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From banking to international governance: fostering innovation in stem cell research.从银行业到国际治理:促进干细胞研究的创新。
Stem Cells Int. 2011;2011:498132. doi: 10.4061/2011/498132. Epub 2011 Sep 5.
2
Stem cell banking: between traceability and identifiability.干细胞库:在可追溯性和可识别性之间。
Genome Med. 2010 Oct 5;2(10):73. doi: 10.1186/gm194.
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Governing stem cell banks and registries: emerging issues.管理干细胞库和登记处:新出现的问题。
Stem Cell Res. 2009 Sep-Nov;3(2-3):96-105. doi: 10.1016/j.scr.2009.05.003. Epub 2009 May 25.
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Ethics and Governance of Stem Cell Banks.干细胞库的伦理与管理
Methods Mol Biol. 2017;1590:99-112. doi: 10.1007/978-1-4939-6921-0_7.
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Alliances, collaborations and consortia: the International Stem Cell Forum and its role in shaping global governance and policy.联盟、合作与联合体:国际干细胞论坛及其在塑造全球治理与政策中的作用。
Regen Med. 2012 Nov;7(6 Suppl):84-8. doi: 10.2217/rme.12.79.
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Banks, repositories and registries of stem cell lines in Europe: regulatory and ethical aspects.欧洲干细胞系的库、储存库和登记处:监管与伦理方面
Stem Cell Rev Rep. 2009 Mar;5(1):18-35. doi: 10.1007/s12015-009-9053-5. Epub 2009 Feb 10.
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Quality Assurance in Stem Cell Banking: Emphasis on Embryonic and Induced Pluripotent Stem Cell Banking.干细胞库的质量保证:重点在于胚胎干细胞库和诱导多能干细胞库。
Methods Mol Biol. 2017;1590:11-16. doi: 10.1007/978-1-4939-6921-0_2.
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The UK Stem Cell Bank: a UK government-funded, international resource center for stem cell research.英国干细胞库:一个由英国政府资助的国际干细胞研究资源中心。
Regen Med. 2006 Jan;1(1):139-42. doi: 10.2217/17460751.1.1.139.
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The International Stem Cell Banking Initiative (ISCBI): raising standards to bank on.国际干细胞库协会(ISCBI):提高标准,为存储而努力。
In Vitro Cell Dev Biol Anim. 2010 Apr;46(3-4):169-72. doi: 10.1007/s11626-010-9301-7. Epub 2010 Mar 3.
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Report of the International Stem Cell Banking Initiative Workshop Activity: Current Hurdles and Progress in Seed-Stock Banking of Human Pluripotent Stem Cells.国际干细胞库倡议研讨会活动报告:人类多能干细胞种子库存储的当前障碍和进展。
Stem Cells Transl Med. 2017 Nov;6(11):1956-1962. doi: 10.1002/sctm.17-0144. Epub 2017 Oct 24.

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A double encryption protection algorithm for stem cell bank privacy data based on improved AES and chaotic encryption technology.基于改进 AES 和混沌加密技术的干细胞库隐私数据双重加密保护算法。
PLoS One. 2023 Oct 25;18(10):e0293418. doi: 10.1371/journal.pone.0293418. eCollection 2023.
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Considerations for an integrated population health databank in Africa: lessons from global best practices.非洲综合人口健康数据库的考量:全球最佳实践的经验教训
Wellcome Open Res. 2021 Aug 23;6:214. doi: 10.12688/wellcomeopenres.17000.1. eCollection 2021.
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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。
Stem Cell Reports. 2021 Apr 13;16(4):997-1005. doi: 10.1016/j.stemcr.2021.02.014. Epub 2021 Mar 18.
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A blueprint for the next generation of ELSI research, training, and outreach in regenerative medicine.再生医学领域下一代伦理、法律和社会问题(ELSI)研究、培训及推广的蓝图。
NPJ Regen Med. 2017 Jul 5;2:21. doi: 10.1038/s41536-017-0026-z. eCollection 2017.
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The Clinical Applications of Endometrial Mesenchymal Stem Cells.子宫内膜间充质干细胞的临床应用
Biopreserv Biobank. 2018 Apr;16(2):158-164. doi: 10.1089/bio.2017.0057. Epub 2017 Dec 21.
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Uncertainty and innovation: Understanding the role of cell-based manufacturing facilities in shaping regulatory and commercialization environments.不确定性与创新:理解基于细胞的制造设施在塑造监管和商业化环境中的作用。
Appl Transl Genom. 2016 Nov 11;11:27-39. doi: 10.1016/j.atg.2016.11.001. eCollection 2016 Dec.
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The Use of Induced Pluripotent Stem Cells for the Study and Treatment of Liver Diseases.诱导多能干细胞在肝脏疾病研究与治疗中的应用。
Curr Protoc Toxicol. 2016 Feb 1;67:14.13.1-14.13.27. doi: 10.1002/0471140856.tx1413s67.
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Stem cell research funding policies and dynamic innovation: a survey of open access and commercialization requirements.干细胞研究资助政策与动态创新:对开放获取和商业化要求的调查。
Stem Cell Rev Rep. 2014 Aug;10(4):455-71. doi: 10.1007/s12015-014-9504-5.
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Policy recommendations for addressing privacy challenges associated with cell-based research and interventions.应对基于细胞的研究和干预措施相关隐私挑战的政策建议。
BMC Med Ethics. 2014 Feb 3;15:7. doi: 10.1186/1472-6939-15-7.
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Standard requirement of a microbiological quality control program for the manufacture of human mesenchymal stem cells for clinical use.人用间充质干细胞生产用微生物质量控制标准。
Stem Cells Dev. 2014 May 15;23(10):1074-83. doi: 10.1089/scd.2013.0625. Epub 2014 Feb 20.

