BONAMI (BOne Marrow in Acute Myocardial Infarction)

Study Overview
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Brief Summary
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Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can be used to improve cardiac function in patients after acute myocardial infarction. In this randomised trial, we aim to assess whether intracoronary transfer of autologous bone-marrow cells could improve myocardial viability at 3 and 12 months' follow-up.

Detailed Description
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After successful percutaneous coronary intervention (PCI) for acute myocardial infarction, 100 patients are randomly assigned to either a control group (n=50) who receives an optimal medical treatment, or a bone-marrow-cell group (n=50) who receives an optimal medical treatment and intracoronary transfer of autologous bone-marrow cells 7•10 days after PCI.

Official Title
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Intracoronary Injection of Autologous Bone Marrow Mononuclear Cells for Severe Myocardial Infarction

Conditions
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Acute and Severe Myocardial Infarction

Intervention / Treatment
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* Procedure: Intracoronary injection of autologous bone marrow mononuclear cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women between 18-75 years. Acute myocardial infarction Absence of viability in the infarcted zone and LVEF <45%. Exclusion Criteria: History of prior myocardial infarction Significant stenosis in another coronary territory than the acutely treated vessel

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The treatment group<br>Intracoronary Injection of Autologous Bone Marrow Mononuclear C | Procedure: Intracoronary injection of autologous bone marrow mononuclear cells<br> <br> |
| No Intervention: the control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year) |  | after 3 months and 1 year of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricle ejection fraction (LVEF) evaluated by radionuclide ventriculography, (3 and 12 months) and by echography (1, 3, 6, and 12 months). Segmental EF and myocardial viability evaluated by MRI (3 months) |  | after 1,3,6 ,12 months of treatment | 
| Correlation with biological parameters (hematopoietic stem cell number, etc.) at the time of cell injection |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cell therapy, bone marrow mononuclear cells, myocardial infarction