The Isolation and Production of the Ready-to-Use Product (the Amniotic Stem Cell Culture) in Accordance with Good Manufacturing Practice Regulations
Kitala, D.; Kawecki, M.; Klama-Baryła, A.; Łabuś, W.; Glik, J.; Kraut, M.łg.; Misiuga, M.; Nowak, M.
Stem Cells and Development 26(9): 694-707
ISSN/ISBN: 1557-8534 PMID: 28117628 DOI: 10.1089/scd.2016.0198
According to the Committee for Advanced Therapies, amniotic stem cells were classified as an advanced therapy medicinal product. This work aims to standardize the isolation of amniotic stem cells and the selection of the optimal time of transplantation and cell application methods in burn patients according to the guidelines of the Good Manufacturing Practice. The placenta used in the study was sourced during a Cesarean section. The remnants of the amnion preparation were placed in a sterile container and transferred to a class B environment, where the primary cultures began. The highest average number of cells was obtained by tissue homogenization and culture growth on the AmnioGrow medium. The isolation of the pure monoculture should be performed using the antibodies against CD105. On the basis of an analysis of population doubling, the aging of a population, the cells' viability, and the severity of injury, the cells should be used between passages 3 and 6. Significant differences were found in the number and viability of cells that were transferred as a full sheet, depending on the transfer method. To sum up, amniotic cells are a promising source in the treatment of burns and can be used as a hospital exemption.