Estimation of clinical efficiency of umbilical cord blood total nucleated cells for recovery of impaired cardiac contractile function

The umbilical cord blood cells are a promising source for effective regenerative therapy of heart disease since they can be isolated in large numbers, easily cultivated and cryopreserved for long-term storage and subsequent use as needed, as well as characterized by high multipotent differentiation potential and low immunogenicity. Due to their additional anti-inflammatory and anti-fibrotic effects, umbilical cord blood progenitor and stem cells are considered as a unique source of cytokines and growth factors that can reduce the effects of myocardial ischemia and dystrophy

 

Study aim: to improve the efficiency of complex treatment of impaired cardiac contractile function by systemic and local stimulation of regenerative processes and implementation into the clinics the high-tech method of refractory heart failure treatment using cord blood total nucleated cells

 

Primary Endpoint:

  • Safety of cord blood total nucleated cells transplantation
  • Safety and efficacy of cell injections were assessed by reviewing clinical outcomes and adverse events at 6 time points: (1) 3 months, (2) 6 months, (3) 9 months, (4) 12 months, (5) 18 months and (6) 24 months follow-up
  • Major adverse events were adjudicated for observation: hospitalization, arrhythmia, exacerbation of congestive heart failure, acute coronary syndrome, myocardial infarction, stroke, multiple organ failure, death

Dosing regimen:single intravenous injection from 0,89·109to 0,95·109 cord blood total nucleated cells (CD34+cells – no less 1,0±0,01·103/ml) (n = 20)

 

No HLA matching or immunosuppression required

 

Results. Transplantation of umbilical cord blood total nucleated cells in the complex of conservative treatment of chronic heart failure of ischemic genesis has allowed to significantly improve the clinical outcomes of patients, increase the exercise tolerance, improve their quality of life, restore the reduced cardiac contractile function throughout the observation period. After the cell transplantation, no complications or adverse events were observed in the short-term and long-term follow-up points. Transplantation of umbilical cord blood total nucleated cells is a promising strategy that in combination with traditional methods of treatment will achieve the good results in patients with severe heart failure

 

Publications:

  • Usenko OYu, Yakushev AV, Kostylyev MV, Onischenko VF. Effect of transplantation of cord blood total nucleated cells on the manifestation and prognosis of refractory congestive heart failure. Cell and Organ Transplantology. 2016; 4(1):10-13. doi: 10.22494/COT.V4I1.6
  • Gabrielyan AV, Yakushev AB, Matyashchuk AS, Domanskiy TM, Kudlay IV, Romanova SV, Shymova AYu. Сhanges of intracardiac hemodynamics in patients with decreased myocardial contractility at transplantation of cord blood stem cells. Cell and Organ Transplantology. 2015; 3(1):24-27. doi: 10.22494/COT.V3I1.26
  • Usenko OYu, Yakushev AV, Lisun OV, Kostylev MV, Onishchenko VF. Heart rhythm safety of the mononuclear cord blood stem cells transplantation in patients with refractory ischemic heart failure. Cardiac Surgery and Interventional Cardiology. 2016, 3 (14): 15-20.[Article in Ukrainian].
  • Usenko OU, Salyutin RV, Yakushev AV, Sokolov MF, Onishchenko VF, Lobintseva GS. Changes in quality of life after cord blood stem cells transplantation in patients with decreased myocardial contractility. Ukr. med. chasopis. 2016. 1 (111):108-111.[Article in Ukrainian].
  • Usenko OYu, Stasenko АА, Yakushev AV, Domansky ТМ, Onishchenko VF. Evaluation of the effects of transplantation of mononuclear cord blood stem cells on the course and prognosis of refractory heart failure. Laboratory diagnostics Eastern Europe. 2016. 1(17):133-140.[Article in Russian].
  • Usenko ОYu, Salyutin RV, Yakushev АV, Sokolov МF, Lobintseva GS, Коstylyev МV, Onishchenko VF. Estimation of safety of transplantation of mononuclear stem cells of umbilical blood in patients, suffering cardiac insufficiency. Klin. Khir. 2016. 5:45-48.[Article in Ukrainian].
  • Usenko ОYu, Yakushev AV, Stasenko АА, Kostylev MV, Salyutin RV, Onishchenko VF. Changes in immune status of patients with refractory heart failure after transplantation of umbilical cord blood mononuclear stem cells and analysis of the activation of persistent TORCH-infection. Journal of the National Academy of Medical Sciences of Ukraine. 2015. 21(3-4):314-320.[Article in Ukrainian].
  • Gabrielan A., Vlasenko O., Yakushev A., Domanskiy T., Onischenko V. The course of clinical manifestations of coronary heart disease in patients after transplantation of umbilical cord blood stem cells [The Natural History of Coronary Heart Disease in Patients After Cord Blood Stem Cell Transplantation]. Visnyk sertsevo-sudynnoi khirurhii. 2015. 23:28-31.[Article in Ukrainian].
  • Usenko A, Smorzhevsky V, Habrielian A, Yakushev A, Domanskiy T, Kudlai I, Romanova S. Dynamics of heart failure manifestations in the short-term follow-up in patients with reduced myocardial contractility after transplantation of cord blood stem cells. Zbirnyk naukovykh prats spivrobitnykiv NMAPO imeni P.L. Shupyka. 2015. 24(2):100-107.[Article in Ukrainian].
  • Usenko OYu, Yakushev AV, Lisun OV, Domansky ТМ, Onishchenko VF. Electrophysiological features of cardiac rhythm changes in patients with decreased myocardial contractility after cord blood stem cell transplantation during short-term follow-up. Cardiac Surgery and Interventional Cardiology. 2014. 2(7):19-23.[Article in Ukrainian].
  • Poliachenko YuV, Gabrielyan AV, Domansky ТМ, Smorzhevsky VY, Onishchenko VF, Mazur AP, Romanova SV, Kudlay IV, Yakushev AV, Klymenko PP, Lobintseva GS, Shablii VA, Sokolov MF, Salyutin RV, Martynenko SI. The first experience of transplantation of stem cells on the terminal stage of chronic heart failure. Klin. Khir. 2014. 1,2(854):70-72.[Article in Ukrainian].
  • Yakushev A. The analysis of quality of life in the treatment of patients with reduced myocardial contractility. Zbirnyk naukovykh prats spivrobitnykiv NMAPO imeni P.L. Shupyka. 2014. 23(1):98-105.[Article in Ukrainian].
  • Smorzhevskyi V, Yakushev A, Domanskyi T. Influence of stem cell transplantation on the manifestations of heart failure and intracardiac hemodynamics. Zbirnyk naukovykh prats spivrobitnykiv NMAPO imeni P.L. Shupyka. 2014. 23(1):93-98.[Article in Ukrainian].
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