Trial Outcomes & Findings for Autologous Bone Marrow Mononuclear Cells in the Combined Treatment of Coronary Heart Disease (NCT NCT02059512)

NCT ID: NCT02059512

Last Updated: 2021-05-24

Results Overview

EuroScoreII is intended to assess the risk of adverse outcome of coronary artery bypass grafting. Assessment factors: age, sex, serum creatinine, extracardiac artery disease, chronic lung disease, severe neurological disorders, previous cardiac surgery, previous myocardial infarction, left ventricular dysfunction, diabetes mellitus, pulmonary hypertension, IV class of angina severity, active endocarditis, unstable angina, surgery, critical condition of the patient before surgery, type of surgery. The higher the percentage, the higher the risk of surgery.

Recruitment status

COMPLETED

Study phase

Target enrollment

117 participants

Primary outcome timeframe

Before CABG surgery at baseline.

Results posted on

2021-05-24

Participant Flow

Potential participants in the study were all patients referred to the clinic for surgical treatment of coronary artery disease.

The study included patients admitted for routine coronary artery bypass grafting under cardiopulmonary bypass, and having, according to the angiographic studies, 3 or more of stenosed coronary arteries. Patients met the inclusion criteria and signed an informed voluntary consent.

Participant milestones

Participant milestones
Measure	Intramyocardial Administration 0.9 % NaCl (Sodium Chloride) - Group 0 Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Intramyocardial Administration Autologous Bone Marrow Stem Cells - Group 1 Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.	Intramyocardial and Intracoronary Administration Autologous Bone Marrow Stem Cells - Group 2 Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.
Overall Study STARTED	46	34	37
Overall Study COMPLETED	37	25	23
Overall Study NOT COMPLETED	9	9	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The analysis of the final statistics was made at the time the studies were completed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intramyocardial Administration 0.9 % NaCl (Sodium Chloride) - Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Intramyocardial Administration Autologous Bone Marrow Stem Cells - Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow mononuclear cells 0.2 ml - 10 injection in the zone of blood supply LAD.	Intramyocardial and Intracoronary Administration Autologous Bone Marrow Stem Cells - Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial ( 0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow mononuclear cells.	Total n=85 Participants Total of all reporting groups
Angiotensin receptor antagonists.	5 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
β-blockers.	35 Participants n=5 Participants	20 Participants n=7 Participants	23 Participants n=5 Participants	78 Participants n=4 Participants
Antagonists СА - calcium tubules antagonists.	5 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	18 Participants n=7 Participants	20 Participants n=5 Participants	67 Participants n=4 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	18 Participants n=4 Participants
Age, Continuous	61 years STANDARD_DEVIATION 8 • n=5 Participants	61.7 years STANDARD_DEVIATION 6.8 • n=7 Participants	59.5 years STANDARD_DEVIATION 5.4 • n=5 Participants	60.9 years STANDARD_DEVIATION 6.96 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants • The analysis of the final statistics was made at the time the studies were completed.	4 Participants n=7 Participants • The analysis of the final statistics was made at the time the studies were completed.	3 Participants n=5 Participants • The analysis of the final statistics was made at the time the studies were completed.	13 Participants n=4 Participants • The analysis of the final statistics was made at the time the studies were completed.
Sex: Female, Male Male	31 Participants n=5 Participants • The analysis of the final statistics was made at the time the studies were completed.	21 Participants n=7 Participants • The analysis of the final statistics was made at the time the studies were completed.	20 Participants n=5 Participants • The analysis of the final statistics was made at the time the studies were completed.	72 Participants n=4 Participants • The analysis of the final statistics was made at the time the studies were completed.
Region of Enrollment Russia	37 participants n=5 Participants	25 participants n=7 Participants	23 participants n=5 Participants	85 participants n=4 Participants
BMI	28.6 kg/m^2 STANDARD_DEVIATION 3.59 • n=5 Participants	28.05 kg/m^2 STANDARD_DEVIATION 4.46 • n=7 Participants	28.09 kg/m^2 STANDARD_DEVIATION 3.57 • n=5 Participants	28.3 kg/m^2 STANDARD_DEVIATION 3.4 • n=4 Participants
Diabetes	6 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Hypertonic desease (stage). 2 stage	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Hypertonic desease (stage). 3 stage	36 Participants n=5 Participants	25 Participants n=7 Participants	23 Participants n=5 Participants	84 Participants n=4 Participants
Arterial hypertension (degree) No	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Arterial hypertension (degree) 1 degree	6 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Arterial hypertension (degree) 2 degree	14 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	32 Participants n=4 Participants
Arterial hypertension (degree) 3 degree	15 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	30 Participants n=4 Participants
Peripheral arteriopathy.	11 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	21 Participants n=4 Participants
Acute myocardial infarction transferred in history (number). 1 acute myocardial infarctions	14 Participants n=5 Participants	17 Participants n=7 Participants	9 Participants n=5 Participants	40 Participants n=4 Participants
Acute myocardial infarction transferred in history (number). 2 acute myocardial infarctions	4 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	13 Participants n=4 Participants
