Title
The Application of the Umbilical Cord Mesenchymal Stem Cells in the Complex Treatment of Non-ischemic Heart Failure
Optimization of the Complex Treatment of Nonischemic Dilated Cardiomyopathy Due to the Addition to the Standard Drug Therapy of Intracoronary Administration of Umbilical Cord-derived Mesenchymal Stromal Cells
Phase
Phase 2Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Chronic Heart Failure Non-ischemic Cardiomyopathy Non-ischemic Dilated CardiomyopathyIntervention/Treatment
Intracoronary administration of the umbilical cord-derived mesenchymal stromal cells ...Study Participants
30The purpose of this study is to optimize the complex treatment of chronic heart failure of non-ischemic etiology by supplementing umbilical cord mesenchymal stem cells to the standard drug therapy.
The purpose of this study is to optimize the complex treatment of non-ischemic dilated cardiomyopathy by supplementing the standard drug therapy with intracoronary administration of umbilical cord-derived mesenchymal stromal cells.
Sixty patients will be selected and randomly divided into the main and control groups in a 1: 1 ratio.
Patients of the main group will receive complex treatment based on the addition to the standard drug therapy of intracoronary administration of 10 million mesenchymal stromal cells of the umbilical cord, and patients of the control group will receive only standard drug therapy.
Every patient will maintain their standard treatment of chronic heart failure, with maximum tolerated dosage without side effects.
The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1,1-3 and 3-6 months.
Clinical results will be analyzed after completion of 6 months of followup.
Catheterization of the right and left heart cavities
After performing cardiac catheterization, selective coronary angiography will be performed abruptly to assess the condition of the coronary canal by access through the right radial or common femoral artery on the right after 70 U/kg of heparin iv. Then 20 ml of the finished suspension (1×10(7) umbilical cord-derived mesenchymal stromal cells diluted in 20 ml of heparinized saline) will be administrated into the mouth of the left coronary artery (LCA) without occlusion of the vessel with a balloon catheter and without stopping the coronary blood flow. Cell injection will be carried out using a standard 6 Fr catheter for selective coronary angiography with perfusion for 10 minutes at a volume rate of 2 ml/min, thereby introducing 1×10(6) cells per minute
Patients of the main group will undergo cardiac catheterization with intracoronary administration of 1×10 (7) umbilical cord-derived mesenchymal stromal cells and and will continue to receive optimal pharmacological therapy
Patients in the control group will only have cardiac catheterization and will continue to receive optimal pharmacological therapy
Inclusion Criteria: Men and women over 18 years of age, who are registered in the dispensary at the The Research-Clinical Center for Cardiac Surgery and Transplantology; The previously established clinical diagnosis of Dilated cardiomyopathy in the stage III-IV of New York Heart Association classification; Non-ischemic etiology of Dilated cardiomyopathy according to coronary angiography or computed tomography of the heart with contrast; Decreased contractile function of the heart the left ventricular ejection fraction ≤35% according to transthoracic echocardiography and computed tomography of the heart with contrast; Presence of automatic (implantable) cardiac defibrillator; Lack of laboratory and clinical data on dysfunctions or insufficiency of other internal organs; The absence of a history of cancer over the past 5 years and deviations according to the analysis of tumor markers; Signed voluntary informed consent to participate in the study. Exclusion Criteria: Coronary artery disease, previously undergone cardiac surgery, including stenting of the coronary arteries; The presence of clinically significant valve pathology, blood clots in the cavities of the heart, aneurysms of the left ventricle, hypertrophic, early postpartum, alcoholic or restrictive cardiomyopathy, congenital heart defects and resistant hypertension; A history of stroke in the past 2 years; A history of autoimmune and immunodeficiency diseases; Polyvalent allergy; Decompensation of concomitant chronic diseases; Reception of systemic corticosteroids, cytostatics, immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), as well as drugs that deplete DNA or cytotoxic drugs, the last intake of which was within four weeks before the study; Hepatitis B and / or C, syphilis, HIV-carriage or AIDS; The presence of acute systemic infections requiring targeted antibiotic therapy; A history of untreated peptic ulcer and bleeding from the gastrointestinal tract; The presence of early transferred closed and open craniocerebral injuries that have a clinical manifestation and require specialized treatment; A history of uncontrolled epileptic seizures; Porphyria; The need for hospitalization and treatment in a hospice; Alcohol and drug abuse, lack of permanent residence, severe depression, disorientation, distant living.
