Safety and Efficacy of Adipose Derived Stem Cells for 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 experienced myocardial infarction. 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 Ischemic Congestive Heart Failure Patients

Conditions
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Ischemic Congestive Heart Failure

Intervention / Treatment
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* Procedure: Fat Harvesting and Implantation of Adipose Derived Stem Cells


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 New York Heart Association (NYHA) Class II-IV Ischemic cardiomyopathy without an acute coronary syndrome during the prior 6 months Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% measured by echocardiography at both local and investigative sites, AND: Well-demarcated region of LV systolic dysfunction. 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 therapyor oral steroids, Coronary Artery Bypass Graft (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: Fat Harvesting and Implantation of Adipose Derived Stem Cells|Local Liposuction will be performed to harvest the fat. The Adipose Derived Stem Cells will be implanted via intramyocardial injection and intravenously.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in 6 Minute Walk Test |  | 3 months | 
| Improvement in the Minnesota Living with Heart Failure Quality of Life Questionnaire |  | 3 months | 
| Improvement in 6 Minute Walk Test |  | 6 months | 
| Improvement in the Minnesota Living with Heart Failure Quality of Life Questionnaire |  | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CHF, ischemia, Heart Failure