用于缺血性心力衰竭患者的ixmyelocel- T:一个前性随机双盲试验
Amit N Patel1, Timothy D Henry2, Arshed A Quyyumi3
1University of Utah Health Care, Salt Lake City, UT, USA.
Lancet (London, England)
|April 10, 2016
概括
在心力衰竭患者中,Ixmyelocel- T细胞治疗显著降低了心脏事件. 在迄今为止最大的细胞治疗心力衰竭研究中,这种扩展的多细胞治疗改善了患者的结果.
科学领域:
- 心脏病学
- 复原医学
- 细胞治疗
背景情况:
- Ixmyelocel-T是一种扩展的多细胞疗法,来自患者自己的骨髓.
- 它涉及CD90+介质干细胞和CD45+CD14+激活的巨细胞的选择性扩张.
- 之前的试验表明,在缺血扩张性心肌病的心力衰竭患者中可能有好处.
研究的目的:
- 评估通过导管注射ixmyelocel- T 的安全性和有效性.
- 评估心力衰竭和由于缺血性扩张性心肌病导致的排泄分数减少的患者的结局.
主要方法:
- 一个随机,双盲,安慰剂控制的2B期试验 (ixCELL- DCM) 涉及126名患者.
- 患者接受了ixmyelocel- T或安慰剂,并进行了12个月的随访.
- 主要终点是死亡,心血管住院和急性不补偿性心力衰竭的非计划性访问.
主要成果:
- 与安慰剂相比,ixmyelocel- T 组的心脏事件减少了 37% (风险比为 0. 63; p=0. 0344).
- 在ixmyelocel- T组中,严重不良事件的发生率较低 (53%),而非安慰剂 (75%) (p=0. 0197).
- 这项研究包括NYHA III/ IV 类心力衰竭患者, LVEF ≤35% 不符合再血管化的条件.
结论:
- 在心力衰竭患者中,Ixmyelocel- T通过心脏输送显著降低了临床心脏事件.
- 这是迄今为止对心力衰竭患者进行的最大的细胞疗法研究.
- 这些发现表明ixmyelocel- T治疗改善了患者的治疗结果.
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