Stem Cell Study for Subjects With Congestive Heart Failure

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).