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
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
Контакты и местонахождение
Места учебы
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Cordoba, Испания, 14004
- University Hospital Reina Sofia
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Change from baseline in left ventricular ejection fraction (LVEF)
Временное ограничение: 3, 6 and 12 months after intervention
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3, 6 and 12 months after intervention
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Major Adverse Cardiac Events (MACE)
Временное ограничение: 12 months
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12 months
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Functional grade of the New York Heart Association (NYHA)
Временное ограничение: 3,6 and 12 months
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3,6 and 12 months
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Соавторы и исследователи
Следователи
- Учебный стул: Inmaculada Herrera, MD, PhD, University Hospital Reina Sofía, Córdoba.
- Учебный стул: Jose Suarez de lezo, MD, PhD, University Hospital Reina Sofía, Córdoba.
- Главный следователь: Miguel Ángel Romero, MD, University Hospital Reina Sofía, Córdoba.
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CMMo/CIC/2009
- 2009-016599-66 (Номер EudraCT)
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Клинические исследования Bone marrow mononuclear cells
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University Hospital, Basel, SwitzerlandЗавершенныйБиопсия костного мозгаШвейцария