Consistency and safety of cell banks for research and clinical use: preliminary analysis of fetal skin banks.

Current restrictions for human cell-based therapies have been related to technological limitations with regards to cellular proliferation capacity, maintenance of differentiated phenotype for primary human cell culture, and transmission of communicable diseases. We have seen that cultured primary fetal cells from one organ donation could possibly meet the exigent and stringent technical aspects for development of therapeutic products. We could develop a master cell bank (MCB) of 50 homogenous ampoules of 4-5 million cells each from one fetal organ donation (skin) in short periods of time compared to other primary cell types. Safety tests were performed at all stages of the cell banking. MCB ampoules could create a working cell bank to be used for clinical or research use. Monolayer culture of fetal skin cells had a life span of 12-17 passages, and independent cultures obtained from the same organ donation were consistent for protein concentration (with 1.4-fold maximal difference between cultures) as well as gene expression of MMP-14, MMP-3, TIMP-3, and VEGF (1.4-, 1.9-, 2.1-, and 1.4-fold maximal difference between cultures, respectively). Cell cultures derived from four independent fetal skin donations were consistent for cell growth, protein concentration, and gene expression of MDK, PTN, TGF-beta1, and OPG. As it is the intention that banked primary fetal cells can profit from the potential 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 upscaling for the preparation of cell transplantation.