Skip to content

Bone Marrow-Derived Stem Cell Transfer in Acute Myocardial Infarctions

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00264316
Enrollment
68
Registered
2005-12-12
Start date
2003-05-31
Completion date
2005-12-31
Last updated
2013-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

bone marrow cell transfer, acute myocardial infarction, left ventricular function

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).

Interventions

PROCEDUREbone marrow-derived stem cell transfer

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 12, 2026