Bone Marrow-Derived Stem Cell Transfer in Acute Myocardial Infarctions

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Completed

CT.gov ID

NCT00264316

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Procedure: bone marrow-derived stem cell transfer	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Official Title:

A Double-blind, Randomised, Controlled Study of Autologous Bone Marrow-Derived Stem Cell Transfer In Patients With ST-Segment Elevation Myocardial Infarction.

Study Start Date :

May 1, 2003

Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

increase in global LV ejection fraction fraction; evaluation by magnetic resonance (MRI) after 4 months []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiology, University Hospital Gasthuisberg	Leuven		Belgium	3000

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

Principal Investigator: Stefan Janssens, MD, PhD, Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium
Study Director: Frans Van de Werf, MD, PhD, Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium