Article(id=1322906847442763813, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887806737825858, 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=1630339200000, acceptedDateStr=2021-08-31, onlineDate=1793335170850, onlineDateStr=2026-10-30, pubDate=1634227200000, pubDateStr=2021-10-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793335170850, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793335170850, creator=13701087609, updateTime=1793335170850, updator=13701087609, issue=Issue{id=1322887806737825858, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='19', pageStart='1729', pageEnd='1824', issueExtLink='null', onlineDate='null', pubDate='1634227200000', pubDateStr='2021-10-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793330631192, creator='13701087609', updateTime=1793337389212, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322916151994495727, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887806737825858, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322916151994495728, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887806737825858, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1746, endPage=1751, ext={EN=ArticleExt(id=1322906847618924582, articleId=1322906847442763813, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=The quality issues in quality review for stem cell clinical research and its primary analysis, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Since the administration of “Measures for the Administration of Stem Cell Clinical Research (for Trial Implementation)” in 2015, Cell Collection and Research Center of Institutes for Biological Products Control, National Institutes for Food and Drug Control has undertaken the task of reviewing the quality of stem cell preparations used in clinical research. During the technical communication with stem cell preparation developers and data reviewprocess, some problems were found in cell preparation technique and quality standards of formulation. It was also found that there were a number of non-compliance with the safety and effectiveness test of stem cells. This paper briefly summarizes and analyzes the problems found in the stem cell quality review in our center, so as to provide valuable insights into the research, manufacture, quality control and clinical use of stem cell products.

, authors=Ke-hua ZHANG, Tao NA, Xiao-yan HAN, Ting-ting WU, Li-xia ZHANG, Chun-cui JIA, Xiang-he YUAN, Jian-ping FENG, Nan XIANG, Shu-fang MENG, authorsList=Ke-hua ZHANG, Tao NA, Xiao-yan HAN, Ting-ting WU, Li-xia ZHANG, Chun-cui JIA, Xiang-he YUAN, Jian-ping FENG, Nan XIANG, Shu-fang MENG, authorCompany=null, correspAuthors=Shu-fang MENG, 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=1322906847929303079, articleId=1322906847442763813, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=干细胞临床研究质量复核中发现的问题及初步分析, columnId=1236330552693944345, journalTitle=中国新药杂志, columnName=生物医药前沿, runingTitle=null, highlight=null, articleAbstract=

自2015年《干细胞临床研究管理办法（试行）》颁布以来，中国食品药品检定研究院生物制品检定所细胞资源保藏研究中心承接了大量的干细胞临床研究细胞制剂质量复核工作，在与干细胞制剂研发机构技术沟通、资料审阅过程中发现了若干在细胞制备工艺、制剂质量标准中存在的问题，在质量复核中也发现在干细胞安全性和干细胞特性检测方面存在多项不符合规定或异常的情况。本文总结了当前本中心在干细胞质量复核中发现的各种情况并进行了简要分析，为干细胞制剂研发生产、质量控制以及临床使用提供参考。

, authors=张可华, 纳涛, 韩晓燕, 吴婷婷, 张丽霞, 贾春翠, 袁翔鹤, 冯建萍, 项楠, 孟淑芳, authorsList=张可华, 纳涛, 韩晓燕, 吴婷婷, 张丽霞, 贾春翠, 袁翔鹤, 冯建萍, 项楠, 孟淑芳, authorCompany=null, correspAuthors=孟淑芳, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=OZiGMQHxO7WpGsLVaL8i4A==, magXml=6kj+fo+4AriQLZIwHzjrHw==, pdfUrl=null, pdf=7mDRmswY4QKyIieQBP8B+Q==, pdfFileSize=1545493, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=PIQ2Sdf1diAlSFqiUdrKJA==, mapNumber=null, fund=null)}, authors=[Author(id=1322906848235487276, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906847442763813, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=zhangkehua@nifdc.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322906848336150574, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906847442763813, authorId=1322906848235487276, language=EN, stringName=Ke-hua ZHANG, firstName=Ke-hua, middleName=null, lastName=ZHANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Cell Collection and Research Center, Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Institutes for Biological Products Control, National Institutes for Food and Drug Control, Beijing 102629, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322906848420036655, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906847442763813, authorId=1322906848235487276, language=CN, stringName=张可华, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=中国食品药品检定研究院生物制品检定所细胞资源保藏研究中心，卫生部生物技术产品检定方法及其标准化重点实验室，北京　102629, bio={"content":"

张可华，男，副研究员，主要从事干细胞质量研究。联系电话：（010）53851708，E-mail：zhangkehua@nifdc.org.cn。

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张可华，男，副研究员，主要从事干细胞质量研究。联系电话：（010）53851708，E-mail：zhangkehua@nifdc.org.cn。

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