Cell Therapy in Diabetic Patients With ST-Segment Elevation Myocardial Infarction(STEMI)

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy and mechanism of bone marrow mononuclear cells (BMMNC) transplantation for diabetic and non-diabetic patients with ST-segment elevation myocardial infarction (STEMI)who have undergone percutaneous coronary intervention (PCI).

Detailed Description
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Stem cells are capable of the important properties of self-renewal and differentiation plasticity. Human autologous bone marrow mononuclear cells (BMMNC) contain CD34+ haematopoietic and CD34- mesenchymal stem cells. Both of these cell types may contribute to heart muscle repair in acute myocardial infarction (AMI). In recent years, a variety of clinical trials have explored the hypothesis that BMMNC transplantation may enhance the recovery of left ventricular function after AMI. The use of BMMNC is clinically justified and ethically unquestionable because no severe side effects have been reported and immunosuppressive therapy is unnecessary. More over, our previous work showed that patients without diabetes may benefit more from BMMNC transplantation. Thus, the aim of the present study was to investigate the efficacy and mechanism of bone marrow mononuclear cells (BMMNC) transplantation for diabetic and non-diabetic patients with ST-segment elevation myocardial infarction (STEMI)who have undergone PCI.

Official Title
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Effects and Mechanism of Autologous Bone Marrow Mononuclear Cells (BMMNC)Transplantation in Diabetic Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Who Have Undergone Percutaneous Coronary Intervention (PCI)

Conditions
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Left Ventricular Function Systolic Dysfunction, Left Ventricular Function Diastolic Dysfunction, Death, Myocardial Reperfusion Injury

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 25 and 60 years old STEMI according to the WHO definition PCI <12 hours from the onset of symptoms LAD disease with an open infarct related artery Exclusion Criteria: previous myocardial infarction (MI) cardiomyopathy atrial fibrillation or flutter previous heart surgery severe valvular heart disease disease of the hematopoietic system NYHA functional class IV heart failure at baseline severe renal, lung and liver disease cancer intra-cardiac thrombus bone marrow disease

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetes<br>Patients with diabetes. | |
| non-diabetes<br>Patients without diabetes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient death during the follow up period | Number of patient death during the follow up period as a measure of safety | 4years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction | Left ventricular ejection fraction as evaluated by echocardiography and SPECT | 4 years | 
| Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT) |  | 4 years | 
| Infarct size as evaluated by Single-photon emission computed tomography (SPECT) |  | 4 years | 
| Number of target vessel revascularization | Number of target vessel revascularization during the follow up period | 4 years | 
| Angina class according to the canadian cardiovascular society (CCS) classification |  | 4 years | 
| Scores on the Seattle angina questionnaire |  | 4 years | 
| six-min walk distance (6MWD) | Quality of life as evaluated by 6-min walk distance | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Marrow Mononuclear cells;, Diabetes;, ST-segment Elevation Myocardial Infarction;, Percutaneous Coronary Intervention;, Left Ventricular Function