Acute myocardial infarction transferred in history (number). 3 acute myocardial infarctions	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Smoking.	7 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Family history of cardiovascular disease.	19 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	40 Participants n=4 Participants
Debut of ischemic heart disease (months).	71.9 months STANDARD_DEVIATION 70.9 • n=5 Participants	62.9 months STANDARD_DEVIATION 79.2 • n=7 Participants	76.9 months STANDARD_DEVIATION 59.4 • n=5 Participants	69.3 months STANDARD_DEVIATION 60.3 • n=4 Participants
Debut of ischemic heart disease. Debut of ischemic heart disease up to 5 years	23 Participants n=5 Participants	16 Participants n=7 Participants	12 Participants n=5 Participants	51 Participants n=4 Participants
Debut of ischemic heart disease. Debut of ischemic heart disease 6-10 years	8 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	20 Participants n=4 Participants
Debut of ischemic heart disease. Debut of ischemic heart disease over 10 years	6 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants
Angina pectoris (functional class). 2 functional class	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Angina pectoris (functional class). 3 functional class	32 Participants n=5 Participants	23 Participants n=7 Participants	21 Participants n=5 Participants	76 Participants n=4 Participants
Angina pectoris (functional class). 4 functional class	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Antiplatelet agents.	18 Participants n=5 Participants	12 Participants n=7 Participants	9 Participants n=5 Participants	39 Participants n=4 Participants
Angina pectoris (functional class). painless ischemia	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Heart failure (functional class NYHA). 1 functional class	5 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Heart failure (functional class NYHA). 2 functional class	29 Participants n=5 Participants	24 Participants n=7 Participants	21 Participants n=5 Participants	74 Participants n=4 Participants
Heart failure (functional class NYHA). 3 functional class	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Total holesterol (mmol/l).	4.49 mmol/l STANDARD_DEVIATION 1.08 • n=5 Participants	4.5 mmol/l STANDARD_DEVIATION 1.24 • n=7 Participants	4.6 mmol/l STANDARD_DEVIATION 1.49 • n=5 Participants	4.5 mmol/l STANDARD_DEVIATION 1.1 • n=4 Participants
Very loud density lipoprotein (mmol/l).	0.96 mmol/l STANDARD_DEVIATION 0.35 • n=5 Participants	0.94 mmol/l STANDARD_DEVIATION 0.5 • n=7 Participants	0.77 mmol/l STANDARD_DEVIATION 0.3 • n=5 Participants	0.95 mmol/l STANDARD_DEVIATION 0.31 • n=4 Participants
High density lipoproteins (mmol/l).	2.7 mmol/l STANDARD_DEVIATION 0.89 • n=5 Participants	2.58 mmol/l STANDARD_DEVIATION 1.05 • n=7 Participants	2.7 mmol/l STANDARD_DEVIATION 1.26 • n=5 Participants	2.6 mmol/l STANDARD_DEVIATION 1.1 • n=4 Participants
Loud density lipoproteins (mmol/l).	0.98 mmol/l STANDARD_DEVIATION 0.31 • n=5 Participants	1.16 mmol/l STANDARD_DEVIATION 0.37 • n=7 Participants	1.13 mmol/l STANDARD_DEVIATION 0.29 • n=5 Participants	1.1 mmol/l STANDARD_DEVIATION 0.3 • n=4 Participants
Triglyceride (mmol/l).	2.04 mmol/l STANDARD_DEVIATION 0.68 • n=5 Participants	1.69 mmol/l STANDARD_DEVIATION 0.72 • n=7 Participants	1.63 mmol/l STANDARD_DEVIATION 0.62 • n=5 Participants	1.9 mmol/l STANDARD_DEVIATION 0.65 • n=4 Participants
Atherogenic coefficient.	4.07 ratio STANDARD_DEVIATION 1.32 • n=5 Participants	3.27 ratio STANDARD_DEVIATION 1.9 • n=7 Participants	4.5 ratio STANDARD_DEVIATION 5.2 • n=5 Participants	4.08 ratio STANDARD_DEVIATION 2.1 • n=4 Participants
Creatinine (mmol / l).	0.09 mmol/l STANDARD_DEVIATION 0.02 • n=5 Participants	0.09 mmol/l STANDARD_DEVIATION 0.02 • n=7 Participants	0.08 mmol/l STANDARD_DEVIATION 0.02 • n=5 Participants	0.09 mmol/l STANDARD_DEVIATION 0.02 • n=4 Participants
C-reactive protein (mg/l).	5.9 mg/l STANDARD_DEVIATION 11.07 • n=5 Participants	2.56 mg/l STANDARD_DEVIATION 1.96 • n=7 Participants	5.3 mg/l STANDARD_DEVIATION 5.38 • n=5 Participants	4.9 mg/l STANDARD_DEVIATION 6.8 • n=4 Participants
Glomerular filtration rate (ml/min/1.73 m^2) (assessment of renal function).	79.89 ml/min/1.73 m^2 STANDARD_DEVIATION 15.8 • n=5 Participants	77.6 ml/min/1.73 m^2 STANDARD_DEVIATION 16.03 • n=7 Participants	84.2 ml/min/1.73 m^2 STANDARD_DEVIATION 17.26 • n=5 Participants	77.9 ml/min/1.73 m^2 STANDARD_DEVIATION 16.8 • n=4 Participants
EuroScore II	1.3 percentage of risk STANDARD_DEVIATION 0.68 • n=5 Participants	1.07 percentage of risk STANDARD_DEVIATION 0.47 • n=7 Participants	1.02 percentage of risk STANDARD_DEVIATION 0.4 • n=5 Participants	1.15 percentage of risk STANDARD_DEVIATION 0.5 • n=4 Participants
SYNTAX Score	26.7 units on a scale STANDARD_DEVIATION 7.0 • n=5 Participants	26.8 units on a scale STANDARD_DEVIATION 6.0 • n=7 Participants	26.4 units on a scale STANDARD_DEVIATION 7.3 • n=5 Participants	26.7 units on a scale STANDARD_DEVIATION 6.4 • n=4 Participants
Nitrates.	21 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	42 Participants n=4 Participants
Diuretics.	5 Participants n=5 Participants	10 Participants n=7 Participants	3 Participants n=5 Participants	18 Participants n=4 Participants
Angiotensin converting enzyme inhibitors.	18 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants	43 Participants n=4 Participants
Anticoagulants.	6 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Statins.	27 Participants n=5 Participants	16 Participants n=7 Participants	15 Participants n=5 Participants	58 Participants n=4 Participants
Echocardiography - 1. Lvd ind. Lvs ind. LAind. Lvd ind.	2.7 mm/ m^2 STANDARD_DEVIATION 0.39 • n=5 Participants	2.98 mm/ m^2 STANDARD_DEVIATION 0.5 • n=7 Participants	2.8 mm/ m^2 STANDARD_DEVIATION 0.2 • n=5 Participants	2.8 mm/ m^2 STANDARD_DEVIATION 0.36 • n=4 Participants
Echocardiography - 1. Lvd ind. Lvs ind. LAind. Lvs ind.	1.8 mm/ m^2 STANDARD_DEVIATION 0.42 • n=5 Participants	2.1 mm/ m^2 STANDARD_DEVIATION 0.5 • n=7 Participants	1.9 mm/ m^2 STANDARD_DEVIATION 0.4 • n=5 Participants	1.9 mm/ m^2 STANDARD_DEVIATION 0.44 • n=4 Participants
