The acute and long‐term effects of intracoronary Stem cell Transplantation in 191 patients with chronic heARt failure: the STAR‐heart study

Abstract

AimsDespite accumulated evidence that intracoronary bone marrow cell (BMC) therapy may be beneficial in acute myocardial infarction, there are only limited data available on the effectiveness of BMC's in chronic heart failure. The aim of this study was to quantitatively investigate ventricular haemodynamics, geometry, and contractility as well as the long-term clinical outcome of BMC treated patients with reduced left ventricular ejection fraction (LVEF) due to chronic ischaemic cardiomyopathy. Methods and resultsPatients with chronic heart failure (n ¼ 391 LVEF ≤35%) due to ischaemic cardiomyopathy were enrolled in the present study. Of these, 191 patients (mean NYHA class 3.22) underwent intracoronary BMC therapy. The control group (mean NYHA class 3.06) consisted of 200 patients with comparable LVEF. Assessments of haemodynamics at rest and exercise, quantitative ventriculography, spiroergometry, 24 h Holter ECG, late potentials, and heart rate variability were analysed. Over 3 months to 5 years after intracoronary BMC therapy there was a significant improvement in haemodynamics (e.g. LVEF, cardiac index), exercise capacity, oxygen uptake, and LV contractility. Importantly, there was a significant decrease in long-term mortality in the BMC treated patients compared with the control group. ConclusionIntracoronary BMC therapy improves ventricular performance, quality of life and survival in patients with heart failure. These effects were present when BMC were administered in addition to standard therapeutic regimes. No side effects were observed.--

Stem Cell Therapy for Heart Disease

“…83 STAR-Heart, the largest HF study, demonstrated improved ventricular function with significantly decreased mortality at 5 years. 79 Some trials did not show significant results, 76,85 while others demonstrated benefits, but no effect on EF. 66,67,74,77,80,84,86 A highly anticipated trial, FOCUS-CCTRN, assessed BMC via transendocardial injection in chronic HF.…”

“…43,53,54,62 Heart Failure Additionally, there have been multiple HF trials (Table 2). Many demonstrated benefits in ventricular function noted by increased EF, [68][69][70][71][72][73]75,79,82,83 improved functional class, 75,78,80,82,83,86 reduced infarct size, 70,72,80,[82][83][84] decreased mortality, 79 and acceptable safety outcomes. [66][67][68][69]75,78,80,[82][83][84]86 SCIPIO was the first trial using autologous CSC in HF and showed improvement in EF, infarct size, viable tissue, and HF scores.…”

Estado actual de la terapia con células madre en el tratamiento de las cardiopatías: An update

“…Por ejemplo, el estudio STAR-heart publicó su experiencia con el trasplante intracoronario de BMMC en pacientes con cardiopatía isquémica crónica con FEVI < 35% con seguimiento prolongado 63 . La terapia celular mejoró la función ventricular, la calidad de vida y la sobrevida, sugiriendo que la terapia puede ser eficaz aun a distancia de un evento coronario agudo 63 .…”

“…Por ejemplo, el estudio STAR-heart publicó su experiencia con el trasplante intracoronario de BMMC en pacientes con cardiopatía isquémica crónica con FEVI < 35% con seguimiento prolongado 63 . La terapia celular mejoró la función ventricular, la calidad de vida y la sobrevida, sugiriendo que la terapia puede ser eficaz aun a distancia de un evento coronario agudo 63 . Un reciente metaanálisis considerando otros 10 estudios aleatorios en pacientes con cardiopatía isquémica (n = 519), reportó que el tratamiento con BMMC se asoció a una mejoría significativa de la FEVI (+4,48%; p = 0,0001), menor volumen de fin de sístole (-20,64 ml, p = 0,001), y menor volumen de fin de diástole (-16,71 ml; p = 0,03) 64 .…”

Bone Marrow Derived Pluripotent Stem Cells in Ischemic Heart Disease: Bridging the Gap Between Basic Research and Clinical Applications

“…The benefit of BMCs therapy is less robust among patients with chronic ischemic heart disease (IHD) (Assmus et al, 2006;Strauer et al, 2010). Similarly, smaller studies have demonstrated the antianginal effects of BMCs in patients with non-revascularizable severe coronary artery disease (Losordo et al, 2007;Tse et al, 2007).…”