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Lancet：Ixmyelocel-T细胞疗法或将是HFrEF患者的福音

2016-04-05 Mechront 译 MedSci原创

HFrEFIxmyelocel-T细胞疗法
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美国心脏病学会年会上称，ixCELL-DCM试验2b阶段，心内膜注射ixmyelocel-T细胞治疗因缺血性扩张型心肌病导致射血分数减少的HF患者（HFrEF），可减少心脏事件的发生（与安慰剂相比）。该随机、双盲、安慰剂对照试验纳入了126名HFrEF患者，其左心室射血分数减少至35%，有植入型心律转复除颤器，不能行血管再生治疗。研究人员将其随机分为ixmyelocel-T (Vericel)组或


美国心脏病学会年会上称，ixCELL-DCM试验2b阶段，心内膜注射ixmyelocel-T细胞治疗因缺血性扩张型心肌病导致射血分数减少的HF患者（HFrEF），可减少心脏事件的发生（与安慰剂相比）。

该随机、双盲、安慰剂对照试验纳入了126名HFrEF患者，其左心室射血分数减少至35%，有植入型心律转复除颤器，不能行血管再生治疗。研究人员将其随机分为ixmyelocel-T (Vericel)组或安慰剂组，在骨髓穿刺时开始接受治疗。随访12个月，以全因死亡、CV住院或计划外门诊治疗急性代偿性HF作为主要复合终点。

ITT人群包括114名患者，符合方案集人群包括109名患者。

美国希德斯-西奈医疗中心介入心脏病和心脏病学主任Timothy D. Henry博士说：“对符合方案集人群进行有效性分析后发现，细胞疗法可减少37%的主要终点事件(RR = 0.63; 95% CI, 0.42-0.97)。事件发生率在安慰剂组和细胞治疗组分别为109.97/100人年和69.76/100人年。”

符合方案集人群进行安全性分析后发现，安慰剂组中和细胞治疗组严重不良事件发生比例分别为75%和53%(P = .0197)。

而左心室射血分数、左心室体积和纽约心脏协会心功分级或6分钟步行试验结果没有得到改善。

北卡罗莱纳夏洛特卡罗莱纳州卫生保健系统晚期心衰医学顾问Sanjeev Gulati博士说：“该研究再一次表明，细胞疗法是晚期HF患者的一个可行的选择，并且其创伤低于手术治疗，或许可以降低HF患者的死亡率和住院率。未来还需要更多更大的研究，验证这一结果。试想一下，在早期就进行细胞疗法干预，尤其是对于缺血性心肌病患者，如果MI，我们不用等到NYHA III级或IV HF后再进行干预。此外还可以将这一发现应用到疾病的预防，在HF疾病发作之前就控制好危险因素如高血压、糖尿病、高脂血症等。不过一切想象都需要得到科学证据的支持。”

原始出处：

Amit N Patel, Timothy D Henry,et al.Ixmyelocel-T for patients with ischaemic heart failure: a prospective randomised double-blind trial.Lancet.Published online April 4, 2016

Henry TD. Late-Breaking Clinical Trials V. Presented at: American College of Cardiology Scientific Session; April 2-4, 2016; Chicago.

Cell therapy reduces cardiac events in certain patients with HFrEF.Healio.April 4, 2016

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1828451, encodeId=da171828451f8, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=医者仁心, createdTime=Mon Feb 06 23:30:00 CST 2017, time=2017-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1959582, encodeId=fa6e195958256, content=<a href='/topic/show?id=dbe6445416' target=_blank style='color:#2F92EE;'>#CEL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4454, encryptionId=dbe6445416, topicName=CEL)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, createdName=维他命, createdTime=Sat May 14 10:30:00 CST 2016, time=2016-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=76341, encodeId=f763e63416f, content=干细胞领域有做头, beContent=null, objectType=article, channel=null, level=null, likeNumber=173, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5Kic7VZoYTyHkgaRHr2XRa5qF89zWgOmHCrUWcULQgLxRyiaa3nMT1CSF4E0Bm9er7UkV7oLDqN0zpd/0, createdBy=caaa1638621, createdName=1dd9cdf8m90(暂无匿称), createdTime=Thu Apr 07 23:53:00 CST 2016, time=2016-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1396174, encodeId=2e2313961e490, content=<a href='/topic/show?id=3d858e829d' target=_blank style='color:#2F92EE;'>#HFrEF#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8782, encryptionId=3d858e829d, topicName=HFrEF)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Thu Apr 07 09:30:00 CST 2016, time=2016-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1477988, encodeId=09be14e7988c4, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Thu Apr 07 09:30:00 CST 2016, time=2016-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=76041, encodeId=b5c9e604140, content=学习了，很好, beContent=null, objectType=article, channel=null, level=null, likeNumber=135, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=387d1660055, createdName=dhzzm, createdTime=Wed Apr 06 15:45:00 CST 2016, time=2016-04-06, status=1, ipAttribution=)]
    2017-02-06 医者仁心

