Safety and Efficacy of Intracoronary Infusion of Allogeneic Human Cardiac Stem Cells in Patients With ST-Segment Elevation Myocardial Infarction and Left Ventricular Dysfunction: A Multicenter Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

Fernandez-Aviles Francisco; Sanz-Ruiz Ricardo; Bogaert Jan; Casado Plasencia Ana; Gilaberte Inmaculada; Belmans Ann; Eugenia Fernandez-Santos Maria; Charron Dominique; Mulet Miguel; Yotti Raquel; Palacios Itziar; Luque Manuel; Sadaba Rafael; Alberto San Roman J.; Larman Mariano; Sanchez Pedro L.; Sanchis Juan; Jimenez Manuel F.; Claus Piet; Al-Daccak Reem; Lombardo Eleuterio; Luis Abad Jose; DelaRosa Olga; Corcostegui Lucia; Bermejo Javier; Janssens Stefan

首页> 外文期刊>Circulation research: a journal of the American Heart Association >Safety and Efficacy of Intracoronary Infusion of Allogeneic Human Cardiac Stem Cells in Patients With ST-Segment Elevation Myocardial Infarction and Left Ventricular Dysfunction: A Multicenter Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

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Safety and Efficacy of Intracoronary Infusion of Allogeneic Human Cardiac Stem Cells in Patients With ST-Segment Elevation Myocardial Infarction and Left Ventricular Dysfunction: A Multicenter Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

机译：同种异体人体心脏干细胞患者在ST段抬高心肌梗死和左心室功能障碍患者中输注同种异体人心脏干细胞的安全性和有效性：多中心随机，双盲和安慰剂对照临床试验

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摘要

Rationale: Allogeneic cardiac stem cells (AlloCSC-01) have shown protective, immunoregulatory, and regenerative properties with a robust safety profile in large animal models of heart disease.

机译：基本原理：同种异体心脏干细胞（AlloCSC-01）显示了在心脏病大型动物模型中具有稳健的安全性的保护性，免疫调节和再生性能。

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来源
《Circulation research: a journal of the American Heart Association》 |2018年第5期|共11页
作者
Fernandez-Aviles Francisco; Sanz-Ruiz Ricardo; Bogaert Jan; Casado Plasencia Ana; Gilaberte Inmaculada; Belmans Ann; Eugenia Fernandez-Santos Maria; Charron Dominique; Mulet Miguel; Yotti Raquel; Palacios Itziar; Luque Manuel; Sadaba Rafael; Alberto San Roman J.; Larman Mariano; Sanchez Pedro L.; Sanchis Juan; Jimenez Manuel F.; Claus Piet; Al-Daccak Reem; Lombardo Eleuterio; Luis Abad Jose; DelaRosa Olga; Corcostegui Lucia; Bermejo Javier; Janssens Stefan;
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作者单位

Inst Salud Carlos III CIBERCV Madrid Spain;

Univ Complutense Inst Invest Sanitaria Gregorio Maranon Hosp Gen Univ Gregorio Maranon Dept;

Univ Complutense Inst Invest Sanitaria Gregorio Maranon Hosp Gen Univ Gregorio Maranon Dept;

Coretherapix SLU Tigenix Grp Madrid Madrid Spain;

Univ Hosp Dept Cardiovasc Med Leuven Belgium;

Univ Complutense Inst Invest Sanitaria Gregorio Maranon Hosp Gen Univ Gregorio Maranon Dept;

Hop St Louis HLA &

Med HLA MED Paris France;

Coretherapix SLU Tigenix Grp Madrid Madrid Spain;

Univ Complutense Inst Invest Sanitaria Gregorio Maranon Hosp Gen Univ Gregorio Maranon Dept;

Coretherapix SLU Tigenix Grp Madrid Madrid Spain;

Coretherapix SLU Tigenix Grp Madrid Madrid Spain;

Complejo Hosp Navarra Dept Cardiac Surg Pamplona Spain;

Inst Salud Carlos III CIBERCV Madrid Spain;

Policlin Guipuzcoa Dept Cardiol San Sebastian Spain;

Inst Salud Carlos III CIBERCV Madrid Spain;

Inst Salud Carlos III CIBERCV Madrid Spain;

Inst Salud Carlos III CIBERCV Madrid Spain;

Univ Hosp Dept Cardiovasc Med Leuven Belgium;

Hop St Louis HLA &

Med HLA MED Paris France;

Coretherapix SLU Tigenix Grp Madrid Madrid Spain;

Coretherapix SLU Tigenix Grp Madrid Madrid Spain;

Coretherapix SLU Tigenix Grp Madrid Madrid Spain;

Coretherapix SLU Tigenix Grp Madrid Madrid Spain;

Univ Complutense Inst Invest Sanitaria Gregorio Maranon Hosp Gen Univ Gregorio Maranon Dept;

Univ Hosp Dept Cardiovasc Med Leuven Belgium;

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正文语种 eng
中图分类心脏、血管（循环系）疾病;
关键词
acute myocardial infarction; allogeneic stem cell therapy; cardiac stem cells; heart failure; ventricular remodeling;

