Bone Marrow Transfer to Enhance ST-Elevation Infarct Regeneration

Status Completed

Clinical Trial Summary

After successful percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction, 60 patients were randomly assigned to either a control group (n=30) that received optimum postinfarction medical treatment, or a bone-marrow-cell group (n=30) that received optimum medical treatment and intracoronary transfer of autologous bone-marrow cells 4·8 days (SD 1·3) after PCI. Primary endpoint was global left-ventricular ejection fraction (LVEF) change from baseline to 6 months’ follow-up, as determined by cardiac MRI. Image analyses were done by two investigators blinded for treatment assignment. Analysis was per protocol.

Global LVEF at baseline (determined 3·5 days [SD 1·5] after PCI) was 51·3 (9·3%) in controls and 50·0 (10·0%) in the bone-marrow cell group (p=0·59). After 6 months, mean global LVEF had increased by 0·7 percentage points in the control group and 6·7 percentage points in the bone-marrow-cell group (P=0·0026).

Transfer of bone-marrow cells enhanced left-ventricular systolic function primarily in myocardial segments adjacent to the infarcted area. Cell transfer did not increase the risk of adverse clinical events, in-stent restenosis, or proarrhythmic effects.

Clinical Trial Description

Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can be used to improve cardiac function in patients after acute myocardial infarction. In this randomised trial, we aimed to assess whether intracoronary transfer of autologous bone-marrow cells could improve global left-ventricular ejection fraction (LVEF) at 6 months’ follow-up.

After successful percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction, 60 patients were randomly assigned to either a control group (n=30) that received optimum postinfarction medical treatment, or a bone-marrow-cell group (n=30) that received optimum medical treatment and intracoronary transfer of autologous bone-marrow cells 4·8 days (SD 1·3) after PCI. Primary endpoint was global left-ventricular ejection fraction (LVEF) change from baseline to 6 months’ follow-up, as determined by cardiac MRI. Image analyses were done by two investigators blinded for treatment assignment. Analysis was per protocol.

Global LVEF at baseline (determined 3·5 days [SD 1·5] after PCI) was 51·3 (9·3%) in controls and 50·0 (10·0%) in the bone-marrow cell group (p=0·59). After 6 months, mean global LVEF had increased by 0·7 percentage points in the control group and 6·7 percentage points in the bone-marrow-cell group (P=0·0026).

Transfer of bone-marrow cells enhanced left-ventricular systolic function primarily in myocardial segments adjacent to the infarcted area. Cell transfer did not increase the risk of adverse clinical events, in-stent restenosis, or proarrhythmic effects. Intracoronary transfer of autologous bone-marrow-cells promotes improvement of left-ventricular systolic function in patients after acute myocardial infarction. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00224536
Study type	Interventional
Source	Hannover Medical School
Contact
Status	Completed
Phase	Phase 1
Start date	January 2002
Completion date	October 2003

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