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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC133 recipients | Experimental | intra coronary injection of bone marrow derived AC133+ cells |
|
| MNC recipients | Experimental | intra coronary injection of bone marrow derived MNC |
|
| control | Active Comparator | injection of autologous serum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC133 | Biological | intra coronary injection of bone marrow derived AC133+ cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increase from baseline in ejection fraction | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hamid Gourabi, PhD | Royan Institute | Study Chair |
| Masoud Ghassemi, MD | Royan Institute | Principal Investigator |
| Nasser Aghdami, PhD,MD | Royan Institute | Study Director |
| Davood Kazemi saleh, MD | Royan Institute | Principal Investigator |
| Hossein Baharvand, PhD | Royan Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royan institute | Tehran | Iran |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000071916 | AC133 Antigen |
| ID | Term |
|---|---|
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| MNC | Biological | intra coronary injection of bone marrow derived MNC |
|
|
| CONTROL | Biological | autologous serum injection |
|
|
| 6 months |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |