Transplantation:肝源间充质干细胞在小儿肝脏代谢性疾病中的I/II期试验

2020-06-29 MedSci原创 MedSci原创

使用干细胞技术的再生医学是一个新兴的领域,目前正在对先天性和后天性肝病进行测试。

使用干细胞技术的再生医学是一个新兴的领域,目前正在对先天性和后天性肝病进行测试。

 

这项I/II期前瞻性、开放标签、多中心、随机试验主要目的是为了评估异源人类成人肝源祖细胞(HepaStem)在尿素循环障碍(UCDs)或Crigler-Najjar(CN)综合征儿童患者移植后6个月的安全性。次要目标包括评估输注后12个月内的安全性和初步疗效。

 

将14名UCDs患者和6名CN综合征患者按体重分为3个队列,并在港内输注3个剂量的HepaStem。采用意向性治疗分析评估临床状态、门静脉血流动力学、肝脏形态学、循环抗人白细胞抗原抗体的新生检测、临床显著不良事件(AEs)和输液严重不良事件。

 

结果证实了HepaStem的总体安全性。在整个研究期间,AEs的患者月发生率为1.76,严重不良事件发生率为0.21,其中38%发生在输液后1个月内。与CN患者相比,UCD患者的事件有增加的趋势。1名患者发生了节段性左门静脉血栓,第二名患者发生了腔内局部短暂血栓。其他AEs符合导管放置、细胞输注、伴随药物、年龄和基础疾病的预期。

 

该研究导致欧洲临床试验授权在同质患者队列中进行II期研究,重复输注和中间剂量。

 

原始出处:

 

Françoise SmetsDries Dobbelaere, et al., Phase I/II Trial of Liver-derived Mesenchymal Stem Cells in Pediatric Liver-based Metabolic Disorders: A Prospective, Open Label, Multicenter, Partially Randomized, Safety Study of One Cycle of Heterologous Human Adult Liver-derived Progenitor Cells (HepaStem) in Urea Cycle Disorders and Crigler-Najjar Syndrome Patients. Transplantation. 2019 Sep;103(9):1903-1915. doi: 10.1097/TP.0000000000002605.

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    2021-11-12 湘雅科教

    已拜读,受益匪浅。

    0

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    2020-09-15 sodoo
  4. [GetPortalCommentsPageByObjectIdResponse(id=1069551, encodeId=73cb10695514a, content=已拜读,受益匪浅。, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6c905475903, createdName=湘雅科教, createdTime=Fri Nov 12 10:39:39 CST 2021, time=2021-11-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1796156, encodeId=d5db1e9615671, content=<a href='/topic/show?id=691c1e765a0' target=_blank style='color:#2F92EE;'>#Transplant#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17765, encryptionId=691c1e765a0, topicName=Transplant)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=232a2500033, createdName=1249859em38(暂无昵称), createdTime=Sat Jan 09 22:01:45 CST 2021, time=2021-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1989600, encodeId=14b41989600f6, content=<a href='/topic/show?id=5e202543023' target=_blank style='color:#2F92EE;'>#代谢性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25430, encryptionId=5e202543023, topicName=代谢性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6cc1239, createdName=sodoo, createdTime=Tue Sep 15 22:01:45 CST 2020, time=2020-09-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1947747, encodeId=f804194e7478f, content=<a href='/topic/show?id=24ef96066d' target=_blank style='color:#2F92EE;'>#II期试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9606, encryptionId=24ef96066d, topicName=II期试验)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKUdkK5dVTue7YQDvwqM1ugOuEpDZEzvXhoGClFiavehcrNAYDuPbks3MkKLPpyAEicgic80KguxwicYQ/132, createdBy=ec952500165, createdName=ms5187542471278033, createdTime=Tue May 11 15:01:45 CST 2021, time=2021-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1657341, encodeId=b05e165e3415d, content=<a href='/topic/show?id=3ca31e71903' target=_blank style='color:#2F92EE;'>#TRA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17719, encryptionId=3ca31e71903, topicName=TRA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=757b24868428, createdName=bsmagic9140, createdTime=Wed May 19 13:01:45 CST 2021, time=2021-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1815549, encodeId=df201815549cb, content=<a href='/topic/show?id=ae359e231d4' target=_blank style='color:#2F92EE;'>#间充质干细#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97231, encryptionId=ae359e231d4, topicName=间充质干细)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4b632500090, createdName=h.y200607_23674418, createdTime=Wed Nov 04 17:01:45 CST 2020, time=2020-11-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1933535, encodeId=7b911933535b0, content=<a href='/topic/show?id=809b1e7664f' target=_blank style='color:#2F92EE;'>#Transplantation#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17766, encryptionId=809b1e7664f, topicName=Transplantation)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b30d401, createdName=huangshifeng, createdTime=Wed Oct 21 15:01:45 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1789290, encodeId=6f1c1e89290d2, content=<a href='/topic/show?id=0c8814344f5' target=_blank style='color:#2F92EE;'>#plant#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14344, encryptionId=0c8814344f5, topicName=plant)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Sun Jan 31 14:01:45 CST 2021, time=2021-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1025474, encodeId=6a5b10254e4df, content=干细胞是热点,但是进入临床仍然需要时间和临床疗效验证哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=独孤立克, createdTime=Thu Jul 02 21:01:45 CST 2020, time=2020-07-02, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1069551, encodeId=73cb10695514a, content=已拜读,受益匪浅。, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6c905475903, createdName=湘雅科教, createdTime=Fri Nov 12 10:39:39 CST 2021, time=2021-11-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1796156, encodeId=d5db1e9615671, content=<a href='/topic/show?id=691c1e765a0' target=_blank style='color:#2F92EE;'>#Transplant#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17765, encryptionId=691c1e765a0, topicName=Transplant)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=232a2500033, createdName=1249859em38(暂无昵称), createdTime=Sat Jan 09 22:01:45 CST 2021, time=2021-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1989600, encodeId=14b41989600f6, content=<a href='/topic/show?id=5e202543023' target=_blank style='color:#2F92EE;'>#代谢性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25430, encryptionId=5e202543023, topicName=代谢性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6cc1239, createdName=sodoo, createdTime=Tue Sep 15 22:01:45 CST 2020, time=2020-09-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1947747, encodeId=f804194e7478f, content=<a href='/topic/show?id=24ef96066d' target=_blank style='color:#2F92EE;'>#II期试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9606, encryptionId=24ef96066d, topicName=II期试验)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKUdkK5dVTue7YQDvwqM1ugOuEpDZEzvXhoGClFiavehcrNAYDuPbks3MkKLPpyAEicgic80KguxwicYQ/132, createdBy=ec952500165, createdName=ms5187542471278033, createdTime=Tue May 11 15:01:45 CST 2021, time=2021-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1657341, encodeId=b05e165e3415d, content=<a href='/topic/show?id=3ca31e71903' target=_blank style='color:#2F92EE;'>#TRA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17719, encryptionId=3ca31e71903, topicName=TRA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=757b24868428, createdName=bsmagic9140, createdTime=Wed