Consistency of fetal cell banks for research and clinical use
Current restrictions for human cell-based therapies have been related to technological limitations with regards to cellular proliferation capacity and maintenance of differentiated phenotype for primary human cell culture. In our experience, we have seen that cultured primary fetal cells meet the exigent and stringent technical aspects for development of therapeutic products. As fetal skin cells show rapid growth, Master and Working Cell Banks have been prepared from fetal tissue in short periods of time compared to other primary cell types; one month compared to three or four. Working Cell Banks are then used for subsequent batches of cells for use in research and Tissue Engineering projects. This study focuses on the requirements for fetal tissue selection and testing, cell banking process and testing and growth of cells in production for fetal skin fibroblasts. Depending on the initial concentration of fetal cells seeded, life-span can range from 11-16 weeks of passages in a semi-industrial production protocol. Repetitive cultures from the same tissue show consistent cell culture development when tested for cell growth, protein concentrations, RNA content and gene mRNA expression for genes involved in tissue repair (PTN, MDK, OPG, TGF-β1). As it is the intention that banked primary fetal cells can profit from the prospected treatment of hundreds of thousands of patients with only one organ donation, it is imperative to show consistency, tracability and safety of the process including donor tissue selection, cell banking, cell testing and growth of cells in up-scaling for the preparation of cell transplantation.