Overview

This trial is active, not recruiting.

Condition ischemic heart disease
Treatments coronary artery bypass grafting with administration of autologous bone marrow stem cells, coronary artery bypass grafting with administration of 0.9 % nacl (sodium chloride) 0.2 ml
Phase phase 3
Sponsor St. Petersburg State Pavlov Medical University
Start date February 2013
End date December 2016
Trial size 100 participants
Trial identifier NCT02059512, NBK-2901-AMNKM

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Active Comparator)
intramyocardial administration of autologous bone marrow mononuclear cells during the operation coronary artery bypass grafting
coronary artery bypass grafting with administration of autologous bone marrow stem cells
(Placebo Comparator)
intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml
coronary artery bypass grafting with administration of 0.9 % nacl (sodium chloride) 0.2 ml
(Active Comparator)
intramyocardial and intracoronary administration of autologous bone marrow mononuclear cells during coronary artery bypass grafting
coronary artery bypass grafting with administration of autologous bone marrow stem cells

Primary Outcomes

Measure
All-cause mortality associated with the progression of basic disease
time frame: up to 60 months

Secondary Outcomes

Measure
Quality of life
time frame: one year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Men and women from 18 to 80 years - Patients with angina pectoris III-IV functional class - Patients signed informed consent Exclusion Criteria: - Intolerance of heparin and HES. - Hypothyroidism and hyperthyroidism. - Associated pathology with a projected lifespan limitation to 3 years. - infection diseases - Simultaneous participation in another study. - Pregnancy. - Severe mental disorder. - Refusal of a patient to participate in the study.

Additional Information

Official title 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
Principal investigator Alexander S Nemkov, MD, Ph.D
Description Additional estimation of safety: 1. Assessment of EuroScore II. 2. The duration of stay in the intensive care unit. 3. Restoration of cardiac rhythm at the end of the main stage of operation (defibrillation / self-recovery). 4. The time of extracorporeal circulation. 5. Time of anoxia. 6. The amount of blood loss by drainage in the 1st day. 7. The amount of discharge during the second day. 8. Troponin I at 1, 2, 3 postoperative days. 9. Postoperative complications (hydrothorax, hydropericardium, arrhythmias). 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 +.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by St. Petersburg State Pavlov Medical University.