Rationale and design for TIME: A phase II, randomized, double-blind, placebo-controlled pilot trial evaluating the safety and effect of timing of administration of bone marrow mononuclear cells after acute myocardial infarction
Rationale and design for TIME: A phase II, randomized, double-blind, placebo-controlled pilot trial evaluating the safety and effect of timing of administration of bone marrow mononuclear cells after acute myocardial infarction
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DOI：
10.1016/j.ahj.2009.06.009
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发表时间：
2009-09-01
影响因子：
4.8
通讯作者：
Simari, Robert D.
中科院分区：
文献类型：
--
作者：
Traverse, Jay H.;Henry, Timothy D.;Simari, Robert D.
一些先前的研究已经证明，自体骨髓来源的单核细胞（BMMNC）的管理，改善急性心肌梗死（AMI）后的患者的心功能。然而，尚未在临床试验中研究最佳给药时间。心血管细胞治疗研究网络由国家心脏，肺和血液研究所开发和资助，以解决细胞递送时间等重要问题，并加速使用基于细胞的疗法的研究。TIME试验是一项随机、II期、双盲、安慰剂对照的临床试验。心血管细胞治疗研究网络的5个成员临床研究中心将招募120名合格的中大型前壁AMI患者，这些患者已成功接受左前降支冠状动脉经皮冠状动脉介入治疗，左心室（LV）射血分数
Several previous studies have demonstrated that administration of autologous bone marrow-derived mononuclear cells (BMMNCs) improves cardiac function in patients after acute myocardial infarction (AMI). However, optimum timing of administration has not been investigated in a clinical trial. The Cardiovascular Cell Therapy Research Network was developed and funded by the National Heart, Lung, and Blood Institute to address important questions such as timing of cell delivery and to accelerate research in the use of cell-based therapies. The TIME trial is a randomized, phase II, double-blind, placebo-controlled clinical trial. The 5 member clinical sites of the Cardiovascular Cell Therapy Research Network will enroll 120 eligible patients with moderate-to-large anterior AMIs who have undergone successful percutaneous coronary intervention of the left anterior descending coronary artery and have a left ventricular (LV) ejection fraction