Cardiovascular Disease, Congestive Heart Failure, Myocardial Ischemia
Conditions
Keywords
heart, stem Cells, low EF, heart attack, cardiomyopathy, congestive heart failure, cardiovascular disease, Heart Failure, Low Ejection Fraction
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 improve your ejection fraction and heart failure symptoms.
Interventions
BIOLOGICALIntramyocardial injection of autologous CD34-positive cells (stem cells)
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.
Sponsors
Losordo, Douglas, M.D.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of intramyocardial administration of CD34-positive cells | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of intramyocardial injections of autologous CD34-positive cells on clinical outcomes. | 6 months | Clinical outcomes assessed include symptoms, change in health status, myocardial function and exercise duration. |
Countries
United States
Outcome results
None listed