Status:
TERMINATED
Stem Cell Study for Subjects With Congestive Heart Failure
Lead Sponsor:
Losordo, Douglas, M.D.
Conditions:
Myocardial Ischemia
Congestive Heart Failure
Eligibility:
All Genders
21-80 years
Phase:
PHASE1
Brief Summary
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 impr...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00620048
Start Date
March 1 2008
Last Update
March 31 2015
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611