Bone Marrow-Derived Stem Cell Transfer in Acute Myocardial Infarctions

Phase 2

Completed

• Conditions: Myocardial Infarction

• Registration Number: NCT00264316
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

The benefit of reperfusion therapies for ST-elevation acute myocardial infarction (STEMI) is limited by postinfarction left ventricular (LV) dysfunction.The purpose of this study is to determine whether intracoronary transfer of bone marrow cells will augment left ventricular function recovery of the heart.

Detailed Description

Despite early coronary reperfusion, salvage of ischemic myocardium is incomplete and loss of viable myocardium initiates a process of adverse left ventricular (LV) remodeling1, compromising clinical outcome.

Experimental data have suggested that autologous bone marrow-derived or circulating progenitor cells may be beneficial for LV function recovery, but underlying mechanisms are unclear and prominent cardiomyocyte transdifferentiation has only been reported under selected experimental conditions. Early non-randomized clinical investigations indicate feasibility, safety and enhanced functional recovery after autologous human bone marrow-derived stem cell (BMSC) infusion into the infarct-related artery. More recently, a randomized open study demonstrated improvement of LV systolic function but not of LV remodeling following BMSC transfer.

In the absence of trials, in which the control group reproduces the exact conditions of the cell transfer group, including bone marrow aspiration and a placebo intracoronary injection, the true benefit of cell transfer cannot be fully appreciated.

We, therefore, designed a randomized, double-blind, and placebo-controlled exploratory study to investigate the effect of autologous BMSC transfer on LV functional and structural recovery after myocardial infarction. In view of the exploratory nature of the study and to detect potential mechanisms for the biological effect, we also assessed myocardial perfusion and oxidative metabolism using serial 1-\[11C\]acetate positron emission tomography (PET).

Study Timeline

• Study Start: 2003-05
• Status Verified: 2005-12
• Study Completion: 2005-12
• Study First Submitted: 2005-12-09
• Study First Submitted QC: 2005-12-09
• Study First Posted: 2005-12-12
• Last Update Submitted: 2013-01-16
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• patients with acute myocardial infarction with cumulative ST-segment elevation >=6mm, successful epicardial reperfusion after PCI and significant LV dysfunction

Exclusion Criteria

• patients presenting within 2 hours of symptom onset (no dilution of any treatment effect from aborted infarctions)
• patients with prior coronary artery bypass grafting, pulmonary edema, cardiogenic shock or significant co-morbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
increase in global LV ejection fraction fraction; evaluation by magnetic resonance (MRI) after 4 months

Secondary Outcome Measures

Name	Time	Method
change in infarct size and regional LV function; evaluation by magnetic resonance (MRI) after 4 months
change in myocardial perfusion and oxidative metabolism; investigated using serial 1-[11C]acetate positron emission tomography after 4 months

Trial Locations

Locations (1)

Department of Cardiology, University Hospital Gasthuisberg; 🇧🇪 Leuven, Belgium