Long Term Follow-up of Autologous Bone Marrow Mononuclear Cells Therapy in STEMI

Study Overview
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Brief Summary
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The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results. Our aim was to investigate 4 years' efficacy and LV functional improvement of autologous bone marrow mononuclear cells (BMMC) transplantation in patients with ST-elevation myocardial infarction.

Detailed Description
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The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results. Aim is to evaluate the long term efficiency of unselected bone marrow mononuclear cells in treatment of patients with ST-elevation myocardial infarction (STEMI), especially with regard to the left ventricular function. The cells are delivered by intracoronary infusion 7 days after the PCI. Outcomes including LVEF, myocardial viability and coronary artery status are assessed by echocardiography, SPECT and coronary angiography.

Official Title
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Long Term Functional Evaluation After Intracoronary Delivery of Autologous Bone Marrow Mononuclear Cells in Patients With ST-Elevation Myocardial Infarction

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: saline infusion
* Procedure: autologous bone marrow mononuclear cells infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ST segment elevation myocardial infarction, according to the WHO definition. <24 hour from the origin of symptoms. Single left anterior descending coronary artery disease. Successful revascularization of culprit lesion with PCI. Age between 45 and 65 years old. Written informed consent. Exclusion Criteria: Previous MI. Cardiomyopathy. Atrial fibrillation or fluctuation. Previous heart surgery. Severe valvular heart disease. Disease of the hematopoetic system. NYHA functional class IV at baseline. Severe renal, lung and liver disease or cancer. Significant coronary lesion in one or more major coronary vessels, requiring revascularization. Intra-cardiac thrombus.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Patients receive intracoronary injections of saline 7 days after PCI. | Procedure: saline infusion<br>* Patients receive intracoronary injections of saline 7 days after PCI.<br>* Other names: placebo control;|
| Experimental: 2<br>Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI. | Procedure: autologous bone marrow mononuclear cells infusion<br>* Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.<br>* Other names: autologous BMMC intracoronary injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Ejection Fraction(LVEF) |  | 1, 3, 6 months, 1, 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-stent restenosis |  | 1, 3, 6 months, 1, 4 years | 
| cardiac shock |  | 1, 3, 6 months, 1, 4 years | 
| myocardial viability of the infarcted area |  | 1, 3, 6 months, 1, 4 years | 
| end-diastolic Volume/end-systolic Volume(EDV/ESV) |  | 1, 3, 6 months, 1, 4 years | 
| wall motion score index(WMSI) |  | 1, 3, 6 months, 1, 4 years | 
| cumulative MACE(including cardiac death, non-fetal myocardial infarction and target lesion revascularization) |  | 1, 3, 6 months, 1, 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMMNC, STEMI, stem cell, intracoronary delivery