Results of a phase 1, randomized, double-blind, placebo-controlled trial of bone marrow mononuclear stem cell administration in patients following ST-elevation myocardial infarction.
Results of a phase 1, randomized, double-blind, placebo-controlled trial of bone marrow mononuclear stem cell administration in patients following ST-elevation myocardial infarction.
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DOI：
10.1016/j.ahj.2010.06.009
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发表时间：
2010-09
影响因子：
4.8
通讯作者：
Henry, Timothy D.
中科院分区：
文献类型：
--
作者：
Traverse, Jay H.;McKenna, David H.;Harvey, Karen;Jorgenso, Beth C.;Olson, Rachel E.;Bostrom, Nancy;Kadidlo, Diane;Lesser, John R.;Jagadeesan, Vikrant;Garberich, Ross;Henry, Timothy D.
来自欧洲的初步临床试验表明，应用骨髓来源的单个核细胞(BMCs)可以改善ST段抬高心肌梗死(STEMI)患者的左心功能。然而，在美国进行的试验结果尚未公布。我们开展了一项1期随机、安慰剂对照、双盲试验，利用心脏磁共振(CMRI)研究STEMI后患者应用BMC对左心功能恢复的影响。在冠状动脉左前降支首次血管成形术和支架置入术(PCI)成功3-10天后，40名有中到大型前壁STEMI的患者被随机分为1亿个冠状动脉内骨髓细胞和安慰剂对照组。BMC给药是在高危人群中安全进行的，MACE发生率最低，所有患者到目前为止都还活着。BMC组的左心室射血分数(LVEF)从基线的49.0±9.5%增加到6个月时的55.2±9.8%(p<；0.05)，与安慰剂组(48.6±8.5%到57.0±13.4%，p<；0.05)无差异。BMC组6个月时左室舒张末期容量(LVEDV)减少4ml/m2，而安慰剂组显著增加(17ml/m2，p<；0.01)。这项来自美国的第一阶段研究证实了在STEMI患者中使用BMC的持续安全性。细胞治疗组与安慰剂组6个月时CMRI对左心室射血分数的改善无差异。6个月时，BMC给药对LV重塑有良好效果。
Initial clinical trials from Europe have demonstrated that the administration of bone marrow-derived mononuclear cells (BMCs) may improve left-ventricular (LV) function in patients following ST-elevation myocardial infarction (STEMI). However, results from trials performed in the United States have not yet been presented. We developed a Phase 1, randomized, placebo-controlled, double-blind trial to investigate the effects of BMC administration in patients following STEMI on recovery of LV function using cardiac MRI (cMRI). Forty patients with moderate to large anterior STEMIs were randomized to 100 million intracoronary BMCs vs placebo 3 to 10 days following successful primary angioplasty and stenting (PCI) of the left-anterior descending coronary artery. BMC administration was safely performed in a high-risk cohort with minimal MACE rates and all patients remain alive to date. LV ejection fraction (LVEF) increased from 49.0±9.5% at baseline to 55.2±9.8% at 6 months by cMRI in the BMC group (p < 0.05) that was not different from the increase in the placebo group (48.6 ± 8.5% to 57.0 ± 13.4%, p<0.05). LV end-diastolic volume (LVEDV) decreased by 4 ml/m2 in the BMC group at 6 months but increased significantly in the placebo group (17 ml/m2, p < 0.01). This Phase 1 study from the United States confirms the ongoing safety profile of BMC administration in patients following STEMI. The improvement in LVEF at 6 months by cMRI in the cell therapy group was not different than the placebo group. However, BMC administration had a favorable effect on LV remodeling at 6 months.
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影响因子：
4.8
作者：
Traverse, Jay H.;Henry, Timothy D.;Simari, Robert D.
通讯作者：
Simari, Robert D.
影响因子：
168.9
作者：
Janssens, S;Dubois, C;Van de Werf, F
通讯作者：
Van de Werf, F
影响因子：
158.5
作者：
Schaechinger, Volker;Erbs, Sandra;Zeiher, Andreas M.
通讯作者：
Zeiher, Andreas M.
影响因子：
39.3
作者：
Tossios, Paschalis;Krausgrill, Benjamin;Muelller-Ehmsen, Jochen
通讯作者：
Muelller-Ehmsen, Jochen
影响因子：
24
作者：
Lipinski, Michael J.;Biondi-Zoccai, Giuseppe G. L.;Vetrovec, George W.
通讯作者：
Vetrovec, George W.