机译：急性心肌梗死;同种异体干细胞疗法;心脏干细胞;心力衰竭;心室重塑;

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1. Safety and Efficacy of Intracoronary Infusion of Allogeneic Human Cardiac Stem Cells in Patients With ST-Segment Elevation Myocardial Infarction and Left Ventricular Dysfunction: A Multicenter Randomized, Double-Blind, and Placebo-Controlled Clinical Trial [J] . Fernandez-Aviles Francisco, Sanz-Ruiz Ricardo, Bogaert Jan, Circulation research: a journal of the American Heart Association . 2018,第5期

机译：同种异体人体心脏干细胞患者在ST段抬高心肌梗死和左心室功能障碍患者中输注同种异体人心脏干细胞的安全性和有效性：多中心随机，双盲和安慰剂对照临床试验
2. A randomized, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of intracoronary application of a novel bioabsorbable cardiac matrix for the prevention of ventricular remodeling after large ST-segment elevation myocardial infarction: Rationale and design of the PRESERVATION I trial [J] . Rao Sunil V., Zeymer Uwe, Douglas Pamela S., The American heart journal . 2015,第5期

机译：一项随机，双盲，安慰剂对照试验，评估冠状动脉内应用新型生物可吸收心脏基质预防大型ST段抬高型心肌梗塞后心室重构的安全性和有效性：PRESASERVICE I试验的原理和设计
3. PreSERVE-AMI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Intracoronary Infusion of Autologous CD34+Cells in Patients With Left Ventricular Dysfunction Post STEMI [J] . Quyyumi Arshed A., Vasquez Alejandro, Klapholz Marc, Circulation: An Official Journal of the American Heart Association . 2014,第23期

机译：PreSERVE-AMI：STEMI后左心室功能不全患者冠状动脉内自体CD34 +细胞输注的随机，双盲，安慰剂对照临床试验
4. Right ventricular ischemic injury in patients with acute ST-segment elevation myocardial infarction. Characterization with cardiac magnetic resonance. [C] . Bonanad C, Lopez-Lereu MP, García S, International Congress on Coronary Artery Disease . 2011

机译：急性ST段升高心肌梗死患者右心室缺血性损伤。用心脏磁共振表征。
5. The prognosis and outcomes of patients with a ST-segment elevation myocardial infarction and the biochemical and clinical inflammatory response [D] . van Diepen, Sean frederick 2013

机译：ST段升高心肌梗死患者的预后和结果及生物化学和临床炎症反应
6. PreSERVE-AMI: A Randomized Double-Blind Placebo-Controlled Clinical Trial of Intracoronary Administration of Autologous CD34+ Cells in Patients with Left Ventricular Dysfunction Post STEMI [O] . Arshed A. Quyyumi, Alejandro Vasquez, Dean Kereiakes, -1

机译：PreSERVE-AMI：STEMI后左心功能不全患者冠状动脉内自体CD34 +细胞的随机双盲安慰剂对照临床试验
7. MODERATED EPOSTERS1385Longitudinal strain assessment in dilated cardiomyopathy patients using a novel accelerated DENSE sequence1407Simultaneous T1 and T2 cardiac quantification with CABIRIA: initial clinical experience1423Head-to-head comparison of acceleration algorithms in 4-dimensional flow CMR1502Left ventricular function and size evaluated by hybrid cardiac positron emission tomography-magnetic resonance: Intraindividual comparison of left ventricular ejection fraction and ventricular volumes derived by two modalities1510Left Atrium assessed by Cardiovascular Magnetic Resonance at 1.5 and 3 Tesla – age and gender effects1514Comparison of Free Breathing Cardiac MRI Radial technique to the Standard Multi breath-hold cine SSFP CMR technique for the assessment of LV Volumes and Function1536Self-navigated free-breathing isotropic 3D whole heart phase sensitive inversion recovery magnetic resonance without navigator for detection of myocardial infarction1547Assessment of Right Ventricular Strain Using Myocardial Deformation Recovery Semi Automated Technique: Initial Experience and Normal Values1586Tissue tracking myocardial deformation analysis and prediction of left ventricular remodeling in acute myocardial infarction1589Investigating strategies for optimal 31P MRS clinical cardiac at 3T: Initial Results1620Quantitative Criteria for the Diagnosis of the Congenital Absence of Pericardium by Cardiac Magnetic Resonance1632Widespread tissue injury during acute myocardial infarction: evidence from advanced CMR relaxometry1322Computed tomography coronary angiography verSus sTRess cArdiac magneTic rEsonance for the manaGement of sYmptomatic revascularized patients: a cost effectiveness study (STRATEGY study)1339Comparison of low- versus high-dose of gadobutrol for late gadolinium enhancement imaging at 1.5 Tesla: a clinical feasibility study1347Multi-parametric Cardiac Magnetic Resonance for Prediction of Cardiac Complications in Thalassemia Intermedia: a Prospective Multicenter Study1461Prognostic value of Cardiovascular Magnetic Resonance derived indexes of myocardial fibrosis in heart transplant recipients1523The role of CMR in the acute phase of hospitalization: changing paradigms1542Preoperative CMR-based score predict ventricular response after surgical left ventricular reconstruction in ischemic heart failure patients1555Excellent response rate to cardiac resynchronization therapy guided with magnetic resonance imaging1626The ECG as a predictor of arrhythmogenic substrate on Cardiac Magnetic Resonance Imaging in patients undergoing ablation for premature ventricular contractions1649Comparison of T1-mapping at 3.0T CMR and angiographic APPROACH score for area at risk assessment in ST-segment elevation myocardial infarction1340Pathological correlates of left bundle branch disease in patients with non-ischemic cardiomyopathy: a cardiovascular magnetic resonance study1342Myocardial remodelling and fibrosis in nonischaemic dilated cardiomyopathy: insights from cardiovascular magnetic resonance1411The association between fibrosis and contractile dysfunction in hypertrophic cardiomyopathy assessed by cardiovascular magnetic resonance1622Persistent myocardial inflammation due to intramyocardial haemorrhage in reperfused STEMI as a precursor to adverse LV remodelling - insights from multi-parametric mapping1566Semiquantitative analysis of low and high b value DWI for detecting myocardial edema in acute myocarditis1567Value of Cardiac MRI In Detecting Coronary Artery Disease In Newly Diagnosed Systolic Dysfunction1570Usefulness of cardiac magnetic resonance in tuberous sclerosis complex1578Papillary muscles offer further insight into hypertrophied hearts: a cardiovascular magnetic resonance study1627Diagnostic and clinical implications of CMR timing (early versus late) in patients with troponin positive acute coronary syndromes and unobstructed coronary arteries: Table 1. [O] . Upasana Tayal, Alexandros Kallifatidis, P. Garg, 2016

