Clinical trial NCT00346177: Stem Cell Study for Patients With Heart Failure
Official title: Injection of Autologous CD34+ Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia and LVEF < 40%
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Myocardial Ischemia
Congestive Heart Failure
Cardiovascular Disease
Keywords: heart
stem Cells
low EF
heart attack
cardiomyopathy
congestive heart failure
cardiovascular disease
Heart Failure
Low Ejection Fraction
Lead sponsor: Losordo, Douglas, M.D.
Sponsor class: INDIV
First posted: 2006-06-29
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Subjects greater than 21 years old.
* Subjects with functional class (NYHA) 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 inhibitors without control of symptoms.
* Subjects must be identified as non-candidates for conventional revascularization by their referring cardiologist. The patient's angiogram will then be reviewed by an independent interventional cardiologist and independent cardiac surgeon to determine if the patient is eligible for revascularization.
* Subjects must have left ventricular ejection fraction \<40% by echocardiography.
* All subjects must have a recent coronary angiogram (within the last 1 year) 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 I, II or 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).

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Douglas W. Losordo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: