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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 1 Study to Evaluate the Efficacy and Safety of Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia

Conditions
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Heart Failure

Intervention / Treatment
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* Procedure: NOGA XP Cardiac Navigation System
* Procedure: NOGA XP Cardiac Navigation System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group of bone marrow cell therapy<br> | Procedure: NOGA XP Cardiac Navigation System<br>* Intramyocardial multiple precision injection of bone marrow mononuclear cells<br>* Other names: Cordis Corporation's Biologics Delivery Systems;|
| Sham Comparator: group of sham therapy<br> | Procedure: NOGA XP Cardiac Navigation System<br>* Intramyocardial multiple precision injection with placebo<br>* Other names: Cordis Corporation's Biologics Delivery Systems;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in global left ventricular ejection fraction and regional wall motion score index |  | 6 and12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of the major adverse cardiac events |  | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, bone marrow mononuclear cells