Rationale and Design of the SENECA (StEm cell iNjECtion in cAncer survivors) Trial
Rationale and Design of the SENECA (StEm cell iNjECtion in cAncer survivors) Trial
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DOI：
10.1016/j.ahj.2018.02.009
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发表时间：
2018-07-01
影响因子：
4.8
通讯作者：
Simari, Robert D.
中科院分区：
文献类型：
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作者：
Bolli, Roberto;Hare, Joshua M.;Simari, Robert D.
目的：SENECA（癌症幸存者干细胞注射）是一项 I 期、随机、双盲、安慰剂对照研究，旨在评估在蒽环类药物诱发的心肌病 (AIC) 受试者中经心内膜输送同种异体间充质基质细胞 (alloMSC) 的安全性和可行性。背景：AIC 是一种无法治愈且通常致命的综合征，其预后比缺血性心肌病更差或非缺血性心肌病。最近，间充质干细胞的细胞疗法已成为修复受损心肌的一种有前景的新方法。 方法：研究人群为 36 名诊断为 AIC、左心室 (LV) 射血分数的癌症幸存者
Objectives: SENECA (StEm cell iNjECtion in cAncer survivors) is a phase I, randomized, double-blind, placebo-controlled study to evaluate the safety and feasibility of delivering allogeneic mesenchymal stromal cells (alloMSCs) transendocardially in subjects with anthracycline-induced cardiomyopathy (AIC).Background: AIC is an incurable and often fatal syndrome, with a prognosis worse than that of ischemic or nonischemic cardiomyopathy. Recently, cell therapy with MSCs has emerged as a promising new approach to repair damaged myocardium.Methods: The study population is 36 cancer survivors with a diagnosis of AIC, left ventricular (LV) ejection fraction