Cardiac REgistry of Celution Device for the Processing of Adipose-derived Regenerative Cells

Study Overview
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Brief Summary
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This cardiac registry study will collect information from patients with ischemic or non-ischemic heart failure that have been treated with adipose-derived regenerative cells (ADRCs) delivered via intramyocardial injection.

Official Title
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Cardiac REgistry of Celution Device for the Processing of Adipose-derived Regenerative Cells: Treatment and Evaluation (CREATE)

Conditions
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Heart Failure, Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females > 20 and < 80 years of age Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization OR idiopathic dilated cardiomyopathy Symptoms of heart failure (e.g. NYHA Stages of Heart Failure Class II or III) On maximal medical therapy for heart failure and if present, anginal symptoms Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110 beats/min) Ejection fraction ≤ 45% Left ventricular wall thickness > 5 mm at the target site(s) for cell injection, confirmed by Contrast Echo within 4 weeks prior to enrollment, and free of thrombus Exclusion Criteria: Vascular anatomy and/or peripheral artery disease that prevents or impedes cardiac catheterization Aortic or mitral valve disease where valve replacement is indicated Presence of mechanical aortic or mitral valves Presence of aortic dissection Planned staged treatment of CAD or other therapeutic intervention on the heart within the subsequent 3 months TIA or stroke within 30 days prior to the procedure ICD placement or ablation therapy within 30 days prior to the procedure Acute coronary syndrome (ACS) or a myocardial infarction in the 30 days prior to the procedure Revascularization within 30 days prior to intramyocardial injection of ADRCs Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at screening or baseline.

Ages Eligible for Study
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Minimum Age: 20 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Minnesota Living with Heart Failure Questionnaire. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure Symptoms | Heart Failure Symptoms as assessed by New York Heart Association (NYHA) Functional Classification | Days 90, 180 and 360 | 
| LVESV/LVEDV | Left ventricular function assessed by contrast Echocardiography | Day 180 | 
| LVEF assessed by contrast Echocardiography | Left ventricular function assessed by contrast Echocardiography | Day 180 | 
| Treadmill exercise test |  | Day 180 | 
| Angina Symptoms | Angina Symptoms as measured by Canadian Cardiovascular Society Grading System for exertion-induced angina | Days 90, 180 and 360 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celution, ADRC, Heart Failure, Device