NCT02059512

Autologous Bone Marrow Mononuclear Cells in the Combined Treatment of Coronary Heart Disease

Influence of the Administration of Autologous Bone Marrow Mononuclear Cells for the Duration of Functioning Aorto-coronary Bypass Grafts in the Surgical Treatment of Coronary Heart Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: St. Petersburg State Pavlov Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study evaluate the effect of the method of administration of autologous bone marrow mononuclear cells for the duration of of functioning aorto-coronary bypass grafts in the surgical treatment of coronary heart disease, to assess the degree of effectiveness depending on the method of transplantation (intramyocardial, intracoronary, combined).

Detailed description

Additional estimation of safety: 1. Assessment of EuroScore II. 2. Hospital Stay. 3. The duration of stay in the intensive care unit. 4. Restoration of cardiac rhythm at the end of the main stage of operation (defibrillation/ self-recovery). 5. The time of extracorporeal circulation. 6. Time of anoxia. 7. Volume abjointed (drainage) postoperative day 1, day 3 8. Troponin I, CPK-MB, Myoglobin at 1, 3 postoperative days. 9. Hb/ HCT/K+ at the end of cardiopulmonary bypass (CPB) and Hb/ HCT/K+/ ABC at the end of the operation. 10. Assessment of the degree of manifestation of a systemic inflammatory reaction in the postoperative period - leukocytes (Leu), CRP 11. Postoperative complications (hydrothorax, hydropericardium, arrhythmias, resternotomy). 12. Echocardiography at 7-14 days after surgery. Estimation of efficiency: 1. Evaluation of systolic and diastolic myocardial function. Assessment of myocardial perfusion and metabolism (before and after treatment) - Speckle tracking echocardiography. 2. Patency of grafts within a specified time of treatment (angiography). 3. Dependence and duration of positive clinical effect on the amount of injected cell material. 4. Evaluation of the quality of life (Minnesota questionnaire, Seattle questionnaire, SF- 36 questionnaire). 5. All-cause Mortality Associated With the Progression of Basic 6. Disease.Dynamics of the functional class of angina. 7. Dynamics of the functional class of heart failure. 8. Dynamics of test data with a 6-minute walk. Predicting the results of treatment (the effect of a number of parameters): 1. Age. 2. Gender. 3. The body mass index. 4. Diabetes. 5. Smoking. 6. Family history of cardiovascular events. 7. Duration of ischemic heart disease. 8. Serum total cholesterol (+ fractions). 9. Leukocytosis and CRP level (initial level and rate of decrease in the postoperative period). 10. The level of creatinine. 11. The presence / absence of extracardiac arteriopathy. 12. The intramyocardial or intracoronary injection of BM-MNCs. 13. Assessment of the bone marrow: the number of nucleated cells, CD34 +, CD133 +.

Conditions

• Ischemic Heart Disease
• Bone Marrow Cells
• Coronary Artery Bypass Grafting (CABG)
• Heart Failure, Diastolic

Interventions

Type	Name	Description
PROCEDURE	Group 1	Coronary artery bypass grafting with intramyocardial administration of autologous bone marrow mononuclear cells 0.2 ml - 10 injection in the zone of blood supply LAD.
PROCEDURE	Group 0	Coronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.
PROCEDURE	Group 2	Coronary artery bypass grafting with intramyocardial and intracoronary administration of autologous bone marrow mononuclear cells intramyocardial administration 0.2 ml - 10 injection in the zone of blood supply LAD.

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-12-01
• Completion: 2018-01-01
• First posted: 2014-02-11
• Last updated: 2021-05-24
• Results posted: 2021-05-24

Locations

1 site across 1 country: Russia