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依据中国法规对临床级别的生物安全人胚胎干细胞进行认证。

Accreditation of Biosafe Clinical-Grade Human Embryonic Stem Cells According to Chinese Regulations.

机构信息

State Key Laboratory of Stem Cell and Reproductive Biology, Institute of Zoology, Chinese Academy of Sciences, Beijing 100101, China.

State Key Laboratory of Stem Cell and Reproductive Biology, Institute of Zoology, Chinese Academy of Sciences, Beijing 100101, China; University of Chinese Academy of Sciences, Beijing 100049, China.

出版信息

Stem Cell Reports. 2017 Jul 11;9(1):366-380. doi: 10.1016/j.stemcr.2017.04.017. Epub 2017 May 11.

DOI:10.1016/j.stemcr.2017.04.017
PMID:28506532
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5511037/
Abstract

Human embryonic stem cells (hESCs) are promising in regenerative medicine. Although several hESC-based clinical trials are under way, a widely accepted standard of clinical-grade cells remains obscure. To attain a completely xeno-free clinical-grade cell line, the system must be free of xenogenic components, the cells must have a comprehensive set of functions, and good manufacturing practice conditions must be used. In this study, following these criteria, we successfully derived two hESC lines, which were thereby considered "clinical-grade embryonic stem cells". In addition to the primary capacity for pluripotency, these two cell lines were efficiently differentiated into various types of clinical-grade progeny. Importantly, the cells were recognized by the National Institutes for Food and Drug Control of China for further eligible accreditation. These data indicate that we have established completely xeno-free clinical-grade hESC lines and their derivatives, which will be valuable for the foundation of an international standard for clinical-grade cells for therapy.

摘要

人类胚胎干细胞（hESCs）在再生医学中具有广阔的应用前景。目前已经有多项基于 hESC 的临床试验正在进行，但仍缺乏广泛认可的临床级细胞标准。为了获得完全无动物源的临床级细胞系，该系统必须不含异种成分，细胞必须具有全面的功能，且必须使用良好的生产规范条件。在这项研究中，我们根据这些标准成功地获得了两个 hESC 系，因此被认为是“临床级胚胎干细胞”。除了多能性的基本能力外，这两个细胞系还能有效地分化为各种类型的临床级后代。重要的是，这些细胞已通过中国食品药品检定研究院的进一步合格认证。这些数据表明，我们已经建立了完全无动物源的临床级 hESC 系及其衍生物，这将为建立治疗用临床级细胞的国际标准奠定基础。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82ad/5511037/db1cd376d1b4/gr5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82ad/5511037/374ed0b38fc5/fx1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82ad/5511037/ae8831eaa425/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82ad/5511037/33ab5627e9a8/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82ad/5511037/6a2f0e4c3741/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82ad/5511037/506453276000/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82ad/5511037/db1cd376d1b4/gr5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82ad/5511037/374ed0b38fc5/fx1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82ad/5511037/ae8831eaa425/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82ad/5511037/33ab5627e9a8/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82ad/5511037/6a2f0e4c3741/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82ad/5511037/506453276000/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82ad/5511037/db1cd376d1b4/gr5.jpg

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J Tissue Eng Regen Med. 2018 Jan;12(1):153-163. doi: 10.1002/term.2381. Epub 2017 Jun 9.
2
New regulation for clinical stem cell research in China: expected impact and challenges for implementation.中国临床干细胞研究新规定：预期影响及实施挑战
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Points to consider in the development of seed stocks of pluripotent stem cells for clinical applications: International Stem Cell Banking Initiative (ISCBI).
PD-L1 Promotes Immunological Tolerance and Enhances Visual Protection of hESC-RPE Grafts in Retinal Degeneration.
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Cell Prolif. 2025 Aug;58(8):e70007. doi: 10.1111/cpr.70007. Epub 2025 Feb 14.
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Stem cell transplantation extends the reproductive life span of naturally aging cynomolgus monkeys.干细胞移植可延长自然衰老食蟹猴的生殖寿命。
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