Stem Cell Study for Subjects With Congestive Heart Failure

This is an interventional treatment trial for Myocardial Ischemia focused on measuring heart, stem Cells, low EF, heart attack, cardiomyopathy, congestive heart failure, cardiovascular disease, Heart Failure, Low Ejection Fraction Read More

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).