May 19 13:01:45 CST 2021, time=2021-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1815549, encodeId=df201815549cb, content=<a href='/topic/show?id=ae359e231d4' target=_blank style='color:#2F92EE;'>#间充质干细#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97231, encryptionId=ae359e231d4, topicName=间充质干细)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4b632500090, createdName=h.y200607_23674418, createdTime=Wed Nov 04 17:01:45 CST 2020, time=2020-11-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1933535, encodeId=7b911933535b0, content=<a href='/topic/show?id=809b1e7664f' target=_blank style='color:#2F92EE;'>#Transplantation#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17766, encryptionId=809b1e7664f, topicName=Transplantation)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b30d401, createdName=huangshifeng, createdTime=Wed Oct 21 15:01:45 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1789290, encodeId=6f1c1e89290d2, content=<a href='/topic/show?id=0c8814344f5' target=_blank style='color:#2F92EE;'>#plant#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14344, encryptionId=0c8814344f5, topicName=plant)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Sun Jan 31 14:01:45 CST 2021, time=2021-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1025474, encodeId=6a5b10254e4df, content=干细胞是热点,但是进入临床仍然需要时间和临床疗效验证哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=独孤立克, createdTime=Thu Jul 02 21:01:45 CST 2020, time=2020-07-02, status=1, ipAttribution=)]
    2021-05-19 bsmagic9140
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    2021-01-31 xuyu
  9. [GetPortalCommentsPageByObjectIdResponse(id=1069551, encodeId=73cb10695514a, content=已拜读,受益匪浅。, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6c905475903, createdName=湘雅科教, createdTime=Fri Nov 12 10:39:39 CST 2021, time=2021-11-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1796156, encodeId=d5db1e9615671, content=<a href='/topic/show?id=691c1e765a0' target=_blank style='color:#2F92EE;'>#Transplant#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17765, encryptionId=691c1e765a0, topicName=Transplant)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=232a2500033, createdName=1249859em38(暂无昵称), createdTime=Sat Jan 09 22:01:45 CST 2021, time=2021-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1989600, encodeId=14b41989600f6, content=<a href='/topic/show?id=5e202543023' target=_blank style='color:#2F92EE;'>#代谢性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25430, encryptionId=5e202543023, topicName=代谢性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6cc1239, createdName=sodoo, createdTime=Tue Sep 15 22:01:45 CST 2020, time=2020-09-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1947747, encodeId=f804194e7478f, content=<a href='/topic/show?id=24ef96066d' target=_blank style='color:#2F92EE;'>#II期试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9606, encryptionId=24ef96066d, topicName=II期试验)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKUdkK5dVTue7YQDvwqM1ugOuEpDZEzvXhoGClFiavehcrNAYDuPbks3MkKLPpyAEicgic80KguxwicYQ/132, createdBy=ec952500165, createdName=ms5187542471278033, createdTime=Tue May 11 15:01:45 CST 2021, time=2021-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1657341, encodeId=b05e165e3415d, content=<a href='/topic/show?id=3ca31e71903' target=_blank style='color:#2F92EE;'>#TRA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17719, encryptionId=3ca31e71903, topicName=TRA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=757b24868428, createdName=bsmagic9140, createdTime=Wed May 19 13:01:45 CST 2021, time=2021-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1815549, encodeId=df201815549cb, content=<a href='/topic/show?id=ae359e231d4' target=_blank style='color:#2F92EE;'>#间充质干细#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97231, encryptionId=ae359e231d4, topicName=间充质干细)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4b632500090, createdName=h.y200607_23674418, createdTime=Wed Nov 04 17:01:45 CST 2020, time=2020-11-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1933535, encodeId=7b911933535b0, content=<a href='/topic/show?id=809b1e7664f' target=_blank style='color:#2F92EE;'>#Transplantation#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17766, encryptionId=809b1e7664f, topicName=Transplantation)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b30d401, createdName=huangshifeng, createdTime=Wed Oct 21 15:01:45 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1789290, encodeId=6f1c1e89290d2, content=<a href='/topic/show?id=0c8814344f5' target=_blank style='color:#2F92EE;'>#plant#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14344, encryptionId=0c8814344f5, topicName=plant)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Sun Jan 31 14:01:45 CST 2021, time=2021-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1025474, encodeId=6a5b10254e4df, content=干细胞是热点,但是进入临床仍然需要时间和临床疗效验证哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=独孤立克, createdTime=Thu Jul 02 21:01:45 CST 2020, time=2020-07-02, status=1, ipAttribution=)]
    2020-07-02 独孤立克

    干细胞是热点,但是进入临床仍然需要时间和临床疗效验证哦

    0

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多物种空间转录组鉴定胚胎主动脉的HSC支持性分子谱。 ADM、RAMP2和SVEP1是胚胎主动脉中保守的HSC调控因子。

Open Heart:杨跃进团队发现强化他汀联合干细胞提高射血分数达12%

近期,阜外医院杨跃进团队的“强化他汀提高干细胞治疗急性心肌梗死疗效的临床研究”(STEM-AMI)在BMJ子刊在线发表。