    #Lancet#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1828451, encodeId=da171828451f8, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=医者仁心, createdTime=Mon Feb 06 23:30:00 CST 2017, time=2017-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1959582, encodeId=fa6e195958256, content=<a href='/topic/show?id=dbe6445416' target=_blank style='color:#2F92EE;'>#CEL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4454, encryptionId=dbe6445416, topicName=CEL)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, createdName=维他命, createdTime=Sat May 14 10:30:00 CST 2016, time=2016-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=76341, encodeId=f763e63416f, content=干细胞领域有做头, beContent=null, objectType=article, channel=null, level=null, likeNumber=173, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5Kic7VZoYTyHkgaRHr2XRa5qF89zWgOmHCrUWcULQgLxRyiaa3nMT1CSF4E0Bm9er7UkV7oLDqN0zpd/0, createdBy=caaa1638621, createdName=1dd9cdf8m90(暂无匿称), createdTime=Thu Apr 07 23:53:00 CST 2016, time=2016-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1396174, encodeId=2e2313961e490, content=<a href='/topic/show?id=3d858e829d' target=_blank style='color:#2F92EE;'>#HFrEF#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8782, encryptionId=3d858e829d, topicName=HFrEF)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Thu Apr 07 09:30:00 CST 2016, time=2016-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1477988, encodeId=09be14e7988c4, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Thu Apr 07 09:30:00 CST 2016, time=2016-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=76041, encodeId=b5c9e604140, content=学习了，很好, beContent=null, objectType=article, channel=null, level=null, likeNumber=135, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=387d1660055, createdName=dhzzm, createdTime=Wed Apr 06 15:45:00 CST 2016, time=2016-04-06, status=1, ipAttribution=)]
    2016-05-14 维他命

    #CEL#

    0

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    2016-04-07 1dd9cdf8m90(暂无匿称)

    干细胞领域有做头

    0

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    2016-04-07 智者为医08

    #HFrEF#

    0

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    2016-04-07 124984edm24暂无昵称

    #T细胞疗法#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1828451, encodeId=da171828451f8, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=医者仁心, createdTime=Mon Feb 06 23:30:00 CST 2017, time=2017-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1959582, encodeId=fa6e195958256, content=<a href='/topic/show?id=dbe6445416' target=_blank style='color:#2F92EE;'>#CEL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4454, encryptionId=dbe6445416, topicName=CEL)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, createdName=维他命, createdTime=Sat May 14 10:30:00 CST 2016, time=2016-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=76341, encodeId=f763e63416f, content=干细胞领域有做头, beContent=null, objectType=article, channel=null, level=null, likeNumber=173, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5Kic7VZoYTyHkgaRHr2XRa5qF89zWgOmHCrUWcULQgLxRyiaa3nMT1CSF4E0Bm9er7UkV7oLDqN0zpd/0, createdBy=caaa1638621, createdName=1dd9cdf8m90(暂无匿称), createdTime=Thu Apr 07 23:53:00 CST 2016, time=2016-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1396174, encodeId=2e2313961e490, content=<a href='/topic/show?id=3d858e829d' target=_blank style='color:#2F92EE;'>#HFrEF#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8782, encryptionId=3d858e829d, topicName=HFrEF)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Thu Apr 07 09:30:00 CST 2016, time=2016-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1477988, encodeId=09be14e7988c4, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Thu Apr 07 09:30:00 CST 2016, time=2016-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=76041, encodeId=b5c9e604140, content=学习了，很好, beContent=null, objectType=article, channel=null, level=null, likeNumber=135, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=387d1660055, createdName=dhzzm, createdTime=Wed Apr 06 15:45:00 CST 2016, time=2016-04-06, status=1, ipAttribution=)]
    2016-04-06 dhzzm

    学习了，很好

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