Safety and Efficacy on Cell-based Therapy in Patients With Recent Large Acute Myocardial Infarction

Study Overview
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Brief Summary
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The purpose of this study is to test bone marrow mononuclear cells for patients with recent heart attack who are at high risk of experiencing heart failure. This study drug is made of you own cells. Studies similar to this one have suggested that the use of cell-based transfer after heart attack can improve the recuperation of the heart. The purpose of this study is to assess whether cell transfer can improve the healing of the heart after a heart attack.

Official Title
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ReNEW: A Phase 2, Randomized, Placebo-Controlled, Double-Blinded Study of the Efficacy and Safety of Autologous Bone Marrow Mononuclear Cell Transfer for Myocardial Salvage in Acute Myocardial Infarction

Conditions
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Acute Myocardial Infarction, Heart Failure

Intervention / Treatment
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* Biological: Intracoronary delivery of unfractionated bone marrow mononuclear cells
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age and no more than 80 years of age. Acute ST-segment elevation MI Symptoms suggestive of acute MI ≥ 2mm ST-segment elevation in 2 or more precordial leads or ≥ 1mm in or more limb leads or new left bundle branch block Time from symptom onset to enrollment < 120 hours Left ventricular dysfunction by contrast ventriculography or echocardiography EF above 25 % and lower than 40% Focal wall motion akinesis or dyskinesis Clearly identifiable infarct artery Patent infarct artery (TIMI flow grade 2 or 3) of ≥ 2 mm in diameter following successful stent placement Exclusion Criteria: Planned treatment with bypass surgery or prior CABG Multi-vessel PCI Prior myocardial infarction by history or presence of pathologic Q-waves Active cardiogenic shock: mechanical ventilation, IABP, or vasopressors/inotropes Successful reperfusion < 3 hrs from symptom onset Prior MI or significant chronic heart failure Pacemaker/defibrillator Contraindication to MRI (metallic foreign body, claustrophobia, inability to lie flat) Significant hepatic dysfunction or renal insufficiency (estimated creatinine clearance<25 and/or serum Cr >2.5 mg/dl) Baseline hematocrit < 30 Pregnancy, or lactation/parturition within the past 30 days Active or planned treatment with chemotherapy Anticipated difficulty with 90-day follow-up Evidence of a serious, active infection in the opinion of the investigator including, but not limited to subjects who are HIV, hepatitis B or C positive Any known severe hematological disease, malignancy, systemic or life threatening disorder that would be incompatible with the trial Previous enrollment in this trial Participation in an investigational drug or device study within the past 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intracoronary delivery of unfractionated bone marrow mononuclear cells | Biological: Intracoronary delivery of unfractionated bone marrow mononuclear cells<br>* Maximal intracoronary cell dose: 50 x 10e7 cells diluted in 10 ml Maximal intracoronary volume: 10 ml (diluted in plasma and culture medium)<br>|
| Placebo Comparator: 2<br>Intracoronary delivery of placebo | Biological: Placebo<br>* Plasma and culture medium (10 ml)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the change of left ventricular ejection fraction between placebo-treated and cell-treated patients |  | baseline and 90 days | 
| Occurence of arrhythmia, heart failure and death |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in regional left ventricular function |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic resonance Imaging