Intracoronary Infusion of Concentrated Autologous Bone Marrow Mononuclear Cells in Acute Myocardial Infarction Patients Utilizing a Novel Point-of-Care Device for Rapid-Delivery of Stem Cells (AMIRST)
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Number of adverse events as a measure of safety
研究概览
简要总结
The primary objective of the study is to determine the feasibility and safety of intracoronary administration of autologous bone marrow derived mononuclear cell product in patients at risk for clinically significant cardiac dysfunction following AMI.
The secondary objective of the study is to assess the effect on cardiac function and infarct region perfusion. A concurrent placebo control patient group meeting eligibility but not receiving autologous bone marrow derived stem cells will be evaluated similar to the treated group to assess the rate of significant spontaneous improvement in cardiac function.
详细描述
Emerging evidence indicate that progenitor stem cells derived from bone marrow can be used to improve cardiac function in acute myocardial infarction patients. There is a great potential for stem cell therapy, using a variety of cell precursors to contribute to new blood vessel formation and muscle preservation in the myocardial infarct zone. The administration of cells via an infusion through the infarct related artery appears to be feasible and result in a clinical effect in some studies. Across the globe AMI is the leading cause of morbidity and mortality. This cannot be prevented by optimal standard therapies i.e. balloon or stent dilation of the infarct vessels.
The study is a double blind, placebo controlled, randomized, multicenter trial. Male or female patients between 18-75 years with first incidence of Acute Myocardial Infarction(AMI) and LVEF less than or equal to 40% are included in the study. Patients who have undergone successful percutaneous intervention (PCI) within ≤ 24 hours after onset of symptoms (PTCA/stent) or / and Thrombolysed patients having TIMI-3 flow are eligible to take part in the study.
A total of 30 subjects will be recruited and randomly assigned to receive concentrated BMMNC or placebo. All patients will undergo bone marrow aspiration within 3-10 days from the index event(infarction). Bone Marrow(BM) will be processed utilizing point of care technology. Following cell processing, the concentrated BMMNC or placebo control is infused directly into the infarct related artery using the stop flow method. Clinical follow up for all the subjects at 1,30, 60, 90, 180 and 360 days will be performed from the day of the procedure, with primary and secondary end points evaluated for both study arms.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female of age 18 - 75 years
- •Incidence of first myocardial infarction
- •Acute STEMI with LV hypokinesia involving anteroseptal, lateral or inferior walls
- •LVEF < 40% pre-intervention
- •Successful percutaneous intervention (PCI) within ≤ 24 hours after onset of symptoms (PTCA/stent) or / and Thrombolysed patients having TIMI-3 flow.
- •Written informed consent
排除标准
- •Multi-vessel coronary disease requiring surgical intervention (CABG) or left main coronary artery disease > 50% blockage
- •Previous history of CABG
- •Pulmonary edema
- •Cardiogenic shock
- •Myocarditis
- •Renal or hepatic dysfunction
- •Hematologic disease
- •General Exclusion Criteria:
- •Alcohol or drug dependency, active or uncontrolled acute myocarditis
- •HIV, HBV, or HCV infections
- •Evidence of malignant or hematological diseases
- •Metal implants of any kind
- •Claustrophobia
- •Renal insufficiency
- •History of bleeding disorder
- •Anemia (haemoglobin <8.5mg/dl)
- •Platelet count <100,000/ml
结局指标
主要结局
Number of adverse events as a measure of safety
时间窗: 12 Months
Feasibility and safety of Intracoronary infusion of autologous BMMNCs processed through intraoperative point of care technology, freedom from arrhythmia's.
次要结局
- Changes in the global Left Ventricular Ejection Fraction(LVEF), LV volumes-End Systolic Volume (ESV) and End Diastolic Volume (EDV), infarct size, myocardial mass, myocardial viability and regional wall motion abnormalities.(12 Months)
- Major adverse cardiac events (MACE)(12 Months)
- Quality of life(12 Months)