Article(id=1322180258955120738, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180233244038010, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1621785600000, acceptedDateStr=2021-05-24, onlineDate=1793161938655, onlineDateStr=2026-10-28, pubDate=1631635200000, pubDateStr=2021-09-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793161938655, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793161938655, creator=13701087609, updateTime=1793161938655, updator=13701087609, issue=Issue{id=1322180233244038010, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='17', pageStart='1537', pageEnd='1632', issueExtLink='null', onlineDate='null', pubDate='1631635200000', pubDateStr='2021-09-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793161932525, creator='13701087609', updateTime=1793162118166, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322181011941732619, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180233244038010, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322181011945926924, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180233244038010, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1605, endPage=1615, ext={EN=ArticleExt(id=1322180259353579619, articleId=1322180258955120738, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Establishment of a cell function evaluation method and quality control standard for hMSCs regulating Treg, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
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.
, authors=Xiao-yan HAN, Tao NA, Ting-ting WU, Bao-zhu YUAN, authorsList=Xiao-yan HAN, Tao NA, Ting-ting WU, Bao-zhu YUAN, authorCompany=null, correspAuthors=Bao-zhu YUAN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322180259886256229, articleId=1322180258955120738, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=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, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的： 建立人间充质干细胞（human mesenchymal stem cells，hMSCs）调控调节性T细胞（regulatory T cells，Treg）功能的标准评价方法和相关质量属性标准。
方法： 利用hMSCs与同种异体人外周血单个核细胞（peripheral blood mononuclear cells，PBMCs）共培养技术、流式细胞技术，和hMSCs生物学有效性质量属性研究用标准细胞株CCRC-hMSC-S1（CCRC1），建立hMSCs调控Treg功能的标准评价技术，并对不同来源hMSCs调控Treg功能的质量属性标准进行研究。
结果： 确立不同来源hMSCs促进Treg增殖的初级质量属性标准值为（47.9±23.3）%；不同研发者、不同组织来源、不同代次的hMSCs在调控Treg功能方面存在一定差异；不同培养基条件对相关功能影响也较大。
结论： 通过建立标准化评价方法，在国际上首次提出了hMSCs调控Treg功能的初级质量属性标准，而基于标准评价方法和初级质量属性标准的标准化评价体系，可量化、客观地评价不同来源、不同工艺情况下hMSCs调控Treg的功能。
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韩晓燕，女，博士，助理研究员，主要从事干细胞质量研究。联系电话：（010）53851710，E-mail：hanxiaoyan@nifdc.org.cn。
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韩晓燕，女，博士，助理研究员，主要从事干细胞质量研究。联系电话：（010）53851710，E-mail：hanxiaoyan@nifdc.org.cn。
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