Stem Cell Study for Patients With Heart Failure

Study Overview
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Brief Summary
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The purpose of this study is to determine if cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will improve your ejection fraction and heart failure symptoms.

Official Title
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Injection of Autologous CD34+ Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia and LVEF < 40%

Conditions
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Myocardial Ischemia, Congestive Heart Failure, Cardiovascular Disease

Intervention / Treatment
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* Biological: Autologous Stem Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects greater than 21 years old. Subjects with functional class (NYHA) III ischemic heart failure. Subjects who have attempted best cardiac medical therapy including long-acting nitrates, maximal use of beta-adrenergic blocking agents, and angiotensin-converting enzyme inhibitors without control of symptoms. Subjects must be identified as non-candidates for conventional revascularization by their referring cardiologist. The patient's angiogram will then be reviewed by an independent interventional cardiologist and independent cardiac surgeon to determine if the patient is eligible for revascularization. Subjects must have left ventricular ejection fraction <40% by echocardiography. All subjects must have a recent coronary angiogram (within the last 1 year) to document the coronary anatomy and insure the presence of coronary disease that is not amenable to standard revascularization procedures. Have serum B-type Natriuretic Peptide (BNP) level >100 pg/ml. Exclusion Criteria: Myocardial infarction (Q wave or non-Q wave defined as CKMB >3 times normal) within 30 days of treatment. Successful coronary revascularization procedures within 3 months of study enrollment. Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment. NYHA Class I, II or IV heart failure and patients with idiopathic or non-ischemic heart failure. History of severe aortic stenosis (aortic valve area < 1.0 cm2) or insufficiency (>2+); severe mitral stenosis (mitral valve area <1.5 cm2); or severe mitral insufficiency(>2+). Implantation of biventricular pacemaker within 90 days of study treatment. Severe co-morbidity associated with a reduction in life expectancy of less than 1 year, such as chronic medical illness (i.e. severe chronic obstructive pulmonary disease, renal failure or cancer).

Ages Eligible for Study
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Minimum Age: 21 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Stem Cells | Biological: Autologous Stem Cells<br>* Intramyocardial injections<br>|
| Placebo Comparator: 2<br>Placebo | Biological: Autologous Stem Cells<br>* Intramyocardial injections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The purpose of this study is to determine if cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will improve your ejection fraction and heart failure symptoms. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart, stem Cells, low EF, heart attack, cardiomyopathy, congestive heart failure, cardiovascular disease, Heart Failure, Low Ejection Fraction