A prospective, double blind, randomized, placebo-controlled clinical trial of intracoronaryinfusion of immunoselected, bone marrow-derived Stro3 mesenchymal precursor cells (MPC) inthe treatment of patients with ST-elevation myocardial infarction - The AMICI trial

Mesoblast, Inc.0 个研究点目标入组 225 人开始时间: 2013年2月11日最近更新: 2015年3月2日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Mesoblast, Inc.
入组人数: 225

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Subjects will be entered into this study only if they meet ALL of the following criteria:
•1.Willing and able to understand and sign the Informed Consent Form (ICF).
•2.Males or females = 18 years.
•3.Clinical symptoms consistent with AMI (pain, etc.) for a minimum of 2 and a maximum of 12 hours from onset of symptoms to percutaneous coronary intervention (PCI).
•4.De novo anterior Acute Myocardial Infarct (AMI) defined as:
•= 0.2 mV ST elevation in 2 or more V1 – V6 leads with presentation for a minimum of 2 hours and a maximum of 12 hours of onset of symptoms
•Presumed new left bundle branch block with a minimum of 0.1 mV concordant ST elevation with presentation for a minimum of 2 hours and a maximum of 12 hours of onset of symptoms
•Occlusion or flow limiting lesion in the left anterior descending coronary artery
•5.Successful revascularization of the culprit lesion in the LAD within 2-12 hours of the onset of AMI symptoms defined as (1) primary percutaneous coronary intervention (PCI) with stent implantation, resulting in TIMI 3 flow AND (2) residual stenosis of less than 20% by on-line QCA.
•6.If a female subject is of childbearing potential (not amenorrheic for the previous 24 months or not surgically sterile), the subject must be willing to use adequate contraception (hormonal pill, implant or intrauterine device, barrier methods only if used consistently) from the time of screening and for a period of at least 16 weeks after procedure.
•7.Female subjects of childbearing potential (not amenorrheic for the previous 24 months or not surgically sterile) must have a negative urine pregnancy test at screening, prior to study intervention.
•8.Must be willing and able to return for required follow-up visits.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 225
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 225

排除标准

•Subjects will not be enrolled into this study if they meet ANY of the following criteria:
•1.Prior MI, known cardiomyopathy, or hospital admission for heart failure (HF)
•2.Significant valvular disease (mitral of aortic valve regurgitation 3/4 classification as defined by ESC/ACC guidelines)
•3.More than 12 hours between the onset of first symptoms of AMI and revascularization
•4.Unsuccessful revascularization of culprit artery defined as less than TIMI 3 flow or residual diameter stenosis of 20% by on line QCA analysis
•5.Need for staged treatment of coronary artery disease, or other interventional or surgical procedures to treat heart disease (e.g., valve replacement, PCI or CABG) planned or scheduled within 6 months after the study procedure
•6.Cardiogenic shock or hemodynamic instability within 24 hours prior to randomization,
•defined as the presence of any of the following:
•Systolic blood pressure <80 mmHg lasting for more than 30 minutes
•Heart rate >120 bpm for more than 1 hour
•7.Prior coronary artery bypass graft to LAD
•8.History of persistent atrial fibrillation
•9.Prior PCI to LAD
•10.Malignancy within last 3 years from screening. The subject has had an active malignancy, within the past 3 years except for localized prostate cancer treated with hormone therapy or radiation therapy, cervical carcinoma in situ, breast cancer in situ, or non-melanoma skin cancer that has been definitively treated
•11.Acute or chronic bacterial or viral infectious disease
•12.Pacemaker, ICD or any other contra-indication for cMRI
•13.Known history of severe chronic obstructive pulmonary Disease (Forced Expiratory Volume (FEV1) <35% in 1 second).
•14.Known history of sensitization to human leukocyte antigens
•15.Known hypersensitivity to DMSO, murine proteins, bovine proteins, aspirin, clopidogrel, prasugrel, and/or metallic stents
•16.Prior or current participation in any stem cell study or any other investigational trial in the past 30 days.
•17.Pregnant or lactating women
•18.Intent to participate in any other investigational drug or cell therapy study during the 2-year follow-up period of this study
•19.Any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study

研究者

发起方

Mesoblast, Inc.

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