本文引用的文献

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The commercialization of genomic research in Canada.加拿大基因组研究的商业化
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Stem cells: The growing pains of pluripotency.干细胞:多能性的成长烦恼。
Nature. 2011 May 19;473(7347):272-4. doi: 10.1038/473272a.
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Clinical trials for stem cell therapies.干细胞疗法的临床试验。
BMC Med. 2011 May 10;9:52. doi: 10.1186/1741-7015-9-52.
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Human iPSC and ESC translation potential debated.人类诱导多能干细胞和胚胎干细胞的翻译潜力引发争议。
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Risk factors in the development of stem cell therapy.干细胞治疗发展中的风险因素。
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6
Access to stem cells and data: persons, property rights, and scientific progress.获取干细胞和数据:人与财产权和科学进步。
Science. 2011 Feb 11;331(6018):725-7. doi: 10.1126/science.1201382.
7
Balancing open source stem cell science with commercialization.平衡开源干细胞科学与商业化。
Nat Biotechnol. 2011 Feb;29(2):115-6. doi: 10.1038/nbt.1773.
8
Publishing SNP genotypes of human embryonic stem cell lines: policy statement of the International Stem Cell Forum Ethics Working Party.发布人类胚胎干细胞系的 SNP 基因型:国际干细胞论坛伦理工作组政策声明。
Stem Cell Rev Rep. 2011 Sep;7(3):482-4. doi: 10.1007/s12015-010-9226-2.
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Korean deaths spark inquiry.韩国人的死亡引发调查。
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The paradoxical problem with multiple-IRB review.多机构审查委员会审查中自相矛盾的问题。
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从银行业到国际治理:促进干细胞研究的创新。

From banking to international governance: fostering innovation in stem cell research.

机构信息

Centre of Genomics and Policy, McGill University, Montreal, QC, Canada H3A 1A1.

出版信息

Stem Cells Int. 2011;2011:498132. doi: 10.4061/2011/498132. Epub 2011 Sep 5.

DOI:10.4061/2011/498132
PMID:21904557
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3167189/
Abstract

Stem cell banks are increasingly recognized as an essential resource of biological materials for both basic and translational stem cell research. By providing transnational access to quality controlled and ethically sourced stem cell lines, stem cell banks seek to foster international collaboration and innovation. However, given that national stem cell banks operate under different policy, regulatory and commercial frameworks, the transnational sharing of stem cell materials and data can be complicating. This paper will provide an overview of the most pressing challenges regarding the governance of stem cell banks, and the difficulties in designing regulatory and commercial frameworks that foster stem cell research. Moreover, the paper will shed light on the numerous international initiatives that have arisen to help harmonize and standardize stem cell banking and research processes to overcome such challenges.

摘要

干细胞库越来越被认为是基础和转化干细胞研究的生物材料的重要资源。通过提供跨国界获取经过质量控制和符合伦理标准的干细胞系,干细胞库旨在促进国际合作和创新。然而,由于国家干细胞库在不同的政策、监管和商业框架下运作,因此跨国界共享干细胞材料和数据可能会变得复杂。本文将概述与干细胞库治理相关的最紧迫挑战,以及在设计促进干细胞研究的监管和商业框架方面所面临的困难。此外,本文还将介绍为帮助协调和标准化干细胞库和研究过程以克服这些挑战而出现的众多国际举措。