Stem Cell Study for Subjects With Congestive Heart Failure

NCT ID: NCT00620048

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31

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.

Conditions

Myocardial Ischemia; Congestive Heart Failure; Cardiovascular Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low dose of autologous CD34-positive cells (stem cells)

Group Type: EXPERIMENTAL

Intramyocardial injection of autologous CD34-positive cells (stem cells)

Intervention Type: BIOLOGICAL

Comparison between a low dose and high dose of autologous (one's own) CD34-positive cells (stem cells) delivered via injections into the heart muscle.

High dose of autologous CD34-positive cells (stem cells)

Group Type: EXPERIMENTAL

Intramyocardial injection of autologous CD34-positive cells (stem cells)

Intervention Type: BIOLOGICAL

Comparison between a low dose and high dose of autologous (one's own) CD34-positive cells (stem cells) delivered via injections into the heart muscle.

Interventions

Intramyocardial injection of autologous CD34-positive cells (stem cells)

Comparison between a low dose and high dose of autologous (one's own) CD34-positive cells (stem cells) delivered via injections into the heart muscle.

Intervention Type: BIOLOGICAL

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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Losordo, Douglas, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas W. Losordo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

11196-03

Identifier Type: OTHER

Identifier Source: secondary_id

STU00002516

Identifier Type: -

Identifier Source: org_study_id