No stem-cell product for heart failure holds FDA approval. Investigational trials in the USA operate under IND protocols; major trials are enrolled at academic medical centres (Mayo Clinic, Cleveland Clinic, Stanford). European regulatory frameworks permit trial operation; some compassionate-use pathways exist for advanced-stage patients. Approval timelines are uncertain; several large pivotal trials are currently recruiting.
Heart failure reflects impaired cardiac contractility and/or relaxation, resulting from myocardial infarction, hypertension, cardiomyopathy, or valvular disease. Progressive cardiomyocyte death, fibrotic remodelling, and neuroendocrine dysregulation drive the syndrome. Placental mesenchymal stem cells and their exosomes limit adverse remodelling by secreting anti-fibrotic factors (anti-TGF-β signalling), promoting angiogenesis (VEGF, FGF), enhancing cardiomyocyte survival (paracrine anti-apoptotic signals), and modulating inflammatory infiltration (reduced macrophage pro-inflammatory activation). One hundred twenty-four registered clinical trials and twelve actively recruiting sites explore intracoronary or intravenous MSC delivery in post-infarction left-ventricular dysfunction, dilated cardiomyopathy, and advanced heart failure awaiting transplantation.
Am I a candidate? → · Heart Failure & Cardiac Repair: full overview → · Heart Failure & Cardiac Repair cost → · Cost →
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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