Estimation of efficiency of cardiac-derived stem cells, bone marrow-derived, placenta-derived or adipose-derived multipotent mesenchymal stromal cells and their combinations in the treatment of patients with ischemic cardiomyopathy

In numerous clinical trials, it has been shown that application of various types of stem/progenitor cells increases myocardial perfusion and improves cardiac contractile function in patients with myocardial infarction, coronary artery disease, ischemic cardiomyopathy, and severe heart failure. Further investigation of multipotent mesenchymal stromal cells (MMSCs) of different origin, as well as tissue-specific cardiac stem cells, will enable to develop new biotechnological approaches in order to increase the efficacy of treatment of cardiovascular diseases and validate clinical efficacy of combined cell therapy

Study aim: to define the clinical effects of intramyocardial transplantation of cardiac-derived stem cells (CSCs), bone marrow-derived (BM-MMSCs), placenta-derived (P-MMSCs), adipose-derived multipotent mesenchymal stromal cells (A-MMSCs) or their combination on functional, structural, and electrophysiologic parameters of heart in patients with end-stage ischemic cardiomyopathy

Primary Endpoint:

  • Safety of intramyocardial multiple microinjections of stem cells
  • Safety of cell injections will be assessed by reviewing adverse events at 3 time points: (1) at 3 months post-treatment follow-up, (2) at 6 months post-treatment follow-up and (3) at 12 months post-treatment follow-up
  • Major adverse events were adjudicated: hospitalization, arrhythmia, exacerbation of congestive heart failure, acute coronary syndrome, myocardial infarction, stroke, multiple organ failure, death

Dosing regimen: coronary artery bypass grafting (CABG) with single or three intramyocardial multiple microinjections up to 15х107allogeneic MMSCs or 35·106autologous CSCs alone or in combination with autologous BM-MMSCs (n=100 in all groups); control group – CABG only (n=10)

No HLA matching or immunosuppression required

Estimation of efficiency of cardiac-derived stem cells, bone marrow-derived, placenta-derived or adipose-derived multipotent mesenchymal stromal cells and their combinations in the treatment of patients with ischemic cardiomyopathy

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