Echocardiography - 1. Lvd ind. Lvs ind. LAind. LAind.	2.1 mm/ m^2 STANDARD_DEVIATION 0.3 • n=5 Participants	2.2 mm/ m^2 STANDARD_DEVIATION 0.3 • n=7 Participants	2.1 mm/ m^2 STANDARD_DEVIATION 0.2 • n=5 Participants	2.2 mm/ m^2 STANDARD_DEVIATION 0.27 • n=4 Participants
Echocardiography - 2. LVEDV MOD BP ind. LVESV MOD BP ind. LVEDV MOD BP ind.	62.4 ml/ m^2 STANDARD_DEVIATION 20.7 • n=5 Participants	73 ml/ m^2 STANDARD_DEVIATION 36.1 • n=7 Participants	73.2 ml/ m^2 STANDARD_DEVIATION 29.9 • n=5 Participants	62.7 ml/ m^2 STANDARD_DEVIATION 28.9 • n=4 Participants
Echocardiography - 2. LVEDV MOD BP ind. LVESV MOD BP ind. LVESV MOD BP ind.	23.6 ml/ m^2 STANDARD_DEVIATION 14.8 • n=5 Participants	32.4 ml/ m^2 STANDARD_DEVIATION 27.9 • n=7 Participants	31.9 ml/ m^2 STANDARD_DEVIATION 22.3 • n=5 Participants	27.9 ml/ m^2 STANDARD_DEVIATION 21.7 • n=4 Participants
Echocardiography - 3. LVEF (Simpson) - left ventricular ejection fraction.	62.1 percent STANDARD_DEVIATION 7.4 • n=5 Participants	56.6 percent STANDARD_DEVIATION 10.2 • n=7 Participants	59.3 percent STANDARD_DEVIATION 11.1 • n=5 Participants	59.8 percent STANDARD_DEVIATION 9.6 • n=4 Participants
Echocardiography - 4. Left ventricular diastolic function - 1. Peak E of transmitral flow	0.7 m/sec STANDARD_DEVIATION 0.2 • n=5 Participants	0.6 m/sec STANDARD_DEVIATION 0.1 • n=7 Participants	0.7 m/sec STANDARD_DEVIATION 0.2 • n=5 Participants	0.7 m/sec STANDARD_DEVIATION 0.2 • n=4 Participants
Echocardiography - 4. Left ventricular diastolic function - 1. Peak A of transmitral flow	0.8 m/sec STANDARD_DEVIATION 0.2 • n=5 Participants	0.8 m/sec STANDARD_DEVIATION 0.2 • n=7 Participants	0.7 m/sec STANDARD_DEVIATION 0.2 • n=5 Participants	0.7 m/sec STANDARD_DEVIATION 0.2 • n=4 Participants
Echocardiography - 5. Left ventricular diastolic function - 2 (E/A).	0.9 ratio STANDARD_DEVIATION 0.4 • n=5 Participants	0.9 ratio STANDARD_DEVIATION 0.5 • n=7 Participants	0.9 ratio STANDARD_DEVIATION 0.5 • n=5 Participants	0.9 ratio STANDARD_DEVIATION 0.47 • n=4 Participants
Echocardiography - 6. Left ventricular diastolic function - 3 (DT, IVRT). DT (Half-time of wave E)	253 ms. STANDARD_DEVIATION 52.7 • n=5 Participants	257.6 ms. STANDARD_DEVIATION 46.3 • n=7 Participants	252.3 ms. STANDARD_DEVIATION 55.1 • n=5 Participants	254.7 ms. STANDARD_DEVIATION 51.4 • n=4 Participants
Echocardiography - 6. Left ventricular diastolic function - 3 (DT, IVRT). IVRT (time of isovolumic relaxation of the left ventriclar)	103.4 ms. STANDARD_DEVIATION 11.1 • n=5 Participants	106 ms. STANDARD_DEVIATION 9.8 • n=7 Participants	105.3 ms. STANDARD_DEVIATION 13.9 • n=5 Participants	104.7 ms. STANDARD_DEVIATION 11.6 • n=4 Participants
Echocardiography - 7. LVmass/ BSA (g/m^2)	119.1 g/m^2 STANDARD_DEVIATION 29 • n=5 Participants	152.8 g/m^2 STANDARD_DEVIATION 48 • n=7 Participants	134.04 g/m^2 STANDARD_DEVIATION 32 • n=5 Participants	135.3 g/m^2 STANDARD_DEVIATION 36.3 • n=4 Participants
Echocardiography - 8. RWT - relative wall thickness of the left ventricle.	0.44 ratio STANDARD_DEVIATION 0.07 • n=5 Participants	0.4 ratio STANDARD_DEVIATION 0.07 • n=7 Participants	0.4 ratio STANDARD_DEVIATION 0.06 • n=5 Participants	0.43 ratio STANDARD_DEVIATION 0.07 • n=4 Participants
Echocardiography - 9. Mitral regurgitation. Not	16 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	30 Participants n=4 Participants
Echocardiography - 9. Mitral regurgitation. 1 degree Mitral regurgitation.	19 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants	45 Participants n=4 Participants
Echocardiography - 9. Mitral regurgitation. 2 degree Mitral regurgitation.	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Echocardiography - 9. Mitral regurgitation. 3 degree Mitral regurgitation.	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Echocardiography - 10. Tricuspid regurgitation. Not	25 participants n=5 Participants	22 participants n=7 Participants	19 participants n=5 Participants	66 participants n=4 Participants
Echocardiography - 10. Tricuspid regurgitation. 1 degreeTricuspid regurgitation	12 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	19 participants n=4 Participants
Echocardiography - 10. Tricuspid regurgitation. 2 degreeTricuspid regurgitation	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Echocardiography - 10. Tricuspid regurgitation. 3 degreeTricuspid regurgitation	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Echocardiography - 11. Aortic regurgitation. Not	25 participants n=5 Participants	23 participants n=7 Participants	22 participants n=5 Participants	70 participants n=4 Participants
Echocardiography - 11. Aortic regurgitation. 1 degree Aortic regurgitation.	11 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	14 participants n=4 Participants
Echocardiography - 11. Aortic regurgitation. 2 degree Aortic regurgitation.	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Echocardiography - 11. Aortic regurgitation. 3 degree Aortic regurgitation.	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Echocardiography - 12. Signs of myocardial remodeling. Left ventricular diastolic function/ · Yes	19 Participants n=5 Participants	17 Participants n=7 Participants	16 Participants n=5 Participants	52 Participants n=4 Participants
Echocardiography - 12. Signs of myocardial remodeling. Left ventricular diastolic function/ · Not	18 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	33 Participants n=4 Participants
Echocardiography - 12. Signs of myocardial remodeling. Left ventricular aneurysm. · Yes	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Echocardiography - 12. Signs of myocardial remodeling. Left ventricular aneurysm. · Not	35 Participants n=5 Participants	21 Participants n=7 Participants	20 Participants n=5 Participants	76 Participants n=4 Participants
Echocardiography - 12. Signs of myocardial remodeling. Change in local kinetics. · Yes	23 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	46 Participants n=4 Participants
Echocardiography - 12. Signs of myocardial remodeling. Change in local kinetics. · Not	14 Participants n=5 Participants	14 Participants n=7 Participants	11 Participants n=5 Participants	39 Participants n=4 Participants

