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

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

Status and phase: Terminated; Phase 1

Conditions: Heart Failure

Treatments: Procedure: NOGA XP Cardiac Navigation System

Study type: Interventional

Funder types: Other

Identifiers

NCT01354678

IMPI-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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15 participants in 2 patient groups

group of bone marrow cell therapy

Active Comparator group

Treatment:

Procedure: NOGA XP Cardiac Navigation System

Procedure: NOGA XP Cardiac Navigation System

group of sham therapy

Sham Comparator group

Treatment:

Procedure: NOGA XP Cardiac Navigation System

Procedure: NOGA XP Cardiac Navigation System