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欧洲干细胞系的库、储存库和登记处:监管与伦理方面

Banks, repositories and registries of stem cell lines in Europe: regulatory and ethical aspects.

作者信息

Hug Kristina

机构信息

Department of Medical Ethics, Lund University, Lund, Sweden.

出版信息

Stem Cell Rev Rep. 2009 Mar;5(1):18-35. doi: 10.1007/s12015-009-9053-5. Epub 2009 Feb 10.

DOI:10.1007/s12015-009-9053-5
PMID:19205929
Abstract

To overview banks, repositories and registries of stem cell lines in Europe excluding bone marrow and cord blood banks; to concisely discuss the most important scientific, regulatory and ethical aspects of stem cell banking in a manner understandable to a layperson, but remain detailed enough not to compromise thoroughness of information. Review of scientific publications, laws and ethical guidelines in this field up through September 2008; hearing the opinions of key persons working in stem cell banking. The article discusses the procedure of stem cell banking and related safety issues and reviews the regulation of stem cell banking at the regional (European) and the national level. Stem cell banking can help meet scientific and certain ethical imperatives, but is complicated in the context of heterogeneous laws, guidelines, and ethical standards. In the pluralistic European society with cultural diversity leading to heterogeneous laws, harmonisation of international guidelines and national laws regulating stem cell banking is needed, as well as mapping of implementation at the national level.

摘要

概述欧洲除骨髓库和脐带血库之外的干细胞系库、储存库和登记处;以非专业人士能够理解的方式简要讨论干细胞库最重要的科学、监管和伦理方面,但仍要详细到不影响信息的全面性。回顾截至2008年9月该领域的科学出版物、法律和伦理准则;听取干细胞库领域关键人士的意见。本文讨论了干细胞库的程序及相关安全问题,并回顾了区域(欧洲)和国家层面的干细胞库监管情况。干细胞库有助于满足科学和某些伦理需求,但在法律、准则和伦理标准各异的背景下情况较为复杂。在文化多样性导致法律各异的多元欧洲社会中,需要统一规范干细胞库的国际准则和国家法律,以及在国家层面进行实施情况的梳理。

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Integrated Collection of Stem Cell Bank Data, a Data Portal for Standardized Stem Cell Information.综合干细胞库数据收集,标准化干细胞信息的数据门户。
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本文引用的文献

1
Development of a European human embryonic stem cell registry.欧洲人类胚胎干细胞登记处的建立。
Regen Med. 2008 Nov;3(6):945-51. doi: 10.2217/17460751.3.6.945.
2
The generation of six clinical-grade human embryonic stem cell lines.六种临床级人类胚胎干细胞系的产生。
Cell Stem Cell. 2007 Nov;1(5):490-4. doi: 10.1016/j.stem.2007.10.004.
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Integration of immunological aspects in the European Human Embryonic Stem Cell Registry.欧洲人类胚胎干细胞登记处中免疫学方面的整合。
Monash Bioeth Rev. 2015 Dec;33(4):265-76. doi: 10.1007/s40592-015-0050-y.
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Regulatory insight into the European human pluripotent stem cell registry.对欧洲人类多能干细胞登记处的监管洞察。
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Centralized banks for human embryonic stem cells: a worthwhile challenge.人类胚胎干细胞集中库:一项值得应对的挑战。
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International banking: checks, deposits, and withdrawals.国际银行业务:支票、存款和取款。
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Harmonizing standards and coding for hESC research.协调人胚胎干细胞研究的标准与编码。
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Q & A: Anna Veiga. Interviewed by Doug Sipp.问答:安娜·维加。由道格·西普采访。
Nat Med. 2008 Mar;14(3):234. doi: 10.1038/nm0308-234.
8
Registries and banks.登记处和库。
Nat Cell Biol. 2008 Feb;10(2):111. doi: 10.1038/ncb0208-111.
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Banking on it: public policy and the ethics of stem cell research and development.寄希望于此:公共政策与干细胞研发伦理
Soc Sci Med. 2007 Oct;65(7):1490-500. doi: 10.1016/j.socscimed.2007.05.021. Epub 2007 Jun 27.
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Characterization of human embryonic stem cell lines by the International Stem Cell Initiative.国际干细胞研究协会对人类胚胎干细胞系的特征描述
Nat Biotechnol. 2007 Jul;25(7):803-16. doi: 10.1038/nbt1318. Epub 2007 Jun 17.