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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
-
Cordoba、スペイン、14004
- University Hospital Reina Sofia
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change from baseline in left ventricular ejection fraction (LVEF)
時間枠：3, 6 and 12 months after intervention
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3, 6 and 12 months after intervention
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Major Adverse Cardiac Events (MACE)
時間枠：12 months
|
12 months
|
|
Functional grade of the New York Heart Association (NYHA)
時間枠：3,6 and 12 months
|
3,6 and 12 months
|
協力者と研究者
捜査官
- スタディチェア：Inmaculada Herrera, MD, PhD、University Hospital Reina Sofía, Córdoba.
- スタディチェア：Jose Suarez de lezo, MD, PhD、University Hospital Reina Sofía, Córdoba.
- 主任研究者：Miguel Ángel Romero, MD、University Hospital Reina Sofía, Córdoba.
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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