机译：在使用新的扩张型心肌病的患者缓和EPOSTERS1385Longitudinal应变评估加速DENSE sequence1407Simultaneous T1和T2与CABIRIA心脏定量：在4维流动的加速算法初始临床experience1423Head对头比较CMR1502Left心室功能和尺寸由混合心脏正电子发射断层摄影术评价 - 磁性共振：由两个modalities1510Left庭派生左室射血分数和心室体积的个体间的比较，在1.5和3特斯拉评估心血管磁共振 - 免费的年龄和性别effects1514Comparison呼吸心脏MRI径向技术标准的多屏气电影SSFP CMR技术的LV卷和Function1536Self-导航自由呼吸各向同性3D整个心脏相位敏感反转恢复磁共振导航仪没有检测右Ventricu心肌infarction1547Assessment的评估拉尔菌株使用心肌变形恢复半自动技术：初步经验和正常Values1586Tissue跟踪心肌变形分析和预测左室重构急性心肌infarction1589Investigating策略优化31P MRS临床心脏在3T：初始Results1620Quantitative标准的先天缺失的诊断心包心脏磁Resonance1632Widespread组织损伤急性心肌梗死时：证据先进CMR relaxometry1322Computed CT冠状动脉成像与压力心脏磁共振对症的管理吻合血管患者：成本效益研究（战略研究）1339Comparison低与高剂量钆布醇在1.5特斯拉晚钆增强成像的临床可行性，在中间型地贫心脏并发症的预测study1347Multi参数心脏核磁共振的前瞻性德穆尔心血管磁共振的ticenter Study1461Prognostic价值衍生心肌纤维化指标在住院的急性期CMR的心脏移植recipients1523The作用：改变基于CMR-paradigms1542Preoperative比分预测缺血性心脏衰竭patients1555Excellent响应速度外科左心室重建心脏再同步化后心室反应治疗与磁共振imaging1626The ECG导引作为心脏磁共振成像致心律失常性基板的在ST段抬高心肌infarction1340Pathological在风险评估经历在3.0T CMR T1映射的室性早搏contractions1649Comparison和血管造影APPROACH分数区域消融患者的预测左束支传导疾病的患者与非缺血性心肌病相关因素：心血管磁共振study1342Myocardial重塑和纤维化nonischaemic扩张型心肌病：在从在由心血管磁性resonance1622Persistent心肌炎症评估肥厚型心肌病的纤维化和收缩功能障碍之间心血管磁性resonance1411The协会由于心肌内出血景点在再灌注STEMI为先导，以不利的LV重塑 - 从低的多参数mapping1566Semiquantitative分析和高的b值DWI的见解为在心脏MRI检测冠状动脉疾病急性myocarditis1567Value在结节性硬化症complex1578Papillary肌肉初诊收缩期Dysfunction1570Usefulness心脏磁共振检测心肌水肿提供进一步的深入了解肥大心脏：心血管磁共振study1627Diagnostic和CMR定时的临床意义（早期与晚）患者肌钙蛋白阳性的急性冠脉综合征和通畅的冠状动脉：表1。

Safety and Efficacy of Intracoronary Infusion of Allogeneic Human Cardiac Stem Cells in Patients With ST-Segment Elevation Myocardial Infarction and Left Ventricular Dysfunction: A Multicenter Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

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