PRIMARY outcome

Timeframe: Before CABG surgery at baseline.

Population: The data of all patients initially included in the study were analyzed.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Assessment of the Initial Risk of Surgery (EuroScore II).	1.02 percent Standard Deviation 0.4	1.3 percent Standard Deviation 0.68	1.07 percent Standard Deviation 0.47

PRIMARY outcome

Timeframe: Primary hospitalization for planned CABG.

Population: The data of all patients initially included in the study were analyzed.

The results were obtained from the analysis of primary data.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Length of Hospital Stay. Length of Stay in the Intensive Care Unit. Hospital Stay	38.4 days Standard Deviation 15.2	36.8 days Standard Deviation 11.2	32.8 days Standard Deviation 13.9
Length of Hospital Stay. Length of Stay in the Intensive Care Unit. Days in the intensive care unite	3.3 days Standard Deviation 1.8	3.9 days Standard Deviation 2.2	3.1 days Standard Deviation 1.7

PRIMARY outcome

Timeframe: The parameters were evaluated initially at baseline in the postoperative period - an interval of 0-6 hours, 12-18 hours, 18-24 hours, 48 hours, 72 hours, 96 hours, 7 days and 14 days.

Population: The data of all patients initially included in the study were analyzed.

Assessment of the severity of the systemic inflammatory response during hospital stay after surgery. Assessment of the level of inflammation by the severity of an increase in leukocytes (leukocytosis). Leukocytosis - an increase in the number of leukocytes per unit volume of blood. The norm of leukocytes in the blood is 5.5-8.810\^9 /l. For adults, leukocytosis is considered to be an increase in the number of leukocytes in the blood of more than 9.0\*10\^9 / l In the statistical analysis, the grouping of indicators in the indicated intervals was used, in view of the individual characteristics of the course of the postoperative period in each case.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). Leu (leukocytes) / initially	7.3 x10^9 cells/L" Standard Deviation 2.04	8.3 x10^9 cells/L" Standard Deviation 2.2	6.5 x10^9 cells/L" Standard Deviation 1.5
The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). Leu / in the postoperative period - an interval of 0-6 hours	16.2 x10^9 cells/L" Standard Deviation 5.4	13.9 x10^9 cells/L" Standard Deviation 6.3	14.1 x10^9 cells/L" Standard Deviation 1.9
The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). Leu / in the postoperative period - an interval of 12-18 hours	13.3 x10^9 cells/L" Standard Deviation 3.7	13.9 x10^9 cells/L" Standard Deviation 3.99	14.7 x10^9 cells/L" Standard Deviation 5.9
The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). Leu / in the postoperative period - an interval of 18-24 hours	16.99 x10^9 cells/L" Standard Deviation 3.9	13.08 x10^9 cells/L" Standard Deviation 2.4	15.4 x10^9 cells/L" Standard Deviation 2.4
The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). Leu / in the postoperative period 48 hours	13.3 x10^9 cells/L" Standard Deviation 3.97	13.8 x10^9 cells/L" Standard Deviation 5.5	14.8 x10^9 cells/L" Standard Deviation 2.2
The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). Leu / in the postoperative period 72 hours	11.4 x10^9 cells/L" Standard Deviation 1.9	11.3 x10^9 cells/L" Standard Deviation 4.1	9.4 x10^9 cells/L" Standard Deviation 1.6
The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). Leu / in the postoperative period 96 hours	10.4 x10^9 cells/L" Standard Deviation 1.99	10.1 x10^9 cells/L" Standard Deviation 2.7	8.7 x10^9 cells/L" Standard Deviation 2.6
The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). Leu / in the postoperative period 7 days	10.4 x10^9 cells/L" Standard Deviation 3.2	11.9 x10^9 cells/L" Standard Deviation 5.9	9.5 x10^9 cells/L" Standard Deviation 2.3
The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). Leu / in the postoperative period 14 days	10.4 x10^9 cells/L" Standard Deviation 3.06	8.8 x10^9 cells/L" Standard Deviation 1.6	8.8 x10^9 cells/L" Standard Deviation 1.7

PRIMARY outcome

Timeframe: Initial data, control point in the interval 4-6 days of the postoperative period, control point in the interval 12-14 days of the postoperative period.

Population: The data of all patients initially included in the study were analyzed.

Results of dynamic control of laboratory parameters of CRP. C-reactive protein. This fraction of plasma proteins increases in the presence of an inflammatory process in the body. It is synthesized in response to the ingestion of toxins of pathological microorganisms into the bloodstream and neutralizes them by binding them. In addition, it appears when the body's own cells are destroyed in the event of necrosis, tumor disintegration or extensive trauma, inactivating the resulting products. In addition to eliminating toxins, CRP triggers a cascade of immune responses aimed at eliminating pathologically altered structures. Normally absent (or less than 0.4 mg / l). In the statistical analysis, the grouping of indicators in the indicated intervals was used, in view of the individual characteristics of the course of the postoperative period in each case.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Assessment of the Degree of General Inflammatory Response (C-reactive Protein (CRP)), CRP initially/ mg / l	5.1 mg/l Standard Deviation 5.1	4.4 mg/l Standard Deviation 6.05	3.05 mg/l Standard Deviation 2
Assessment of the Degree of General Inflammatory Response (C-reactive Protein (CRP)), CRP control point in the interval 4-6 days of the postoperative period/ mg/l	121.1 mg/l Standard Deviation 76.3	80.2 mg/l Standard Deviation 38	85.9 mg/l Standard Deviation 51.8
Assessment of the Degree of General Inflammatory Response (C-reactive Protein (CRP)), CRP control point in the interval 12-14 days of the postoperative period/ mg/l	24.4 mg/l Standard Deviation 15.6	24.6 mg/l Standard Deviation 13.8	25.9 mg/l Standard Deviation 20.9

PRIMARY outcome

Timeframe: Evaluation of these data - for the time spent in the intensive care unit before removing the drains.

Population: The data of all patients initially included in the study were analyzed.

A daily assessment of the discharge by drainage before removal was carried out. It was carried out to assess the possible development of an excessive inflammatory reaction (polyserositis phenomena) in response to the transplantation of autologous bone marrow mononuclear cells.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
The Volume of Discharge Through the Drains in the Early Postoperative Period. The volume of discharge through the drains on the first day after surgery.	410 milliliters Standard Error 59.4	541.2 milliliters Standard Error 47.9	424 milliliters Standard Error 95.7
The Volume of Discharge Through the Drains in the Early Postoperative Period. The volume of discharge through the drains on the second day after the operation.	195.4 milliliters Standard Error 33.6	189.7 milliliters Standard Error 27.1	152 milliliters Standard Error 54.2

PRIMARY outcome

Timeframe: 1 and 3 days of the postoperative period.

Population: The data of all patients initially included in the study were analyzed.

Assessment of the severity of the period of ischemia / reperfusion. And the effect of autologous bone marrow mononuclear cells transplantation on these indicators.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin). Troponin I (postoperative day 1)/mcg / l	2.9 mcg / l Standard Deviation 2.3	12.05 mcg / l Standard Deviation 18.9	5.7 mcg / l Standard Deviation 5.8
Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin). Troponin I (postoperative day 3)/mcg / l	1.9 mcg / l Standard Deviation 1.3	19.6 mcg / l Standard Deviation 31.9	3.08 mcg / l Standard Deviation 3.7
Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin). Myoglobin postoperative day 1/mcg / l/	757.2 mcg / l Standard Deviation 1146.8	522.8 mcg / l Standard Deviation 711.6	385.6 mcg / l Standard Deviation 221.7
Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin). Myoglobin postoperative day 3/mcg / l	70.4 mcg / l Standard Deviation 148.4	92.5 mcg / l Standard Deviation 1094.8	71.4 mcg / l Standard Deviation 41.4

PRIMARY outcome

Timeframe: 1 and 3 days of the postoperative period.

