CD133+ Autologous Cells After Myocardial Infarction

Study Overview
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Brief Summary
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TITLE Intracoronary injection of CD133+ autologous hematopoietic cells after myocardial infarction. TRIAL DESIGN Pilot phase I/II parallel group study, with an untreated control group. SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction (AMI). TARGET POPULATION Patients (pts) with AMI treated with Primary Coronary Angioplasty (PTCA) with successful recanalization but unsuccessful reperfusion (myocardial blush (MB) grade 0 or 1 and less than 70% ST segment elevation resolution (STeR) (see Poli et al., Circulation, 2002). OBJECTIVES Primary: To evaluate the safety of intracoronary injection of CD133+ cells from autologous bone marrow (ABM) and mobilized peripheral blood (MPB) in the target population. To evaluate the efficacy, of the selective injection of CD133+ cells from ABM and MPB in the culprit vessel of the target population, on regional and global contractile function and on perfusion and metabolism of the infarcted area, depending on cell dose and comparing to controls. Secondary: To evaluate the disease-related morbility of the target population.

Official Title
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Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Procedure: cd133+cell intracoronary administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent; age: 18-65 years; large acute myocardial infarction (due to proximal occlusion of the left anterior descending or the right coronary artery) after successful primary PTCA carried out between the IV and the XXIV hour from the onset of AMI symptoms; signs of microvascular dysfunction in the infarcted area: absence of STeR and angiographic MB, graded according to the dye density score (see van't Hof et al., Circulation, 1998); life expectancy more than 6 months. Exclusion Criteria: Pregnancy; indication to aorto-coronaric by-pass; neoplasia (previous or in progress); primary diseases of the BM; diabetes; immunosuppressive therapy; laboratory alterations of protein S, protein C, ATIII or Fibrinogen; severe co-morbidity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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

| Intervention/Treatment |
| --- |
|Procedure: cd133+cell intracoronary administration|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3), |  |  | 
| Ejection fraction (%) evaluated by 2D echocardiography; |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perfusion/metabolism mismatch (P/Mm) evaluated by PET with Fluorine-18 fluorodeoxyglucose (FDG); |  |  | 
| Left Ventricular Wall Motion Score Index (LVWMSI) evaluated by 2D |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cell therapy, acute myocardial infarction