Safety and Efficacy of Adipose Derived Stem Cells for Congestive Heart Failure
Safety and Efficacy of Adipose Derived Stem Cells for Congestive Heart Failure
The intent of this clinical study is to answer the questions:

 1. Is the proposed treatment safe

 2. 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?
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.
Inclusion Criteria:

 1. Willing and able to sign informed consent

 2. Age >18 years and < 80 years

 3. New York Heart Association (NYHA) Class II-IV

 4. Ischemic cardiomyopathy without an acute coronary syndrome during the prior 6 months

 5. 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+)

 6. Up to date on all age and gender appropriate cancer screening per American Cancer
 Society

 Exclusion Criteria:

 1. Limiting symptoms due to non-CHF causes, such as lung disease, peripheral vascular
 disease, arthritis or other musculoskeletal disorders

 2. Inability to complete a 6-minute walk test for any reason

 3. Need for intravenous CHF medications, chronic continuous oxygen therapyor oral
 steroids,

 4. Coronary Artery Bypass Graft (CABG) surgery within 60 days prior to screening

 5. Planned revascularization within 4 months following enrollment

 6. Aortic aneurysm or dilatation (>3.8 cm by echocardiography or other imaging modality)

 7. Peripheral vascular disease at or below the distal aorta that may interfere with
 catheter use

 8. Hemodynamically significant pericardial disease

 9. Prior aortic or mitral valve replacement

 10. Biventricular pacing device implant within the last 3 months OR whose device is
 scheduled to be revised following enrollment in this trial

 11. Scheduled to receive or history of cardiac transplant, surgical remodeling procedure,
 left ventricular assist device

 12. Stroke within 180 days of screening

 13. Positive pregnancy test in women of child bearing potential or who are unwilling to
 use an acceptable method of contraception.

 14. Drug or alcohol dependence

 15. Life expectancy of less than 1 year

 16. History of cancer (other than non-melanoma skin cancer or in situ cervical cancer) in
 the last five years

 17. 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

 18. 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.