A Randomized Clinical Trial of AdiPOse-derived Stem ceLLs in the Treatment of Patients With ST-elevation myOcardial Infarction - The APOLLO Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)
研究概览
简要总结
The purpose of this study is to establish safety and feasibility of utilizing Adipose-Derived Stem and Regenerative Cells (ADRC's) in patients who have suffered a ST-elevation acute myocardial infarction.
详细描述
Subjects who have coronary artery disease and have suffered a ST-elevation acute myocardial infarction will be evaluated for eligibility in this study. Eligible subjects will undergo standard treatment after admission to the hospital and will then undergo liposuction under local anesthesia, after which ADRC's will be isolated from the lipoaspirate. According to randomization subjects will receive either ADRC's or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myocardial infarction (AMI)
- •Clinical symptoms consistent with AMI for a minimum of 2 and a maximum of 12 hours from onset of symptoms to Percutaneous Coronary Intervention (PCI), and unresponsive to nitroglycerin
- •Successful revascularization of the culprit lesion in the major epicardial vessel
- •Area of hypo- or akinesia corresponding to the culprit lesion, as determined by left ventriculogram at the time of primary PCI
- •Left ventricular ejection fraction (LVEF) ≥30% and ≤50% by Left Ventricular Angiography at the time of successful revascularization.
- •Ability to undergo liposuction
排除标准
- •Prior MI, prior known cardiomyopathy, or prior hospital admission for congestive heart failure (CHF)
- •More than 24 hours after acute PCI
- •Significant valvular disease
- •More than twelve hours between the onset of first symptoms of AMI and revascularization
- •Hemodynamic instability within 24 hours prior to randomization
- •Neoplasia
- •Acute or chronic bacterial or viral infectious disease
- •Pacemaker, ICD or any other contra-indication for MRI
- •LVEF <30% or >50% by Left Ventricular Angiography
- •Moderate or severe COPD
研究组 & 干预措施
Placebo
Placebo is injected
干预措施: Injection of Placebo (Other)
Treatment
ADRC's are injected
干预措施: Injection of ADRC's (Drug)
结局指标
主要结局
Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)
时间窗: 6 months
次要结局
- Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography(6 months)