title: Microbiological control in stem cell banks: approaches to standardisation.
abstract: The transplant of cells of human origin is an increasingly complex sector of medicine which entails great opportunities for the treatment of a range of diseases. Stem cell banks should assure the quality, traceability and safety of cultures for transplantation and must implement an effective programme to prevent contamination of the final product. In donors, the presence of infectious micro-organisms, like human immunodeficiency virus, hepatitis B virus, hepatitis C virus and human T cell lymphotrophic virus, should be evaluated in addition to the possibility of other new infectious agents (e.g. transmissible spongiform encephalopathies and severe acute respiratory syndrome). The introduction of the nucleic acid amplification can avoid the window period of these viral infections. Contamination from the laboratory environment can be achieved by routine screening for bacteria, fungi, yeast and mycoplasma by European pharmacopoeia tests. Fastidious micro-organisms, and an adventitious or endogenous virus, is a well-known fact that will also have to be considered for processes involving in vitro culture of stem cells. It is also a standard part of current good practice in stem cell banks to carry out routine environmental microbiological monitoring of the cleanrooms where the cell cultures and their products are prepared. The risk of viral contamination from products of animal origin, like bovine serum and mouse fibroblasts as a "feeder layer" for the development of embryonic cell lines, should also be considered. Stem cell lines should be tested for prion particles and a virus of animal origin that assure an acceptable quality.
authors: Stem Cell Bank of Andalucía (Spanish Central Node), Hospital Universitario Virgen de las Nieves, Avda Fuerzas Armadas, 2, 18014, Granada, Spain. fernancobo@fundacionhvn.org
authors: Fernando
authors: F
authors: Cobo
authors: Glyn N
authors: GN
authors: Stacey
authors: Charles
authors: C
authors: Hunt
authors: Carmen
authors: C
authors: Cabrera
authors: Ana
authors: A
authors: Nieto
authors: Rosa
authors: R
authors: Montes
authors: José Luis
authors: JL
authors: Cortés
authors: Purificación
authors: P
authors: Catalina
authors: Angela
authors: A
authors: Barnie
authors: Angel
authors: A
authors: Concha
mesh_terms: D018070:Biological Specimen Banks; D002478:Cells, Cultured / Q000382:microbiology*; D004866:Equipment Contamination; D006801:Humans; D013234:Stem Cells / Q000382:microbiology*; D020858:Tissue and Organ Harvesting / Q000592:standards*