Bone Marrow Derived AC 133+ and Mono-Nuclear Cells (MNC) Implantation in Myocardial Infarction (MI) Patient

Study Overview
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Brief Summary
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Although a percutaneous coronary intervention (PCI) can be used to open up the blocked artery and restore blood flow to the heart muscle after myocardial infarction, there may be a significant amount of heart tissue that has been irreversibly damaged. Recent studies have shown that adult stem cells from bone marrow may be able to improve heart function and prevent from heart remodeling due to heart failure. This study will evaluate the safety and effectiveness of using adult bone marrow derived stem cells for improving heart function in MI patients with Left Anterior Descending (LAD) involvement.

Detailed Description
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Patient from both gender, who had acute MI within recent 3 Weeks in LAD territory and would underwent PCI are eligible for this study. The bone marrow derived AC 133+ and MNC would be intracoronary injected to the patients during PCI procedure. The control group would be received just serum during PCI. The patient would be followed every month and at the end of 6th and 18thmonth the case and control groups will be evaluated by stress echo and Tc99 scan. The totality of evidence from trials investigating autologous whole bone marrow infusion into patients following myocardial infarction supports the safety of this approach in terms of efficacy

Official Title
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Comparison the Therapeutic Outcomes of Bone Marrow Derived AC 133+ and Mono-Nuclear Cells (MNC) Implantation in Patient With Acute Myocardial Infarction Underwent PCI Procedure

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Biological: AC133
* Biological: MNC
* Biological: CONTROL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI> 30 First acute MI in LAD territory St elevation MI Ejection fraction: 20-45% at least two non - mobile or less mobile segment of left ventricular myocard. Successful PCI with stenting Exclusion Criteria: Multivessel ceremony artery disease Pulmonary edema SBP < 80 mmHg Thrombocytopenia (PLT < 50, 000) INR > 2 Hepatic failure or dysfunction Renal failure or dysfunction Positive HIV Ab/ HBC Ab/ HCV Ab/ HSV Ag Documental terminal illness Documental Malignancy Patient with sever coronary disease and unstability of vital sign History of leukopenia, Anemia, hepatic or renal dysfunction or malignancy

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: AC133 recipients<br>intra coronary injection of bone marrow derived AC133+ cells | Biological: AC133<br>* intra coronary injection of bone marrow derived AC133+ cells<br>* Other names: AC133 injection;|
| Experimental: MNC recipients<br>intra coronary injection of bone marrow derived MNC | Biological: MNC<br>* intra coronary injection of bone marrow derived MNC<br>* Other names: MNC injection;|
| Active Comparator: control<br>injection of autologous serum | Biological: CONTROL<br>* autologous serum injection<br>* Other names: placebo injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase from baseline in ejection fraction |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease LVESV/LVEDV/LVM index | left ventricular end systolic volume (LVESV) left ventricular end diastolic volume (LVEDV) Left Ventricular mass (LVM) | 6 months | 
| Decrease the number of Non Viable segments from baseline |  | 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 cell, AC133, mono nuclear cell