Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI

Study Overview
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Brief Summary
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This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells in patients with myocardial infarction.

Official Title
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A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase - i/ii Study Assessing the Safety and Efficacy of Intravenous ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With st Elevated Acute Myocardial Infarction (Stemi)

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Stem cell
* Drug: Plasmalyte A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with STEMI aged between 20 and 70 years, either males or females with non-child bearing potential, after 2 days of successful PCI. Patient has global left ventricular systolic dysfunction with an ejection fraction of <50% and >30%. ECG with sign of acute anterior MI with ST-elevation ≥ 2 mm in at least 2 of the following leads I, AVL, V1-V6, or ECG with sign of acute inferoposterior MI with ST-elevation ≥1 mm on all of the following leads- II, III, V5-V6 or STelevation ≥ 2 mm in at least 2 of the leads. The target lesion located in the proximal section of the left anterior descending, left circumflex or right coronary artery. Patient with acute myocardial infarction within 10 days prior to IP administration. Normal liver and renal function. Able to understand study information provided to him. Able to give voluntary written consent. Exclusion Criteria: History of acute/chronic inflammatory condition or severe aortic stenosis or insufficiency; severe mitral stenosis or severe mitral insufficiency. Severe co-morbidity associated with a reduction in life expectancy of less than 1 year. Advanced renal dysfunction and creatinine ≥ 2mg%. Advanced hepatic dysfunction. Have clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stem cells<br> | Drug: Stem cell<br>* IV infusion of stem cells<br>|
| Placebo Comparator: Placebo<br> | Drug: Plasmalyte A<br>* IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AE and ECG parameters |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional myocardial perfusion and infarct size |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mesenchymal stem cells, myocardial infarction