Population: The data of all patients initially included in the study were analyzed.

Assessment of the severity of the period of ischemia / reperfusion. And the effect of autologous bone marrow mononuclear cells transplantation on these indicators.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Dynamics of Markers of Myocardial Damage (Creatine Phosphokinase Fraction MB (CPK-MB)). CPK-MB postoperative day 1/ U/l	78.6 U/l Standard Deviation 136.8	62.3 U/l Standard Deviation 1024	63.02 U/l Standard Deviation 79.2
Dynamics of Markers of Myocardial Damage (Creatine Phosphokinase Fraction MB (CPK-MB)). CPK-MB postoperative day 3/ U/l	4.6 U/l Standard Deviation 1.9	35.4 U/l Standard Deviation 84.7	9.5 U/l Standard Deviation 9.3

PRIMARY outcome

Timeframe: Intraoperative data.

Population: The data of all patients initially included in the study were analyzed.

These parameters were evaluated at the end of the cardiopulmonary bypass and at the end of the surgery. The interval between indicators is on average from 60 to 120 minutes.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Intraoperative Assessment of Homeostasis (Hemoglobin (Hb). Hb intraoperatively before turning off the cardiopulmonary bypass (CPB).	75.8 g/l Standard Deviation 14.5	74.05 g/l Standard Deviation 12.2	73.4 g/l Standard Deviation 8.08
Intraoperative Assessment of Homeostasis (Hemoglobin (Hb). Hb at the end of the operation.	86.7 g/l Standard Deviation 11.1	91.3 g/l Standard Deviation 16.09	91.5 g/l Standard Deviation 8.6

PRIMARY outcome

Timeframe: Intraoperative data.

Population: The data of all patients initially included in the study were analyzed.

These parameters were evaluated at the end of the cardiopulmonary bypass and at the end of the surgery. The interval between indicators is on average from 60 to 120 minutes.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Intraoperative Assessment of Homeostasis (Hematocrit (HCT)). HCT intraoperatively before turning off the cardiopulmonary bypass(CPB).	23.2 percent Standard Deviation 3.9	23.4 percent Standard Deviation 4.2	22.2 percent Standard Deviation 1.9
Intraoperative Assessment of Homeostasis (Hematocrit (HCT)). HCT at the end of the operation.	25.7 percent Standard Deviation 3.1	29.3 percent Standard Deviation 5.2	27.8 percent Standard Deviation 3.2

PRIMARY outcome

Timeframe: Intraoperative data.

Population: The data of all patients initially included in the study were analyzed.

These parameters were evaluated at the end of the cardiopulmonary bypass and at the end of the surgery. The interval between indicators is on average from 60 to 120 minutes.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Intraoperative Assessment of Homeostasis (К+). K+ intraoperatively before turning off the cardiopulmonary bypass(CPB).	4.7 mmol/l Standard Deviation 0.9	5.01 mmol/l Standard Deviation 0.59	5.4 mmol/l Standard Deviation 0.9
Intraoperative Assessment of Homeostasis (К+). K+ at the end of the operation.	3.9 mmol/l Standard Deviation 0.5	3.9 mmol/l Standard Deviation 0.4	4.5 mmol/l Standard Deviation 0.6

PRIMARY outcome

Timeframe: Intraoperative data.

Population: The data of all patients initially included in the study were analyzed.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Cardiopulmonary Bypass Time.	144 minutes Standard Deviation 29.2	135 minutes Standard Deviation 31.6	122.8 minutes Standard Deviation 19.7

PRIMARY outcome

Timeframe: Intraoperative data.

Population: The data of all patients initially included in the study were analyzed.

Estimation of the time from the moment the clamp is applied to the aorta (complete clamping of the aorta) to the removal of the clamp from the aorta.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Time of Aortic Clamping (Anoxia).	84 minutes Standard Deviation 18.8	75.8 minutes Standard Deviation 17.6	73.8 minutes Standard Deviation 22.3

PRIMARY outcome

Timeframe: Postoperative period.

Population: The data of all patients initially included in the study were analyzed.

The presence of complications in the postoperative period (Hydrothorax, Hydropericardium, Cardiac arrhythmias - atrial fibrillation / atrial flutter).

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. Hydrothorax / postoperative period	3 participants	3 participants	4 participants
Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. Hydropericardium / postoperative period	2 participants	0 participants	1 participants
Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. Resternotomy / postoperative period	0 participants	1 participants	1 participants
Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. Atrial fibrillation / postoperative period	9 participants	8 participants	4 participants
Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. Atrial flutter / postoperative period	0 participants	4 participants	0 participants

PRIMARY outcome

Timeframe: 7-14 days of the postoperative period

Population: all patients included in the study

Evaluation of myocardial contractility according to echocardiography, in particular the left ventricular ejection fraction, was carried out within 7-14 days of the postoperative period, depending on the patient's clinical condition, as well as the maximum degree of information content of this study. The lower the indicator, the worse the prognosis of an unfavorable outcome.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Left Ventricular Ejection Fraction - Echocardiography - Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety.	55.9 percent Standard Deviation 2.1	62.1 percent Standard Deviation 1.6	56.4 percent Standard Deviation 2.0

PRIMARY outcome

Timeframe: 7-14 days after surgery

Population: All patients included in the study.

Assessment of myocardial contractility according to echocardiography, in particular the size of the left ventricle - its index, was carried out within 7-14 days of the postoperative period, depending on the clinical condition of the patient, as well as on the maximum information content of this study. The higher the indicator (left ventricular size - index), the worse the prognosis of an unfavorable outcome. The index is used as an indicator of payment to obtain a more reliable result (taking into account the individual characteristics of each patient). index - left ventricular size (mm.)/ body mass index (kg/m\^2).

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment - Echocardiography (Size of the Left Ventricle - Index). Additional Estimation of Safety. Lvd ind.	2.7 mm/m^2 Standard Deviation 0.1	2.6 mm/m^2 Standard Deviation 0.08	3 mm/m^2 Standard Deviation 0.1
Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment - Echocardiography (Size of the Left Ventricle - Index). Additional Estimation of Safety. Lvs ind.	1.9 mm/m^2 Standard Deviation 0.09	1.8 mm/m^2 Standard Deviation 0.07	2.1 mm/m^2 Standard Deviation 0.09
Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment - Echocardiography (Size of the Left Ventricle - Index). Additional Estimation of Safety. LAind.	2.1 mm/m^2 Standard Deviation 0.08	2 mm/m^2 Standard Deviation 0.06	2.2 mm/m^2 Standard Deviation 0.07

PRIMARY outcome

Timeframe: 7-14 days after surgery

Population: All patients included in the study

Evaluation of myocardial contractility according to echocardiography, in particular volume of the left ventricle - index was carried out within 7-14 days of the postoperative period, depending on the patient's clinical condition, as well as the maximum degree of information content of this study. The greater the figure (volume of the left ventricle - index), the worse the prognosis of adverse outcome. The index is used as an indicator of the payment to obtain a more reliable result (taking into account individual characteristics of each patient). index - volume of the left ventricle (ml.)/ body mass index (kg / m\^2).

