Ph.Eur. and PCR-based assays), the quantitative test for bacterial endotoxins (Ph.Eur.) and cell viability tests (trypan blue staining, flow cytometry) ensure the quality of the product for implantation and encourage the trust of surgeons and patients. In addition to this, ‘in vitro’ testing proved that the cells in our final product, ChondroArt™ 3D, maintain the capacity for forming extracellular matrix that is characteristic of normal cartilage.