Stem Cell Study for Subjects With Congestive 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: Intramyocardial injection of autologous CD34-positive cells (stem cells)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects 21 to 80 years old (inclusive). Subjects with functional class (NYHA) II or 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 (ACE)inhibitors without control of symptoms. Subjects must be identified as non-candidates for conventional revascularization by their referring cardiologist. Subjects must have left ventricular ejection fraction <40% by echocardiography. All subjects must have a recent coronary angiogram (within the last 6 months) 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 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
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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose of autologous CD34-positive cells (stem cells)<br> | Biological: Intramyocardial injection of autologous CD34-positive cells (stem cells)<br>* Comparison between a low dose and high dose of autologous (one's own) CD34-positive cells (stem cells) delivered via injections into the heart muscle.<br>|
| Experimental: High dose of autologous CD34-positive cells (stem cells)<br> | Biological: Intramyocardial injection of autologous CD34-positive cells (stem cells)<br>* Comparison between a low dose and high dose of autologous (one's own) CD34-positive cells (stem cells) delivered via injections into the heart muscle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of intramyocardial administration of CD34-positive cells |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of intramyocardial injections of autologous CD34-positive cells on clinical outcomes. | Clinical outcomes assessed include symptoms, change in health status, myocardial function and exercise duration. | 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