Clinical trial NCT00620048: Stem Cell Study for Subjects With Congestive 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: TERMINATED
Phase: PHASE1
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: 2008-02-21
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_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 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).

Primary outcomes:
measure: Safety of intramyocardial administration of CD34-positive cells
timeFrame: 6 months
Secondary outcomes:
measure: Effects of intramyocardial injections of autologous CD34-positive cells on clinical outcomes.
timeFrame: 6 months
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: