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Stem Cell Study for Patients With Heart Failure

NCT ID: NCT00346177

Last Updated: 2010-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Myocardial Ischemia Congestive Heart Failure Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Stem Cells

Group Type ACTIVE_COMPARATOR

Autologous Stem Cells

Intervention Type BIOLOGICAL

Intramyocardial injections

2

Placebo

Group Type PLACEBO_COMPARATOR

Autologous Stem Cells

Intervention Type BIOLOGICAL

Intramyocardial injections

Interventions

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Autologous Stem Cells

Intramyocardial injections

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Losordo, Douglas, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Northwestern University/Northwestern Memorial Hospital

Principal Investigators

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Douglas W. Losordo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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BB-IND-11196-02

Identifier Type: -

Identifier Source: org_study_id