| 人胚胎干细胞诱导分化的肝样细胞质量评价研究 |
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| 引用本文： | 纳涛,孙懿,吴婷婷,欧阳琦,卢光琇,林戈,袁宝珠. 人胚胎干细胞诱导分化的肝样细胞质量评价研究[J]. 中国新药杂志, 2021, 0(4): 320-332 |
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| 作者姓名： | 纳涛 孙懿 吴婷婷 欧阳琦 卢光琇 林戈 袁宝珠 |
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| 作者单位： | 中国食品药品检定研究院;人类干细胞国家工程研究中心;湖南光琇高新生命科技有限公司 |
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| 摘 要： | 肝细胞、肝组织或器官移植是目前不可逆失代偿性肝病的主要治疗手段,而由人胚胎干细胞诱导分化来源的肝样细胞(human embryonic stem cells-derived hepatocyte-like cells,hESC-HLCs)能为移植提供数量充足、质量可控、来源稳定的细胞.为满足临床应用研究的需要,hESC...
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| 关 键 词： | 胚胎干细胞 肝样细胞 质量属性 质量评价 阶段性诱导分化 |
A discussion on the quality evaluation practice of human embryonic stem cells-derived hepatocyte-like cells |
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| NA Tao,SUN Yi,WU Ting-ting,OUYANG Qi,LU Guang-xiu,LIN Ge,YUAN Bao-zhu. A discussion on the quality evaluation practice of human embryonic stem cells-derived hepatocyte-like cells[J]. Chinese Journal of New Drugs, 2021, 0(4): 320-332 |
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| Authors: | NA Tao SUN Yi WU Ting-ting OUYANG Qi LU Guang-xiu LIN Ge YUAN Bao-zhu |
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| Affiliation: | (The Cell Collection and Research Center,National Institutes for Food and Drug Control,Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products,Beijing 100050,China;National Engineering and Research Center of Human Stem Cells,Changsha 410205,China;Hunan Guangxiu GaoXin Life Science Co.,Ltd.,Changsha 410205,China) |
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| Abstract: | Transplantation with liver cells,tissue or organ remains the first-line treatment for terminal irreversible liver failure. Human embryonic stem cells-derived hepatocyte-like cells( hESC-HLCs) may represent a stable,effective and well-controlled cell source for the transplantation. To meet the quality requirements for clinical use,hESC-HLCs must possess four major quality attributes,i. e. general biological attributes,microbiology safety,biological safety and biological effectiveness,with each category comprising of a number of key quality attributes.The manufacturing process of hESC-HLCs starting from hESCs and ending with the completion of hESC-HLCs differentiation can be divided into four relatively distinct stages with each stage featured with relatively specific cell morphology,biomarkers,biological activities,and so on. In this report,we provided a comprehensive discussion on the quality requirements and key quality attributes of h ESC-HLCs with the goal of establishment of a quality evaluation system and development of relevant evaluation strategies for ensuring both safety and effectiveness of h ESC-HLCs to be used in clinical studies. |
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| Keywords: | embryonic stem cells hepatocyte-like cells quality attributes quality evaluation stage-specific differentiation |
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