CONTROLLED CLINICAL TRIAL
JOURNAL ARTICLE
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Percutaneous, transendocardial injection of bone marrow-derived mononuclear cells in heart failure patients following acute ST-elevation myocardial infarction: ALSTER-Stem Cell trial.

EuroIntervention 2012 October
AIMS: Patients with symptomatic heart failure following acute ST-elevation myocardial infarction (STEMI) received transendocardial application of bone marrow-derived mononuclear cells (BMC) to improve left ventricular (LV) function and clinical outcome.

METHODS AND RESULTS: Patients (n=12) with LV ejection fraction (EF) <45% and NYHA Class ≥II received NOGA-guided transendocardial injection of BMC into the infarction border zone 17.5±0.8 days following successful interventional revascularisation after STEMI. A matched control group (n=11) was generated from the source data of the previously published LIPSIAbciximab-STEMI trial. Primary and secondary endpoints were derived from comparisons of baseline vs. six-month follow-up cardiac magnetic resonance imaging (CMR) measurements and clinical assessments. Following cell therapy we observed a significant increase of EF (+7.9±1.5%, p=0.001) while the control group showed no change. This effect was driven by a reduction of LV end-systolic volume (ESV) by -27.5±6.5 ml (p=0.001); LV end-diastolic volume (EDV) and scar volu-me remained unchanged. A significant decrease of NYHA Class was found only in the cell therapy group (-0.75 vs. -0.18, p=0.04). Findings were also translated into enhancement of clinical assessments (rehospitalisation for decompensated heart failure, six-minute walk test, NT-proBNP levels).

CONCLUSION: The data suggest transendocardial injection of BMC can be used safely in patients with sympto-matic heart failure following acute STEMI. These prospective, preliminary data of a well-characterised, small cohort suggest efficiency compared to routine treatment.

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