Safety and Efficacy of Adipose Derived Stem Cells for Non-Ischemic Congestive Heart Failure

Study Overview
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Brief Summary
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The intent of this clinical study is to answer the questions: Is the proposed treatment safe Is treatment effective in improving the disease pathology of patients with Heart Disease as assessed by a series of measurements indicating improvement, stability, or degradation of a patient's cardiovascular function and exercise capacity?

Detailed Description
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This will be an open-label, non-randomized, multi-center patient-sponsored study designed to assess the safety and cardiovascular effects of Adipose-derived Stem Cell (ASC) implantation using a catheter delivery system in patients who have nonischemic congestive heart failure. A percutaneous transluminal endomyocardial injection catheter will be used for delivery of ASCs. The therapy is composed of cells isolated from a patient's own adipose tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.

Official Title
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An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Cardiovascular Effects of Intramyocardial and Intravenous Implantation of Autologous Adipose-Derived Stem Cells in Non-Ischemic Congestive Heart Failure Patients

Conditions
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Non-Ischemic Congestive Heart Failure

Intervention / Treatment
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* Procedure: Harvesting and Implantation of Adipose-Derived Stem Cells (ASCs)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to sign informed consent Age >18 years and < 80 years NYHA Class II-IV Congestive Heart Failure without an acute coronary syndrome during the prior 6 months LVEF less than or equal to 40% measured by echocardiography at both local and investigative sites, AND Left ventricular wall without mural thrombus and of thickness greater than 0.5 cm No significant valvular disease including: Moderate-to-severe mitral regurgitation (3-4+), aorticstenosis (valve area <1.5 cm2), aortic insufficiency (3-4+) Up to date on all age and gender appropriate cancer screening per American Cancer Society Exclusion Criteria: Limiting symptoms due to non-CHF causes, such as lung disease, peripheral vascular disease, arthritis or other musculoskeletal disorders Inability to complete a 6-minute walk test for any reason Need for intravenous CHF medications, chronic continuous oxygen therapy or oral steroids, Coronary Artery Bypass Surgery (CABG) surgery within 60 days prior to screening Planned revascularization within 4 months following enrollment Aortic aneurysm or dilatation (>3.8 cm by echocardiography or other imaging modality) Peripheral vascular disease at or below the distal aorta that may interfere with catheter use Hemodynamically significant pericardial disease Prior aortic or mitral valve replacement Biventricular pacing device implant within the last 3 months OR whose device is scheduled to be revised following enrollment in this trial Scheduled to receive or history of cardiac transplant, surgical remodeling procedure, left ventricular assist device Stroke within 180 days of screening Positive pregnancy test in women of child bearing potential or who are unwilling to use an acceptable method of contraception. Drug or alcohol dependence Life expectancy of less than 1 year History of cancer (other than non-melanoma skin cancer or in situ cervical cancer) in the last five years Exposure to angiogenic therapy (including myocardial laser) or another investigational drug within 60 days of screening, or enrollment in any concurrent study that may confound the results of this study Any factors in the opinion of the Investigator which render the patient unsuitable for participation, that will interfere with conduct of the study or interpretation of the results.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Harvesting and Implantation of Adipose-Derived Stem Cells (ASCs)|Local liposuction procedure to harvest the fat tissue. Adipose Derived Stem Cells are then implanted via intramyocardial and intravenous injection.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in 6 minute walk test | compared to baseline | 3 months | 
| Minnesota Living with Heart Failure Quality of Life Questionnaire |  | 3 months | 
| Improvement in 6 minute walk test |  | 6 months | 
| Minnesota Living with Heart Failure Quality of Life Questionnaire |  | 6 months | 
| Number of Adverse Events |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in New York Heart Association (NYHA) classification |  | 3 months | 
| Improvement in the Left Ventricular Ejection Fraction (LVEF) | Determined by and echo | 3 months | 
| Improvement in the Left Ventricular (LV) Volume | Determined by an echo | 3 months | 
| Improvement in New York Heart Association (NYHA) classification |  | 6 months | 
| Improvement in the Left Ventricular Ejection Fraction (LVEF) |  | 6 months | 
| Improvement in the Left Ventricular (LV) Volume |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CHF, Heart Failure, Non-Ischemic, nonischemic, nonischemia