title: The Isolation and Production of the Ready-to-Use Product (the Amniotic Stem Cell Culture) in Accordance with Good Manufacturing Practice Regulations.
abstract: 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.
authors.affiliation: 1 Dr. Stanislaw Sakiel Burn Treatment Centre , Siemianowice Śląskie, Poland .
authors.forename: Diana
authors.initials: D
authors.lastname: Kitala
authors.affiliation: 1 Dr. Stanislaw Sakiel Burn Treatment Centre , Siemianowice Śląskie, Poland .|2 Department of Emergency Medicine, School of Health Sciences, University in Bielsko-Biała , Bielsko-Biała, Poland .
authors.forename: Marek
authors.initials: M
authors.lastname: Kawecki
authors.affiliation: 1 Dr. Stanislaw Sakiel Burn Treatment Centre , Siemianowice Śląskie, Poland .
authors.forename: Agnieszka
authors.initials: A
authors.lastname: Klama-Baryła
authors.affiliation: 1 Dr. Stanislaw Sakiel Burn Treatment Centre , Siemianowice Śląskie, Poland .
authors.forename: Wojciech
authors.initials: W
authors.lastname: Łabuś
authors.affiliation: 1 Dr. Stanislaw Sakiel Burn Treatment Centre , Siemianowice Śląskie, Poland .|3 Department of Chronic Wounds Management Organization, School of Health Sciences, Medical University of Silesia , Siemianowice Śląskie, Poland .
authors.forename: Justyna
authors.initials: J
authors.lastname: Glik
authors.affiliation: 1 Dr. Stanislaw Sakiel Burn Treatment Centre , Siemianowice Śląskie, Poland .
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Kraut
authors.affiliation: 1 Dr. Stanislaw Sakiel Burn Treatment Centre , Siemianowice Śląskie, Poland .
authors.forename: Marcelina
authors.initials: M
authors.lastname: Misiuga
authors.affiliation: 1 Dr. Stanislaw Sakiel Burn Treatment Centre , Siemianowice Śląskie, Poland .
authors.forename: Mariusz
authors.initials: M
authors.lastname: Nowak
mesh_terms: D000650:Amnion / Q000166:cytology*; D002056:Burns / Q000628:therapy*; D018929:Cell Culture Techniques / Q000379:methods / Q000592:standards; D049109:Cell Proliferation; D002469:Cell Separation / Q000379:methods / Q000592:standards; D002470:Cell Survival; D002478:Cells, Cultured; D005260:Female; D006801:Humans; D017410:Practice Guidelines as Topic / Q000592:standards; D011247:Pregnancy; D033581:Stem Cell Transplantation / Q000379:methods*; D013234:Stem Cells / Q000166:cytology*; D013997:Time Factors; D014945:Wound Healing
keywords: Good Manufacturing Practice; amnion; stem cells