The Application of the Umbilical Cord Mesenchymal Stem Cells in the Complex Treatment of Non-ischemic Heart Failure

This prospective, open-label, single-arm clinical trial investigated the safety and potential efficacy of intracoronary administration of allogeneic umbilical cord-derived mesenchymal stromal cells (MSCs) in patients with chronic non-ischemic heart failure. A total of 30 patients were enrolled. All participants received standard pharmacological therapy and underwent a single intracoronary infusion of 1×10⁷ MSCs delivered into the left coronary artery during routine cardiac catheterization. The primary objective was to assess the safety of the cell therapy over the first 5 days of hospitalization. Secondary outcomes included changes in left ventricular ejection fraction (LVEF), end-diastolic and end-systolic volumes and diameters, serum NT-proBNP levels, NYHA functional class, 6-minute walk test distance, and quality of life indicators (SF-12, KCCQ, MLHFQ) at 1, 3, and 6 months post-infusion. Although the study was originally registered with a control group and randomization, it was ultimately conducted as a single-arm design due to ethical and logistical constraints in recruitment. All patients received the same intervention, and no allocation or randomization was performed. While most patients had clinical indications for an implantable cardioverter-defibrillator (ICD) in accordance with international guidelines, not all had the device implanted due to personal refusal of the procedure. Therefore, ICD presence was not required for inclusion in the study. Although remuscularization of the myocardium was not a predefined endpoint, retrospective analysis revealed post-treatment thickening of the left ventricular posterior wall and interventricular septum in a subset of patients, as observed on cardiac computed tomography. This structural change was associated with improved systolic function and may guide future hypothesis-driven research.