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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2018-01-31

Brief Summary

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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).

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Potential participants in this study were all patients admitted for planned coronary artery bypass grafting under extracorporeal circulation and who, according to angiographic examination, had 3 or more stenotic coronary arteries. The final decision on the inclusion of each individual patient in this study was determined taking into account the inclusion criteria. The study was conducted according to the approved protocol as a randomized, blind, placebo controlled.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Randomization into three observation groups was carried out according to the table of random numbers.

Study Groups

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Group 1

Intramyocardial administration of autologous bone marrow mononuclear cells during the operation coronary artery bypass grafting 0.2 ml - 10 injection in the zone of blood supply LAD.

Group Type ACTIVE_COMPARATOR

Group 1

Intervention Type PROCEDURE

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.

Group 0

Intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD during the operation coronary artery bypass grafting.

Group Type PLACEBO_COMPARATOR

Group 0

Intervention Type PROCEDURE

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.

Group 2

Intramyocardial and intracoronary administration of autologous bone marrow mononuclear cells during coronary artery bypass grafting intramyocardial 0.2 ml - 10 injection in the zone of blood supply LAD.

Group Type ACTIVE_COMPARATOR

Group 2

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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CABG with intramyocardial administration of ABMMC. CABG with administration of 0.9 % sodium chlorid. CABG with intramyocardial and intracoronary administration of ABMMC.

Eligibility Criteria

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Inclusion Criteria

* Men and women from 18 to 80 years
* Patients with angina pectoris III-IV functional class
* According to angiographic examination, the presence of 3 or more stenotic coronary arteries
* Aorto-coronary bypass surgery under cardiopulmonary bypass
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No