Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia

Phase 1TerminatedNCT01354678

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health15 enrolled

Overview

Randomised placebo-controlled study of efficiency and safety of bone marrow mononuclear cells transplantation by intramyocardial multiple precision injection in ischemic heart failure patients.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Heart Failure

Interventions

NOGA XP Cardiac Navigation SystemPROCEDURE

Intramyocardial multiple precision injection of bone marrow mononuclear cells

NOGA XP Cardiac Navigation SystemPROCEDURE

Intramyocardial multiple precision injection with placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

Almazov Federal National Medical Research Centre

Saint Petersburg, Russia

Outcomes

Primary Outcomes

Change in global left ventricular ejection fraction and regional wall motion score index

Time frame: 6 and12 months

Secondary Outcomes

Incidence of the major adverse cardiac events

Time frame: 6 and 12 months

Data from ClinicalTrials.gov

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