Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-08-31

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.

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Detailed Description

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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stem cells

Group Type EXPERIMENTAL

Stem cell

Intervention Type DRUG

IV infusion of stem cells

Placebo

Group Type PLACEBO_COMPARATOR

Plasmalyte A

Intervention Type DRUG

IV infusion

Interventions

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Stem cell

IV infusion of stem cells

Intervention Type DRUG

Plasmalyte A

IV infusion

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No