Stem Cell Study for Subjects With Congestive Heart Failure

Phase 1

Terminated

• Conditions: Myocardial Ischemia; Cardiovascular Disease; Congestive Heart Failure
• Interventions: Biological: Intramyocardial injection of autologous CD34-positive cells (stem cells)

• Registration Number: NCT00620048
• Lead Sponsor: Losordo, Douglas, M.D.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-07
• Study First Submitted QC: 2008-02-07
• Study First Posted: 2008-02-21
• Study Start: 2008-03
• Primary Completion: 2011-01
• Status Verified: 2011-11
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose of autologous CD34-positive cells (stem cells)	Intramyocardial injection of autologous CD34-positive cells (stem cells)	-
Low dose of autologous CD34-positive cells (stem cells)	Intramyocardial injection of autologous CD34-positive cells (stem cells)	-

Primary Outcome Measures

Name	Time	Method
Safety of intramyocardial administration of CD34-positive cells	6 months

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States