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Volume of the Left Ventricle - Index - Echocardiography. Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety. LVEDV MOD BP ind	63.9 mL/m^2 Standard Deviation 5.9	58.8 mL/m^2 Standard Deviation 4.8	70.9 mL/m^2 Standard Deviation 6.9
Volume of the Left Ventricle - Index - Echocardiography. Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety. LVESV MOD BP ind.	27.8 mL/m^2 Standard Deviation 3.7	23.5 mL/m^2 Standard Deviation 3	31.9 mL/m^2 Standard Deviation 4.4

PRIMARY outcome

Timeframe: Upon completion of the main stage of surgery.

Population: All patients included in the study.

The need to perform defibrillation to restore sinus rhythm, at the end of the main stage of surgery.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Restoration of the Heart Rate After the Completion of the Main Stage of the Surgical Intervention. Additional Estimation of Safety.	4 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 12 months after surgery

Population: All patients included in the study (groups 1 and 2) were compared with the control group (Group 0).In patients included in study during the observation period after the treatment there was no progression of the underlying disease that was fatal.

The total number of deaths - in the primary hospitalization and during the observation period of 12 months after surgical treatment - deaths associated with the progression of the initial disease. The complication rate for CABG operations is 30±10%. According to n1=kn2; n1 sample size, in the control. In group 0, k=2/3 times more than in group 1 and group 2. The difference between the test and control frequencies is ε=p1-p2. Accordingly, with p1 = 0.2; p2=0.4, δ= 0.1; n1=49.5, n2=33. The result is group 0 - 36, group 1 and 2 - 25+25 = 50. The null hypothesis of complication rate δ.All patients included in the study.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
All-cause Mortality Associated With the Progression of Basic Disease.	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: At baseline and after one year.

Population: All patients included in the study.

The SF-36 questionnaire. The indicators of each scale vary between 0 and 100, where 100 represents total health. The results are presented in the form of scores on 8 scales, compiled in such a way that a higher score indicates a higher level of quality of life.MHFLQ - for patients with heart failure.The specified questionnaire consists of 21 questions. To answer each question, a scale of 6 points from the minimum intensity of certain symptoms to the maximum is used. The assessment is based on the sum of points, where the maximum number of points - 105 corresponds to the patient's worst condition. The lowest score 0 points is the best clinical condition of the patient. SAQ consists of 19 questions about the patient's condition, which are divided into the following 5 scales. The quality of life for each of the five scales under consideration is measured in percent, with 0% corresponding to the worst quality of life, and 100% to the best.

Outcome measures

SECONDARY outcome

Timeframe: up to 12 months

Population: Data analysis of all patients underwent follow-up examination 12 months after surgery.

1. functional class - The usual load does not cause changes in the state of health. Painful attacks occur against the background of excessive loads - after climbing several flights of stairs, while walking fast. 2. functional class - Pain attacks when walking more than 500 meters, when climbing stairs more than one floor. 3. functional class - The patient does not tolerate minimal physical activity. An attack occurs when walking a distance of 50-100 meters. Climbing stairs is difficult. 4. functional class - Activity is significantly limited. Angina pectoris manifests itself when performing minimal actions, including at rest.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment. 1 functional class of angina pectoris1 year after	5 participants	15 participants	4 participants
Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment. 2 functional class of angina pectoris1 year after	0 participants	7 participants	0 participants
Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment. 3 functional class of angina pectoris1 year after	0 participants	0 participants	0 participants
Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment. 4 functional class of angina pectoris1 year after	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Assessment of the dynamics at 12 months after treatment.

Population: In one case, a patient of Groups 1 through 12 months after the treatment, marked progression of the functional class of heart failure. It should be noted that this patient did not adhere to the recommendations on lifestyle and drug therapy in the postoperative period.

1. functional class - There is no limitation of a person's physical activity, shortness of breath manifests itself when going above the third floor. 2. functional class - slight limitation of activity, palpitations, shortness of breath, fatigue occur during normal physical activity and more. 3. functional class - Symptoms occur with the smallest physical activity, resulting in a significant decrease in activity. At rest, clinical manifestations are not observed. The smaller the functional class, the better the quality of human life.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Dynamics of the Functional Class of Heart Failure (NYHA). Estimation of Efficiency. 1 functional class heart failure (NYHA).	7 Participants	12 Participants	14 Participants
Dynamics of the Functional Class of Heart Failure (NYHA). Estimation of Efficiency. 2 functional class heart failure (NYHA).	15 Participants	25 Participants	10 Participants
Dynamics of the Functional Class of Heart Failure (NYHA). Estimation of Efficiency. 3 functional class heart failure (NYHA).	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 months after treatment.

Population: All patients included in the study.

According to echocardiography.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Evaluation of the Left Ventricular Ejection Fraction 12 Months After Treatment.	58.4 percent Standard Deviation 1.9	61.4 percent Standard Deviation 1.5	58.1 percent Standard Deviation 1.8

SECONDARY outcome

Timeframe: 12 months after the treatment.

Population: The data of all patients initially included in the study were analyzed.

Evaluation of myocardial contractility according to echocardiography, in particular the size of the left ventricle - the index was carried out 12 months after CABG. The higher the indicator (left ventricular size - index), the worse the prognosis of an unfavorable outcome. The index is used as an indicator of the payment to obtain a more reliable result (taking into account individual characteristics of each patient). index - size of the left ventricle (mm.)/ body mass index (kg/m\^2).

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Estimation of the Index of Linear Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. Lvd ind.	2.8 mm/m^2 Standard Deviation 0.09	2.7 mm/m^2 Standard Deviation 0.07	2.9 mm/m^2 Standard Deviation 0.08
Estimation of the Index of Linear Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. Lvs ind.	1.8 mm/m^2 Standard Deviation 0.08	1.9 mm/m^2 Standard Deviation 0.06	2.07 mm/m^2 Standard Deviation 0.08
Estimation of the Index of Linear Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. LAind.	2.2 mm/m^2 Standard Deviation 0.07	2.2 mm/m^2 Standard Deviation 0.05	2.3 mm/m^2 Standard Deviation 0.07

SECONDARY outcome

Timeframe: 12 Months After the Treatment

Population: The data of all patients initially included in the study were analyzed.

Evaluation of myocardial contractility according to echocardiography, in particular the volume of the left ventricle - the index was carried out 12 months after CABG. The higher the indicator (left ventricular volume - index), the worse the prognosis of an unfavorable outcome. The index is used as an indicator of the payment to obtain a more reliable result (taking into account individual characteristics of each patient). index - volume of the left ventricle (mm.)/ body mass index (kg/m\^2).

