Umbilical cord-derived mesenchymal stem (stromal) cells for treatment of severe sepsis: a phase 1 clinical trial
Umbilical cord-derived mesenchymal stem (stromal) cells for treatment of severe sepsis: a phase 1 clinical trial
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DOI：
10.1016/j.trsl.2018.04.006
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发表时间：
2018-09-01
影响因子：
7.8
通讯作者：
Xu, Xiang
中科院分区：
文献类型：
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作者：
He, Xiao;Ai, Shanmu;Xu, Xiang
这项1期临床试验的目的是测试单剂量同种异体脐带来源的间充质干细胞（MSC）在严重脓毒症患者中的安全性和可行性。这是一项单中心、开放标签、剂量递增的1期临床试验，在严重脓毒症患者中进行单剂量静脉内MSC。我们招募了15名患者，他们平均分为低（1 × 10（6）个细胞/kg）、中等（2 × 10（6）个细胞/kg）和高（3 × 10（6）个细胞/kg）剂量队列。主要结局包括输注相关事件和严重不良事件的发生率。次要结局包括全身终点、死亡率和炎症生物标志物。将历史病例匹配的对照组设为对照组。本研究入组了15例患者（10例男性和5例女性），中位年龄为58岁。与历史病例匹配组相比，本试验的15例患者均未发生输注相关严重事件或治疗相关不良事件，也未出现任何严重不良事件或测量的细胞因子的安全性或疗效信号。在15例严重脓毒症患者中，单次静脉输注剂量高达3 × 10（6）个细胞/kg的同种异体MSC是安全的，耐受性良好。
The aim of this phase 1 clinical trial was to test the safety and feasibility of a single dose of allogeneic umbilical cord-derived mesenchymal stem cells (MSCs) in patients with severe sepsis. This is a single-center, open-label, dose-escalation phase 1 clinical trial of a single dose of intravenous MSCs in patients with severe sepsis. We enrolled 15 patients who averagely divided into low (1 x 10(6) cells/kg), intermediate (2 x 10(6) cells/kg), and high (3 x 10(6) cells/kg) dosing cohorts. Primary outcomes included the incidence of infusion-associated events and serious adverse events. Secondary outcomes included systemic endpoints, mortality, and inflammation biologic markers. A historical case-matched comparison group was set as the control. This study enrolled 15 patients (10 male and 5 female), with a median age of 58. Compared to those in the historical, case-matched group, neither there were infusion-associated serious events or treatment-related adverse events in any of the 15 patients in this trial, nor were there any safety or efficacy signals for serious adverse events or the measured cytokines. A single intravenous infusion of allogeneic MSCs up to a dose of 3 x 10(6) cells/kg was safe and well tolerated in 15 patients with severe sepsis.