Expired Study
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Chicago, Illinois 60611


Purpose:

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.


Criteria:

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).


NCT ID:

NCT00620048


Primary Contact:

Principal Investigator
Douglas W. Losordo, M.D.
Northwestern University


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60611
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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