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Estimation of the Index of Volumetric Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. LVEDV MOD BP ind.	66.9 mL/m^2 Standard Deviation 5.5	62.3 mL/m^2 Standard Deviation 4.4	70.4 mL/m^2 Standard Deviation 6.2
Estimation of the Index of Volumetric Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. LVESV MOD BP ind.	25.6 mL/m^2 Standard Deviation 3.5	25.2 mL/m^2 Standard Deviation 2.6	31.5 mL/m^2 Standard Deviation 3.9

SECONDARY outcome

Timeframe: 12 months after treatment.

Population: The data of all patients initially included in the study were analyzed.

Evaluation of left ventricular diastolic function (echocardiography). The peak velocity E reflects the pressure gradient between the LA and LV in early diastole, and it is affected by preload and disturbance LV relaxation The speed of peak A, which forms at the end diastole, influences LV compliance and contractility left atrium.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Assessment of Left Ventricular Diastolic Function - Peak E of Transmitral Flow and Peak А of Transmitral Flow 12 Months After Treatment. Peak E of transmitral flow	0.8 meters/sec. Standard Deviation 0.05	0.7 meters/sec. Standard Deviation 0.04	0.7 meters/sec. Standard Deviation 0.05
Assessment of Left Ventricular Diastolic Function - Peak E of Transmitral Flow and Peak А of Transmitral Flow 12 Months After Treatment. Peak А of transmitral flow	0.8 meters/sec. Standard Deviation 0.1	0.7 meters/sec. Standard Deviation 0.09	07 meters/sec. Standard Deviation 0.1

SECONDARY outcome

Timeframe: 12 months after treatment

Population: All patients included in the study.

The ratio of the transmitral flow, wave E (ejection wave / left ventricular contraction) to wave A (ejection wave / left atrial contraction). The norm is 0.75-1.5 Less than 0.75 violation of relaxation, more than 1.5 restrictive type of diastolic dysfunction.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Assessment of Left Ventricular Diastolic Function E/A - 12 Months After Treatment.	1.2 ratio Standard Deviation 0.1	1 ratio Standard Deviation 0.1	1.2 ratio Standard Deviation 0.1

SECONDARY outcome

Timeframe: 12 Months After Treatment.

Population: The data of all patients initially included in the study were analyzed.

Echocardiographic data ( DT (Half-time of wave E), time of isovolumic relaxation of the left ventricle (IVRT). DT (Half-time of wave E). The DT time index reflects the relaxation process LV, LV diastolic pressure after mitral valve opening, and LV compliance. 150-200 ms - normal; \> 200 ms - violation of relaxation; 150-200 ms - pseudonormal type of left ventricular filling; \<150 ms - restrictive type of diastolic dysfunction IVRT (time of isovolumic relaxation of the left ventricl.) \<100 ms - normal; \> 100 ms - violation of relaxation

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Assessment of Left Ventricular Diastolic Function - DT and IVRT 12 Months After Treatment. DT (Half-time of wave E).	256.6 ms Standard Deviation 18.3	250.4 ms Standard Deviation 15.2	252.6 ms Standard Deviation 20.08
Assessment of Left Ventricular Diastolic Function - DT and IVRT 12 Months After Treatment. time of isovolumic relaxation of the left ventricle (IVRT).	99.6 ms Standard Deviation 4.9	96.9 ms Standard Deviation 4.1	102.4 ms Standard Deviation 5.5

SECONDARY outcome

Timeframe: initially and after 12 months

The dynamic of the number of meters walked according to the 6-minutes walk test (6MWD) in the observation groups.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Distance Traveled in the 6-minute Walk Test. Test Results With 6 Minute Walk Original number of meters.	329.9 meters Standard Deviation 25.3	315.06 meters Standard Deviation 17.6	319.8 meters Standard Deviation 24.5
Distance Traveled in the 6-minute Walk Test. Test Results With 6 Minute Walk Number of meters in 12 months.	452.7 meters Standard Deviation 29.7	433.54 meters Standard Deviation 20.6	524.4 meters Standard Deviation 28.7

SECONDARY outcome

Timeframe: up to 12 months

Population: All patients included in the study.

According to the angiographic study.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
The Number of Functioning Grafts 12 Months After CABG. Patency of Grafts Within a Specified Time of Treatment (Angiography). Initial number of grafts	75 Number of grafts	113 Number of grafts	79 Number of grafts
The Number of Functioning Grafts 12 Months After CABG. Patency of Grafts Within a Specified Time of Treatment (Angiography). Number of functioning grafts at 12 months	73 Number of grafts	99 Number of grafts	76 Number of grafts
The Number of Functioning Grafts 12 Months After CABG. Patency of Grafts Within a Specified Time of Treatment (Angiography). Number of non-functioning grafts after 12 months	2 Number of grafts	14 Number of grafts	3 Number of grafts

SECONDARY outcome

Timeframe: up to 12 months

Population: All patients included in the study.

Echocardiographic data.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Analysis of the Effect of Left Ventricular Diastolic Dysfunction on the Patency of the Grafts. Number of patients with non-functioning grafts	2 Participants	10 Participants	1 Participants
Analysis of the Effect of Left Ventricular Diastolic Dysfunction on the Patency of the Grafts. Patients with non-functioning grafts in the presence of LV diastolic dysfunction after 12 months.	1 Participants	8 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Initial data at the time of collection of bone marrow cells.

Population: The data of all patients initially included in the study were analyzed.

Dependence and Duration of Positive Clinical Effect on the Amount of Injected Cell Material (cytosis).

Outcome measures

Outcome measures
Measure	Group 2 Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=23 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
The Volume of Cellular Material (Cytosis).	—	20.3 *10^8cells/l Standard Deviation 8.9	20.3 *10^8cells/l Standard Deviation 8.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Initial data at the time of collection of bone marrow cells.

Population: The data of all patients initially included in the study were analyzed.

Dependence and duration of positive clinical effect on the amount of injected cell material (Mononuclear fraction %, CD34+ %, CD133+ %). Assessment - mononuclear fraction, CD 34 +, CD 133+ according to flow cytometry data.

Outcome measures

Outcome measures
Measure	Group 2 Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=23 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
The Amount of Cell Material (Percentage). Mononuclear fraction/ %	—	21.04 percent Standard Deviation 2.9	20.0 percent Standard Deviation 2.7
The Amount of Cell Material (Percentage). CD34+/ %	—	1.16 percent Standard Deviation 0.22	1.18 percent Standard Deviation 0.34
The Amount of Cell Material (Percentage). CD133+/ %	—	0.4 percent Standard Deviation 0.08	0.38 percent Standard Deviation 1.14

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months after treatment.

Population: The data of all patients initially included in the study were analyzed.

