Functional improvement (ejection-fraction increase ≥5%, symptomatic relief, reduced dyspnoea or exercise intolerance) is reported in 45–60% of treated cohorts over 12 months. Heart-failure symptom class improvement (NYHA functional class reduction by ≥1 level) occurs in 40–50%. Complete ejection-fraction normalisation is uncommon; most benefit manifests as slowing decline, stabilisation, or modest improvement enabling reduced pharmacotherapy dependence or increased daily exertion capacity.
Clinical trial data encompasses phase I–II safety documentation and phase II efficacy assessment across >3,000 treated patients globally. Representative studies report left-ventricular ejection fraction (LVEF) improvements of 5–10 percentage points (e.g., 25% → 35%) in 40–55% of treated cohorts over 6–12 months. Cardiac magnetic resonance imaging shows reduction in scar size and infarct zone wall thickness in responders. Exercise tolerance (6-minute walk distance, VO₂ max) improves modestly in 45–50%. Hospitalisation rates for acute decompensation decline by 25–40% in some cohorts over 12-month follow-up. Mortality benefit remains unproven in phase II; pivotal trials are ongoing.
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Medically reviewed by StemCellAtlas’s editorial team with the Stem Plus medical team (physicians & scientists · GMP-certified Sofia laboratory · 25+ yrs international experience) of partner clinic Stem Plus (Sofia), against ISSCR, FDA & EMA guidance. Educational information, not medical advice; figures indicative.
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