Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction

Study Overview
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Brief Summary
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One of the important reasons for human dying is Ischemic heart disease (IHD). The most reason is coronary artery disease. Beside morbidity, IHD induce myocardial infarction and necrosis which due to congestive heart failure. One therapeutic method is cellular cardiomyoplasty, which is to produce and substitute the cardiac cells with stem cell transplantation. Cell therapy is a potential therapeutic method to prevent ventricular remodeling after acute myocardial infarction. Human and animal studies have shown that stem cell trans plantation to myocardial infarcted zone can improve heart contractile function. The aim of this study is to comparison the effects of BM-derived AC133 and MNC implantation in patients with myocardial infarction.

Official Title
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Autologous Bone Marrow Derived Ac 133+ and Mono Nuclear Cells In-patient With Acute Myocardial Infarction During Coronary Artery Bypass Grafting (CABG): A Randomized Phase III Clinical Trial

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Biological: MNC
* Biological: AC 133
* Biological: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CABG candidate At least 4 akinetic segments First anterior heart attack within in 10 days to 3 month. St elevation MI defined by: Post Acute MI LVEF less than 45% as assessed by echocardiography. The target lesion had to be located in the left anterior descending (LAD) section. Exclusion Criteria: History of prior anterior myocardial infarction: History of prior CABG Poor echocardiography window. Active infection or history of recurrent infection or positive test for syphilis (RPR), hepatitis B and C (HBSAg/ Anti HBc Anti - Hcv) HIV and HTLV-l Documental terminal illness or malignancy. Previous bone marrow transplant Autoimmune disease (e. g Lupus, Multiple sclerosis) Any contraindication for bone - marrow aspiration. Positive pregnancy test (in women with child bearing potential)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MNC implantation<br>Implantation of BM derived MNC | Biological: MNC<br>* Implantation of BM derived MNC<br>* Other names: MNC injection;|
| Experimental: AC 133 implantation<br>Implantation of BM derived AC 133 | Biological: AC 133<br>* Implantation of BM derived AC133<br>* Other names: AC133 injection;|
| Placebo Comparator: Control<br>Injection of cell carrier | Biological: Control<br>* Injection of cell carrier<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction at rest, measured by gated SPECT |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional contractility in the AOI / Change in LV dimensions (left ventricular end systolic diameter [LVESD], left ventricular end diastolic diameter [LVEDD]) as assessed by echocardiography |  | 6 months | 
| changes in LVM index, LVEDV, LVESV |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, Bone marrow stem cells, AC133