Stem Cell Study for Patients With Heart Failure

Phase 2

Withdrawn

• Conditions: Myocardial Ischemia; Congestive Heart Failure; Cardiovascular Disease
• Interventions: Biological: Autologous Stem Cells

• Registration Number: NCT00346177
• 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: 2006-06-27
• Study First Submitted QC: 2006-06-27
• Study First Posted: 2006-06-29
• Status Verified: 2010-09
• Study Start: 2010-09
• Last Update Submitted: 2010-09-10
• Last Update Posted: 2010-09-14
• Primary Completion: 2011-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Autologous Stem Cells	Stem Cells
2	Autologous Stem Cells	Placebo

Primary Outcome Measures

Name	Time	Method
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.	6 months

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States