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Microbiological control in stem cell banks: approaches to standardisation.干细胞库中的微生物控制：标准化方法
Appl Microbiol Biotechnol. 2005 Sep;68(4):456-66. doi: 10.1007/s00253-005-0062-2. Epub 2005 Oct 26.
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Microbiological contamination in stem cell cultures.干细胞培养中的微生物污染。
Cell Biol Int. 2007 Sep;31(9):991-5. doi: 10.1016/j.cellbi.2007.03.010. Epub 2007 Mar 20.
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Diagnostic approaches for viruses and prions in stem cell banks.干细胞库中病毒和朊病毒的诊断方法。
Virology. 2006 Mar 30;347(1):1-10. doi: 10.1016/j.virol.2005.11.026. Epub 2005 Dec 27.
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Environmental monitoring in stem cell banks.干细胞库中的环境监测。
Appl Microbiol Biotechnol. 2006 May;70(6):651-62. doi: 10.1007/s00253-006-0326-5. Epub 2006 Mar 10.
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Environmental microbial contamination in a stem cell bank.干细胞库中的环境微生物污染。
Lett Appl Microbiol. 2007 Apr;44(4):379-86. doi: 10.1111/j.1472-765X.2006.02095.x.
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GMP scale-up and banking of pluripotent stem cells for cellular therapy applications.用于细胞治疗应用的多能干细胞的GMP放大培养及冻存。
Methods Mol Biol. 2011;767:147-59. doi: 10.1007/978-1-61779-201-4_11.
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Operator-induced contamination in cell culture systems.细胞培养系统中操作人员引起的污染。
Dev Biol Stand. 1991;75:193-204.
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Cornea. 2013 Aug;32(8):1155-66. doi: 10.1097/ICO.0b013e31828f9d64.
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Swiss Fetal Transplantation Program and Non-enzymatically Isolated Primary Progenitor Cell Types for Regenerative Medicine.瑞士胎儿移植计划与用于再生医学的非酶法分离原代祖细胞类型
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Insect cells: adventitious agents.昆虫细胞：外来因子
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RSC Med Chem. 2020 Feb 19;11(3):349-357. doi: 10.1039/c9md00529c. eCollection 2020 Mar 1.
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The quality evaluation system establishment of mesenchymal stromal cells for cell-based therapy products.基于细胞治疗产品的间充质基质细胞质量评价体系的建立。
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Generation of pancreatic β cells for treatment of diabetes: advances and challenges.用于治疗糖尿病的胰腺 β 细胞的生成：进展与挑战。
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A review of the emerging potential therapy for neurological disorders: human embryonic stem cell therapy.神经疾病新兴潜在疗法综述：人类胚胎干细胞疗法
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本文引用的文献

1
Mycoplasma contamination of cell cultures: Incidence, sources, effects, detection, elimination, prevention.支原体污染细胞培养：发生率、来源、影响、检测、清除、预防。
Cytotechnology. 2002 Jul;39(2):75-90. doi: 10.1023/A:1022913015916.
2
Autologous peripheral blood progenitor cells are a potential source of parvovirus B19 infection.自体外周血祖细胞是细小病毒B19感染的一个潜在来源。
Transfusion. 2005 Mar;45(3):394-8. doi: 10.1111/j.1537-2995.2005.04267.x.
3
Detection of mycoplasma contaminations.支原体污染的检测
Methods Mol Biol. 2005;290:13-23. doi: 10.1385/1-59259-838-2:013.
4
Detection of HIV-1 and HCV infections among antibody-negative blood donors by nucleic acid-amplification testing.通过核酸扩增检测在抗体阴性献血者中检测HIV-1和HCV感染。
N Engl J Med. 2004 Aug 19;351(8):760-8. doi: 10.1056/NEJMoa040085.
5
Probability of viremia with HBV, HCV, HIV, and HTLV among tissue donors in the United States.美国组织捐献者中乙肝病毒（HBV）、丙肝病毒（HCV）、人类免疫缺陷病毒（HIV）和人类嗜T淋巴细胞病毒（HTLV）血症的概率。
N Engl J Med. 2004 Aug 19;351(8):751-9. doi: 10.1056/NEJMoa032510.
6
Preclinical vCJD after blood transfusion in a PRNP codon 129 heterozygous patient.一名PRNP密码子129杂合子患者输血后发生临床前变异型克雅氏病。
Lancet. 2004;364(9433):527-9. doi: 10.1016/S0140-6736(04)16811-6.
7
Coupling multiplex RT-PCR to a gene chip assay for sensitive and semiquantitative detection of severe acute respiratory syndrome-coronavirus.将多重逆转录聚合酶链反应与基因芯片检测相结合用于严重急性呼吸综合征冠状病毒的灵敏和半定量检测。
Lab Invest. 2004 Sep;84(9):1085-91. doi: 10.1038/labinvest.3700136.
8
UK opens embryonic stem cell bank.英国开设胚胎干细胞库。
Lancet. 2004 May 29;363(9423):1778. doi: 10.1016/S0140-6736(04)16341-1.
9
First stem cell bank in the world is opened in UK.世界上第一家干细胞库在英国开业。
BMJ. 2004 May 29;328(7451):1277. doi: 10.1136/bmj.328.7451.1277-a.
10
Presence of TT virus DNA in bone marrow cells from hematologic patients.
New Microbiol. 2004 Apr;27(2):113-7.

干细胞库中的微生物控制：标准化方法

Microbiological control in stem cell banks: approaches to standardisation.

作者信息

Cobo Fernando, Stacey Glyn N, Hunt Charles, Cabrera Carmen, Nieto Ana, Montes Rosa, Cortés José Luis, Catalina Purificación, Barnie Angela, Concha Angel

机构信息

Stem Cell Bank of Andalucía (Spanish Central Node), Hospital Universitario Virgen de las Nieves, Avda Fuerzas Armadas, 2, 18014, Granada, Spain.

出版信息

Appl Microbiol Biotechnol. 2005 Sep;68(4):456-66. doi: 10.1007/s00253-005-0062-2. Epub 2005 Oct 26.

DOI:10.1007/s00253-005-0062-2
PMID:16012832
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7080164/
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.

摘要

人类源细胞移植是医学中一个日益复杂的领域，为一系列疾病的治疗带来了巨大机遇。干细胞库应确保用于移植的培养物的质量、可追溯性和安全性，并且必须实施有效的计划以防止最终产品受到污染。对于供体，除了评估其他新型感染因子（如可传播性海绵状脑病和严重急性呼吸综合征）的可能性外，还应评估是否存在传染性微生物，如人类免疫缺陷病毒、乙型肝炎病毒、丙型肝炎病毒和人类嗜T细胞病毒。核酸扩增技术的引入可以避免这些病毒感染的窗口期。通过欧洲药典测试对细菌、真菌、酵母和支原体进行常规筛查，可以检测出实验室环境中的污染。挑剔的微生物以及外来或内源性病毒是干细胞体外培养过程中也必须考虑的一个众所周知的事实。对制备细胞培养物及其产品的洁净室进行常规环境微生物监测，也是干细胞库当前良好操作规范的标准组成部分。还应考虑动物源性产品（如牛血清和作为胚胎细胞系“饲养层”的小鼠成纤维细胞）带来病毒污染的风险。干细胞系应检测朊病毒颗粒和动物源性病毒，以确保质量合格。