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Establishment of a cell function evaluation method and quality control standard for hMSCs regulating Treg
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Xiao-yan HAN, Tao NA, Ting-ting WU, Bao-zhu YUAN
Chinese Journal of New Drugs | 2021, 30(17) : 1605 - 1615
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收藏切换
Chinese Journal of New Drugs | 2021, 30(17): 1605-1615
Establishment of a cell function evaluation method and quality control standard for hMSCs regulating Treg
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Xiao-yan HAN, Tao NA, Ting-ting WU, Bao-zhu YUAN
Affiliations
  • Cell Collection and Research Center, Institutes for Biological Products Control, National Institutes for Food and Drug Control, Beijing 100050, China
Published: 2021-09-15
Outline
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Objective:

To establish a standard quality assessment method and a quality attribute standard of human mesenchymal stem cells (hMSCs) regulating the regulatory T cells (Treg).

Methods:

Based on co-culturing of hMSCs with allogenic human peripheral blood mononuclear cells (PBMCs), flow cytometry, and a reference cell line CCRC-hMSC-S1 (CCRC1), a standard evaluation technique for hMSCs regulating Treg was established, which was further applied in quality attribute standard of hMSCs of various origins.

Results:

A percentage of (47.9±23.3)% was established as the preliminary standard quality attribute value of hMSCs regulating Treg. The differences in manufacturing processes, cell growth media, cell passage numbers, and tissue origins significantly affected the quality of hMSCs regulating Treg.

Conclusion:

Through the development of the standardized evaluation technique, a preliminary quality attribute value of hMSCs regulating Treg function was established for the first time. The combination of the standardized assessment technique and the quality attribute value proved to be effective for quantitative evaluation of the quality of hMSCs and of great value in guiding the development of hMSCs products.

human mesenchymal stem cells (hMSCs)  /  regulatory T cells (Treg)  /  quality evaluation  /  assessment technique  /  quality attribute value
韩晓燕, 纳涛, 吴婷婷, 袁宝珠. 人间充质干细胞调控Treg细胞功能评价方法和质量标准的研究. 中国新药杂志, 2021 , 30 (17) : 1605 -1615 .
Xiao-yan HAN, Tao NA, Ting-ting WU, Bao-zhu YUAN. Establishment of a cell function evaluation method and quality control standard for hMSCs regulating Treg[J]. Chinese Journal of New Drugs, 2021 , 30 (17) : 1605 -1615 .
Year 2021 volume 30 Issue 17
38
10
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  • Online Date:2026-10-28
  • Published:2021-09-15
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  • Accepted:2021-05-24
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    Cell Collection and Research Center, Institutes for Biological Products Control, National Institutes for Food and Drug Control, Beijing 100050, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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