The distance covered (in meters) was compared with the proper value depending on age (years), height (cm), weight (kg), body mass index (BMI). The due values (6MWD (i)) were calculated using the following formulas: For men: 6МWD (i) = 7.57 × height - 5.02 × age - 1.76 × weight - 309 or 6MWD (i) = 1140 - 5.61 × BMI - 6.94 × age. For women: 6МWD (i) = 2.11 × height - 2.29 × weight - 5.78 × age + 667 Or 6МWD (i) = 1017 - 6.24 × BMI - 5.83 × age. This difference at baseline is reported as distance walked for smokers minus non-smokers.

Outcome measures

Outcome measures
Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Smoking as a Factor That Negatively Affects the Results of the Test With a 6-minute Walk in Dynamics. diference between smokers and non-smoking participants at baseline	224.8 meters Standard Deviation 27.1	230.04 meters Standard Deviation 28.7	215.3 meters Standard Deviation 31.4
Smoking as a Factor That Negatively Affects the Results of the Test With a 6-minute Walk in Dynamics. diference between baseline and1 year after surgery	62.1 meters Standard Deviation 4.8	87.9 meters Standard Deviation 4.9	8.5 meters Standard Deviation 2.7

Adverse Events

Group 0

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vladimir V Komok, Ph.D

First Pavlov State Medical University of St. Petersburg

Phone: 8-904-632-19-00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group 2 n=23 Participants Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.	Group 0 n=37 Participants Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.	Group 1 n=25 Participants Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. Physical Functioning SF-36	51.1 score on a scale Standard Deviation 6.2	48.6 score on a scale Standard Deviation 4.6	47.8 score on a scale Standard Deviation 6.2
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. Physical Functioning SF-36 in year	68.6 score on a scale Standard Deviation 5.4	62.9 score on a scale Standard Deviation 4	69.2 score on a scale Standard Deviation 5.4
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. Role-Physical Functioning SF-36	21 score on a scale Standard Deviation 8.4	24.2 score on a scale Standard Deviation 6.2	20.8 score on a scale Standard Deviation 8.4
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. Role-Physical Functioning SF-36 in year	43.06 score on a scale Standard Deviation 10	38.7 score on a scale Standard Deviation 7.4	41.7 score on a scale Standard Deviation 10
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. Bodily pain SF-36	57.8 score on a scale Standard Deviation 6.7	50.9 score on a scale Standard Deviation 4.9	53.3 score on a scale Standard Deviation 6.7
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. Bodily pain SF-36 in year	73.4 score on a scale Standard Deviation 6.04	68 score on a scale Standard Deviation 4.5	75.8 score on a scale Standard Deviation 6.04
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. General Health SF-36	45 score on a scale Standard Deviation 3.4	48.6 score on a scale Standard Deviation 2.5	50.1 score on a scale Standard Deviation 3.4
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. General Health SF-36 in year	53.5 score on a scale Standard Deviation 3.3	52.4 score on a scale Standard Deviation 2.4	53.2 score on a scale Standard Deviation 3.3
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. Vitality SF-36	53.8 score on a scale Standard Deviation 4.9	52.6 score on a scale Standard Deviation 3.7	54.7 score on a scale Standard Deviation 4.9
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. Vitality SF-36 in year	64.7 score on a scale Standard Deviation 3.6	61.3 score on a scale Standard Deviation 2.6	67.2 score on a scale Standard Deviation 3.6
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. Social Functioning SF-36	66.3 score on a scale Standard Deviation 5.7	66.4 score on a scale Standard Deviation 4.2	65.9 score on a scale Standard Deviation 5.7
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. Social Functioning SF-36 in year	82.6 score on a scale Standard Deviation 5.2	77.8 score on a scale Standard Deviation 3.9	77.08 score on a scale Standard Deviation 5.2
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. Role- Emotional SF-36	38.3 score on a scale Standard Deviation 9.7	51.5 score on a scale Standard Deviation 7.2	40.7 score on a scale Standard Deviation 9.7
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. Role- Emotional SF-36 in year	55.5 score on a scale Standard Deviation 10.2	58.6 score on a scale Standard Deviation 7.6	53.7 score on a scale Standard Deviation 10.2
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. Mental Health SF-36	67.5 score on a scale Standard Deviation 4.2	60.6 score on a scale Standard Deviation 3.1	64.9 score on a scale Standard Deviation 4.2
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. Mental Health SF-36 in year	72.7 score on a scale Standard Deviation 3.98	64.5 score on a scale Standard Deviation 2.9	70 score on a scale Standard Deviation 3.98
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. Minnesota Quality of Life (MHFLQ)	33.3 score on a scale Standard Deviation 4.9	39.8 score on a scale Standard Deviation 3.6	35.1 score on a scale Standard Deviation 4.9
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. Minnesota Quality of Life (MHFLQ) in year	22.1 score on a scale Standard Deviation 3.9	31.6 score on a scale Standard Deviation 2.9	22.7 score on a scale Standard Deviation 3.9
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. Seattle QuestionnairePhysical limitation	40 score on a scale Standard Deviation 5.2	39.6 score on a scale Standard Deviation 3.5	42.6 score on a scale Standard Deviation 5.4
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. SeattleQuestionnairePhysical limitation / in year	58.6 score on a scale Standard Deviation 4.3	53.5 score on a scale Standard Deviation 2.9	60.8 score on a scale Standard Deviation 4.4
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. SeattleQuestionnaireAngina stability	61 score on a scale Standard Deviation 9.4	43.5 score on a scale Standard Deviation 6.3	40.4 score on a scale Standard Deviation 9.7
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. SeattleQuestionnaireAngina stability / in year	98.2 score on a scale Standard Deviation 10.6	87 score on a scale Standard Deviation 7.1	91.9 score on a scale Standard Deviation 10.9
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. SeattleQuestionnaireAngina frequency	46.07 score on a scale Standard Deviation 8.5	48.7 score on a scale Standard Deviation 5.7	48.5 score on a scale Standard Deviation 8.8
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. SeattleQuestionnaiAngina frequency / in year	86.4 score on a scale Standard Deviation 6.3	80.3 score on a scale Standard Deviation 4.2	90.8 score on a scale Standard Deviation 6.6
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. SeattleQuestionnaireTreatment satisfaction	69.6 score on a scale Standard Deviation 5.6	58.9 score on a scale Standard Deviation 3.7	72.1 score on a scale Standard Deviation 5.8
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. SeattleQuestionnaireTreatmentSatisfaction/ in year	80.4 score on a scale Standard Deviation 4.8	75.2 score on a scale Standard Deviation 3.2	81.3 score on a scale Standard Deviation 4.9
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. SeattleQuestionnaire Disease perception	37.9 score on a scale Standard Deviation 6.5	41.4 score on a scale Standard Deviation 4.3	36.5 score on a scale Standard Deviation 6.7
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. SeattleQuestionnaire Disease perception/ in year	64.3 score on a scale Standard Deviation 20.1	60.7 score on a scale Standard Deviation 24.4	64.2 score on a scale Standard Deviation 20.8