Phase II Clinical Trial on the Effect of Intracoronary Infusion of Bone Marrow Mononuclear Cells on Functional Recovery in Patients With Myocardial Chronic Back and Severely Depressed Left Ventricular Function.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline in left ventricular ejection fraction (LVEF)
研究概览
简要总结
Phase II clinical trial which will include all patients diagnosed with chronic anterior myocardial infarction (more than 6 months from the acute phase and the complete revascularization in which it is assessed the evolution of left ventricular function in patients to the monitoring against their own basal condition.
Included patients will be studied in the following conditions:
- Basal condition: defined as the immediately preceding to the administration of cell therapy treatment.
- Monitoring Condition 1: three months after drug administration of cell therapy. Includes non-invasive methods of exploration of ventricular function.
- Monitoring Condition 2: six months after administration of treatment. Includes the same methods of exploration of ventricular function practised in the basal condition, including cardiac catheterism as well as non invasive methods.
- Monitoring Condition 3: twelve months after administration of the cell therapy drug. Includes non-invasive methods of exploration of ventricular function.
The trial hypothesis we propose consists of mononuclear cells of bone marrow providing progenitor cells with regenerative capacity and also secreting several angiogenic factors, and their implantation into ischemic tissues should contribute with both elements to the angiogenesis and tissue regeneration with myocardial functional recovery
详细描述
This is an uncontrolled study in which the efficacy of the cell therapy drug is measured by comparing the variables of ventricular function after treatment to the basal condition prior to its application
The total number of patients to be studied 20. The study population will correspond to male and female patients with chronic anterior myocardial infarction (more than 6 months after the acute episode) and ventricular dysfunction. It is expected 36 months of inclusion and one year follow up
Patients will receive in a concomitant way the drug treatment established by the good practice, so it would certainly be possible that some improvement occurs due to drug treatment.
It will be studied the patient population of both genders aged between 18 and 80 years diagnosed with Chronic anterior myocardial infarction (more than 6 months after the acute phase and the complete revascularization).
Objectives of the study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 80 years.
- •Patients diagnosed with Chronic anterior myocardial infarction (more than 6 months from the acute episode) with symptoms and / or signs of heart failure.
- •Left ventricular ejection fraction (LVEF)<45% and distensibility changes.
- •Complete revascularization performed at least 6 months before infusion cells.
排除标准
- •Patients in active waiting list for heart transplantation..
- •Treatable patients with resynchronization.
- •Patients over 80 years
- •Coexistence of other serious systemic diseases.
- •Active infection, HIV, Hepatitis B or Hepatitis C.
- •Patients with malignant or pre-malignant tumours.
- •Coexistence of any haematological disease.
- •Pregnant women, in breastfeeding period, or in childbearing potential age who are not using effective contraception.
- •Patients who are currently participating or have completed their participation in a clinical trial in a period of less than three months.
结局指标
主要结局
Change from baseline in left ventricular ejection fraction (LVEF)
时间窗: 3, 6 and 12 months after intervention
次要结局
- Major Adverse Cardiac Events (MACE)(12 months)
- Functional grade of the New York Heart Association (NYHA)(3,6 and 12 months)