Heart Failure
Conditions
Keywords
heart failure, bone marrow mononuclear cells
Brief summary
Randomised placebo-controlled study of efficiency and safety of bone marrow mononuclear cells transplantation by intramyocardial multiple precision injection in ischemic heart failure patients.
Detailed description
The increase of prevalence of heart failure in human population requires to develop new and effective methods of treatment. One of them is stem cells transplantation into a myocardial tissue, which cause the improvement of contractility, myocardial remodelling after myocardial infarction (MI), dilated cardiomyopathy, etc. Use of autologous stem cells does not require of immunosuppressive therapy and does not correlate with some ethical problems. Clinical application of mesenchymal stem cells always requires a step of culturing, which is associated with increased risk of contamination Therefore haemopoietic stem cells, endothelial progenitor cells or mononuclear bone marrow cells are often used to be transplant for treatment of heart failure (HF) patients.Using NOGA XP Cardiac Navigation System improves specificity of transplantations, that is decisive.
Interventions
PROCEDURENOGA XP Cardiac Navigation System
Intramyocardial multiple precision injection of bone marrow mononuclear cells
Sponsors
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* patients with coronary artery disease (CAD) and HF II-III NYHA class * MI more than 6 months before the study * LVEF less than 35% * absence of indication to coronary revascularization * optimal pharmacological therapy no less than 8 weeks * heart transplantation is contraindicated * patients with implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) * patients giving informed consent
Exclusion criteria
* acute coronary syndrome * coronary revascularization less than 6 months * patients requiring surgical correction of post-MI aneurism * LV wall thickness less than 5 mm in site of possible injection * patients with CRT implanted within 3 month before cells injection * clinically significant associated diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in global left ventricular ejection fraction and regional wall motion score index | 6 and12 months |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of the major adverse cardiac events | 6 and 12 months |
Countries
Russia
Outcome results
None listed