Intracoronary Infusion of Bone Marrow Mononuclear Cells in Patients With Previous Myocardial Infarction.
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.
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
研究概览
详细说明
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:
- Main objective: To determine the efficacy of intracoronary injection of adult stem cells from autologous bone marrow in patients with chronic anterior myocardial infarction in terms of improvement of ventricular function, determined by hemodynamic, echocardiographic and New York Heart Association (NYHA) functional class criteria, resulting in an improvement of heart failure symptoms and quality of life's patient.
Secondary objectives:
- To investigate the basic cellular mechanisms underlying the myocardial regeneration process through correlation between hemodynamic criteria for the ventricular function improvement and the biologicals corresponding to the composition and the functionality of the infused cells.
- To analyze clinical, hemodynamic and biologicals factors able to influence favorably to a greater degree of functional recovery after regenerative treatment in chronic myocardial infarction.
- To design, in view of the results obtained, suitable protocol for the application of cell therapy to treat patients with old anterior infarction, both in terms of the ideal characteristics of medullary graft as in terms of those patients more likely to be beneficiaries of it, in order to establish a definitive strategy of including cell therapy in the standard treatment of this disease in the near future provided that the results indicate it so.
The primary variable is the improvement in ventricular function monitoring under angiographic and echocardiographic parameters.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Cordoba、西班牙、14004
- University Hospital Reina Sofia
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Intervention
Dose of bone marrow mononuclear cells: 5-7 x 108 total cells
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Intracoronary infusion of autologous bone marrow-derived mononuclear cells
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Change from baseline in left ventricular ejection fraction (LVEF)
大体时间:3, 6 and 12 months after intervention
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3, 6 and 12 months after intervention
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次要结果测量
结果测量 |
大体时间 |
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Major Adverse Cardiac Events (MACE)
大体时间:12 months
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12 months
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Functional grade of the New York Heart Association (NYHA)
大体时间:3,6 and 12 months
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3,6 and 12 months
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合作者和调查者
调查人员
- 学习椅:Inmaculada Herrera, MD, PhD、University Hospital Reina Sofía, Córdoba.
- 学习椅:Jose Suarez de lezo, MD, PhD、University Hospital Reina Sofía, Córdoba.
- 首席研究员:Miguel Ángel Romero, MD、University Hospital Reina Sofía, Córdoba.
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Bone marrow mononuclear cells的临床试验
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University Health Network, TorontoWomen's College Hospital; Cleveland Clinic Canada尚未招聘