Article(id=1322906807240373166, 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=1621526400000, acceptedDateStr=2021-05-21, onlineDate=1793335161265, onlineDateStr=2026-10-30, pubDate=1634227200000, pubDateStr=2021-10-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793335161265, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793335161265, creator=13701087609, updateTime=1793335161265, 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=1819, endPage=1824, ext={EN=ArticleExt(id=1322906807391368111, articleId=1322906807240373166, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Risk assessment of tumorigenicity and oncogenicity of cell therapy products, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Cell therapy products (CTPs) have the potential of tumor formation risks, i.e., tumorigenicity, oncogenicity and tumor-enhancement. Since the final stem cell therapy products derived from human embryonic stem cells and human induced pluripotent stem cells may contain undifferentiated hPSCs, malignant transformed cells/mutations and genetic instability, they have the highest risk of tumorigenicity. Tumorigenicity and oncogenicity risk of CTPs may be largely increased in genetically modified stem cells, that express foreign genes (such as various growth factors), as well as the oncogene activated by insertion mutations of genetically modified viral vectors (such as retroviruses and lentiviruses). While terminally differentiated somatic cell products have lower risk of tumorigenicity. During recent years, increasing number of cell therapy products have entered the clinical application, the tumor formation risk of which is a safety issue that is concerned by product developers and regulatory authorities. This article introduces the concepts of tumorigenicity, oncogenicity and tumor-enhancement of CTPs, providing a comprehensive overview of the current evaluation methods in vitro and in vivo, as well as the general considerations for risk assessment of tumorigenicity and oncogenicity of CTPs.

, authors=Zhe QU, Zhi LIN, Gui-tao HUO, Tian-tian HOU, Yan-wei YANG, Di ZHANG, Xing-chao GENG, Bo LI, Yan HUO, authorsList=Zhe QU, Zhi LIN, Gui-tao HUO, Tian-tian HOU, Yan-wei YANG, Di ZHANG, Xing-chao GENG, Bo LI, Yan HUO, authorCompany=null, correspAuthors=Yan HUO, 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=1322906807622054832, articleId=1322906807240373166, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=细胞治疗产品的成瘤性和致瘤性风险评价, columnId=1236331161786569054, journalTitle=中国新药杂志, columnName=重大新药创制专项巡礼, runingTitle=null, highlight=null, articleAbstract=

细胞治疗产品（cell therapy products，CTPs）具有潜在的肿瘤形成风险，即成瘤性、致瘤性和促瘤性。来自于人胚胎干细胞（human embryonic stem cells，hESCs）和人诱导多能干细胞（human induced pluripotent stem cells，hiPSCs）的干细胞终产品中，由于可能存在未分化的干细胞残留、恶性转化细胞/突变和遗传不稳定性，其成瘤性风险最高。通过基因修饰的干细胞由于表达外源基因（如各种生长因子）以及基因修饰病毒载体（如逆转录病毒和慢病毒）的插入突变造成的致癌基因活化，也会增加CTPs的成瘤性和致瘤性风险。而终末分化的体细胞产品成瘤性风险相对较低。近年来，越来越多种类的细胞治疗产品进入临床应用，其肿瘤形成风险是产品研发者和监管当局都十分关注的安全性问题。本文介绍了细胞治疗产品可能存在的成瘤性、致瘤性和促瘤性风险概念，较全面地概述了目前对细胞治疗产品潜在肿瘤形成风险的体内外评价方法和对产品成瘤性和致瘤性风险评价的一般考虑。

, authors=屈哲, 林志, 霍桂桃, 侯田田, 杨艳伟, 张頔, 耿兴超, 李波, 霍艳, authorsList=屈哲, 林志, 霍桂桃, 侯田田, 杨艳伟, 张頔, 耿兴超, 李波, 霍艳, authorCompany=null, correspAuthors=霍艳, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=Ar55Fwuz9qYzf2BEBzE/XA==, magXml=qkHnB9I0nSB/VNI4vfAMfw==, pdfUrl=null, pdf=g+T6h59V5n/Yd7BkaVpkGA==, pdfFileSize=998323, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=x8V6cFPuwEiFvCTiRcp5Lw==, mapNumber=null, fund=null)}, authors=[Author(id=1322906808003736501, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906807240373166, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=quzhe@nifdc.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322906808108594103, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906807240373166, authorId=1322906808003736501, language=EN, stringName=Zhe QU, firstName=Zhe, middleName=null, lastName=QU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Beijing Key Laboratory for Safety Evaluation of Drugs, National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing 100176, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322906808423166904, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906807240373166, authorId=1322906808003736501, language=CN, stringName=屈哲, 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国家药物安全评价监测中心，药物非临床安全评价研究北京市重点实验室，北京　100176, bio={"content":"

屈哲，女，副研究员，主要从事药物非临床安全性评价研究工作。联系电话：（010）67872233-8210，E-mail：quzhe@nifdc.org.cn。

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屈哲，女，副研究员，主要从事药物非临床安全性评价研究工作。联系电话：（010）67872233-8210，E-mail：quzhe@nifdc.org.cn。

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