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欧盟批准Alofisel治疗克罗恩病患者的复杂肛周瘘

2018-04-07 MedSci MedSci原创

Alofisel肛周瘘干细胞疗法
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TiGenix NV和武田制药公司近日宣布，欧盟委员会（EC）已批准Alofisel（Darvadstrocel，前期名称为Cx601），用于治疗成人非活动性/轻度活动性克罗恩病患者的复杂肛周瘘，这些患者往往对至少一种常规疗法或生物疗法耐受。Darvadstrocel这次获得欧盟委员会的首肯标志着首个异体干细胞疗法在欧洲范围内取得了成功。

TiGenix NV和武田制药公司近日宣布，欧盟委员会（EC）已批准Alofisel（Darvadstrocel，前期名称为Cx601），用于治疗成人非活动性/轻度活动性克罗恩病患者的复杂肛周瘘，这些患者往往对至少一种常规疗法或生物疗法耐受。Darvadstrocel这次获得欧盟委员会的首肯标志着首个异体干细胞疗法在欧洲范围内取得了成功。

在欧洲批准之前，欧洲药品管理局（EMA）的人用药品委员会（CHMP）和高级治疗委员会（CAT）一起于2017年12月对Darvadstrocel发表了积极意见。这次批准主要基于III期临床试验（ADMIRE-CD）的关键结果，该试验显示Darvadstrocel在主要疗效终点方面与对照组相比具有统计学意义上的显著性优势，后续数据表明Darvadstrocel对克罗恩病患者的难治性复杂肛周瘘具有长期缓解作用。

Alofisel是一种局部给药的异体扩增脂肪干细胞（eASCs）疗法，用于此前至少对一种常规疗法或生物疗法反应不足的成人克罗恩病患者复杂肛瘘的治疗。伦敦圣马克医院和帝国理工学院的Ailsa Hart教授称：“Alofisel为那些对当前可用疗法无反应的患者提供了一种新型且耐受性良好的干细胞疗法治疗选择，并且是迄今为止有效的治疗方案”。


原始出处：

https://www.europeanpharmaceuticalreview.com/news/74148/alofisel-perianal-fistulae/

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1764723, encodeId=48bd1e6472328, content=<a href='/topic/show?id=3cc18112590' target=_blank style='color:#2F92EE;'>#肛周瘘#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81125, encryptionId=3cc18112590, topicName=肛周瘘)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c42f37776896, createdName=12498cf9m47(暂无昵称), createdTime=Wed Dec 12 20:56:00 CST 2018, time=2018-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=305760, encodeId=433c305e6043, content=学习了.谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/10/23/557c1f19aaf5459a8405411e38903c4b.jpg, createdBy=dfc02088287, createdName=cscdliu, createdTime=Sat Apr 14 18:52:47 CST 2018, time=2018-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=304347, encodeId=ed1b30434ef7, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/01/15/8213228fe923915543544ad3da7e1c64.jpg, createdBy=6bd82014262, createdName=秀红, createdTime=Tue Apr 10 05:55:57 CST 2018, time=2018-04-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1589990, encodeId=2779158999054, content=<a href='/topic/show?id=2d1c63118e9' target=_blank style='color:#2F92EE;'>#欧盟批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63118, encryptionId=2d1c63118e9, topicName=欧盟批准)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0d617780998, createdName=chenwq14, createdTime=Mon Apr 09 08:56:00 CST 2018, time=2018-04-09, status=1, ipAttribution=)]
    2018-12-12 12498cf9m47(暂无昵称)

    #肛周瘘#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1764723, encodeId=48bd1e6472328, content=<a href='/topic/show?id=3cc18112590' target=_blank style='color:#2F92EE;'>#肛周瘘#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81125, encryptionId=3cc18112590, topicName=肛周瘘)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c42f37776896, createdName=12498cf9m47(暂无昵称), createdTime=Wed Dec 12 20:56:00 CST 2018, time=2018-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=305760, encodeId=433c305e6043, content=学习了.谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/10/23/557c1f19aaf5459a8405411e38903c4b.jpg, createdBy=dfc02088287, createdName=cscdliu, createdTime=Sat Apr 14 18:52:47 CST 2018, time=2018-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=304347, encodeId=ed1b30434ef7, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/01/15/8213228fe923915543544ad3da7e1c64.jpg, createdBy=6bd82014262, createdName=秀红, createdTime=Tue Apr 10 05:55:57 CST 2018, time=2018-04-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1589990, encodeId=2779158999054, content=<a href='/topic/show?id=2d1c63118e9' target=_blank style='color:#2F92EE;'>#欧盟批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63118, encryptionId=2d1c63118e9, topicName=欧盟批准)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0d617780998, createdName=chenwq14, createdTime=Mon Apr 09 08:56:00 CST 2018, time=2018-04-09, status=1, ipAttribution=)]
    2018-04-14 cscdliu

    学习了.谢谢

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1764723, encodeId=48bd1e6472328, content=<a href='/topic/show?id=3cc18112590' target=_blank style='color:#2F92EE;'>#肛周瘘#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81125, encryptionId=3cc18112590, topicName=肛周瘘)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c42f37776896, createdName=12498cf9m47(暂无昵称), createdTime=Wed Dec 12 20:56:00 CST 2018, time=2018-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=305760, encodeId=433c305e6043, content=学习了.谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/10/23/557c1f19aaf5459a8405411e38903c4b.jpg, createdBy=dfc02088287, createdName=cscdliu, createdTime=Sat Apr 14 18:52:47 CST 2018, time=2018-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=304347, encodeId=ed1b30434ef7, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/01/15/8213228fe923915543544ad3da7e1c64.jpg, createdBy=6bd82014262, createdName=秀红, createdTime=Tue Apr 10 05:55:57 CST 2018, time=2018-04-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1589990, encodeId=2779158999054, content=<a href='/topic/show?id=2d1c63118e9' target=_blank style='color:#2F92EE;'>#欧盟批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63118, encryptionId=2d1c63118e9, topicName=欧盟批准)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0d617780998, createdName=chenwq14, createdTime=Mon Apr 09 08:56:00 CST 2018, time=2018-04-09, status=1, ipAttribution=)]
    2018-04-10 秀红

    学习了

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1764723, encodeId=48bd1e6472328, content=<a href='/topic/show?id=3cc18112590' target=_blank style='color:#2F92EE;'>#肛周瘘#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81125, encryptionId=3cc18112590, topicName=肛周瘘)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c42f37776896, createdName=12498cf9m47(暂无昵称), createdTime=Wed Dec 12 20:56:00 CST 2018, time=2018-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=305760, encodeId=433c305e6043, content=学习了.谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/10/23/557c1f19aaf5459a8405411e38903c4b.jpg, createdBy=dfc02088287, createdName=cscdliu, createdTime=Sat Apr 14 18:52:47 CST 2018, time=2018-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=304347, encodeId=ed1b30434ef7, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/01/15/8213228fe923915543544ad3da7e1c64.jpg, createdBy=6bd82014262, createdName=秀红, createdTime=Tue Apr 10 05:55:57 CST 2018, time=2018-04-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1589990, encodeId=2779158999054, content=<a href='/topic/show?id=2d1c63118e9' target=_blank style='color:#2F92EE;'>#欧盟批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63118, encryptionId=2d1c63118e9, topicName=欧盟批准)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0d617780998, createdName=chenwq14, createdTime=Mon Apr 09 08:56:00 CST 2018, time=2018-04-09, status=1, ipAttribution=)]
    2018-04-09 chenwq14

    #欧盟批准#

    0