Injection of Autologous CD34+ Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia and LVEF < 40%

Losordo, Douglas, M.D.1 site in 1 country4 target enrollmentMarch 2008

ConditionsMyocardial Ischemia Congestive Heart Failure Cardiovascular Disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Myocardial Ischemia
Sponsor: Losordo, Douglas, M.D.
Enrollment: 4
Locations: 1
Primary Endpoint: Safety of intramyocardial administration of CD34-positive cells
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

January 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Losordo, Douglas, M.D.

Responsible Party

Sponsor

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).