Intravenous Allogeneic Mesenchymal Stem Cells for Nonischemic Cardiomyopathy Safety and Efficacy Results of a Phase II-A Randomized Trial
Intravenous Allogeneic Mesenchymal Stem Cells for Nonischemic Cardiomyopathy Safety and Efficacy Results of a Phase II-A Randomized Trial
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DOI：
10.1161/circresaha.116.309717
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发表时间：
2017-01-20
影响因子：
20.1
通讯作者：
Gheorghiade, Mihai
中科院分区：
文献类型：
--
作者：
Butler, Javed;Epstein, Stephen E.;Gheorghiade, Mihai
基本原理：间充质干细胞（MSC）治疗心力衰竭的潜在益处可能与旁分泌特性和全身效应有关，包括抗炎活性。如果这一假设是有效的，静脉注射间充质干细胞应该改善心力衰竭的结果，在心力衰竭中，过度的慢性炎症可能发挥关键作用。目的：评估静脉注射缺血耐受间充质干细胞（itMSCs）在非缺血性心肌病患者中的安全性和初步疗效。这是一项单盲、安慰剂对照、交叉、随机的II期-a期试验，在左心室射血分数为100%的非缺血性心肌病患者中进行
Rationale: Potential benefits of mesenchymal stem cell (MSC) therapy in heart failure may be related to paracrine properties and systemic effects, including anti-inflammatory activities. If this hypothesis is valid, intravenous administration of MSCs should improve outcomes in heart failure, an entity in which excessive chronic inflammation may play a pivotal role.Objective: To assess the safety and preliminary efficacy of intravenously administered ischemia-tolerant MSCs (itMSCs) in patients with nonischemic cardiomyopathy.Methods and Results: This was a single-blind, placebo-controlled, crossover, randomized phase II-a trial of nonischemic cardiomyopathy patients with left ventricular ejection fraction