IMMNC-HF: IntraMyocardial Injection of Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients

Study Overview
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Brief Summary
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This is a prospective, randomised double blind, controlled, parallel-group phase I and II study. Its aim is to assess the Evaluation of the intramyocardial injection of autologous bone marrow derived mononuclear stem cells is safe and effective in hear failure patients with reduced left ventricular ejection fraction(<=30%) when compared to a control group of patients undergoing best medical care.

Official Title
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Evaluation of the Intramyocardial Injection of Autologous Bone Marrow Derived Mononuclear Stem Cells in Heart Failure (HF) Patients

Conditions
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Heart Failure

Intervention / Treatment
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* Biological: Intramyocardial injection of stem cell
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women of any ethnic origin 18 ≤ aged≤ 65 years EF≤40 (by Echocardiography) and regional wall motion abnormality Not responding to standard therapies the New York Heart Association (NYHA) class ≥ III Myocardial infarction due to coronary artery atherosclerotic disease An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI) Normal liver and renal function No or controlled diabetes Able to give voluntary written consent and understand the study information provided to him Exclusion Criteria: Participation in another clinical trial within 30 days prior randomisation Previously received stem/progenitor cell therapy Pregnant women Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol Cardiogenic shock requiring mechanical support Congenital / valvular heart disease Implantable cardioverter defibrillator (ICD) transplant Platelet count <100.000/µl, or hemoglobin <8.5 g/dl Impaired renal function, i.e. creatinine >2.5 mg/dl Fever or diarrhea within 4 weeks prior screening History of bleeding disorder within 3 months prior screening Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg) or Sustained ventricular arrhythmia Life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intramyocardial injection of stem cell<br>Intramyocardial injection of autologous bone marrow mononuclear cells in patients with Heart Failure | Biological: Intramyocardial injection of stem cell<br>* Autologous bone marrow-derived mononuclear cells are obtained from 100-150ml of bone marrow aspirated under local anaesthesia from the iliac crest. Intramyocardial injection of the cells is performed in patients with Heart failure in open heart surgery (CABG)<br>|
| Placebo Comparator: Placebo<br>Placebo intramyocardial injection in patients with Heart Failure | Biological: Placebo<br>* Injection of Placebo in patients with Heart failure in open heart surgery (CABG)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | The rate of patients mortality after transplantation | 12 months | 
| Hospitalization | the rate of hospitalization after transplantation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ejection fraction changes | Elevation of ejection fraction in patients after transplantation | 12 months | 
| 6-minute walk test (6MWT) | Evaluation the improvement of 6MWT test after transplantation | 12 months | 
| Pro b-type natriuretic peptide (Pro-BNP) changes | Elevation the reduction of Pro-BNP in patients after transplantation | 12 months | 
| NYHA functional class | Evaluation the improvement of NYHA functional class in patients | 12 months |