Stem Cell Study for Patients With Heart Failure

Last updated: September 10, 2010
Sponsor: Losordo, Douglas, M.D.
Overall Status: Trial Not Available

Phase

2

Condition

Heart Failure

Diabetes Prevention

Cardiac Disease

Treatment

N/A

Clinical Study ID

NCT00346177
BB-IND-11196-02
  • Ages > 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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-actingnitrates, maximal use of beta-adrenergic blocking agents, and angiotensin-convertingenzyme inhibitors without control of symptoms.

  • Subjects must be identified as non-candidates for conventional revascularization bytheir referring cardiologist. The patient's angiogram will then be reviewed by anindependent interventional cardiologist and independent cardiac surgeon to determineif 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) todocument the coronary anatomy and insure the presence of coronary disease that is notamenable to standard revascularization procedures.

  • Have serum B-type Natriuretic Peptide (BNP) level >100 pg/ml.

Exclusion

Exclusion Criteria:

  • Myocardial infarction (Q wave or non-Q wave defined as CKMB >3 times normal) within 30days of treatment.

  • Successful coronary revascularization procedures within 3 months of study enrollment.

  • Documented stroke or transient ischemic attack (TIA) within 60 days of studyenrollment.

  • NYHA Class I, II or IV heart failure and patients with idiopathic or non-ischemicheart 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 mitralinsufficiency(>2+).

  • Implantation of biventricular pacemaker within 90 days of study treatment.

  • Severe co-morbidity associated with a reduction in life expectancy of less than 1year, such as chronic medical illness (i.e. severe chronic obstructive pulmonarydisease, renal failure or cancer).

Study Design

Total Participants: 30
Study Start date:
September 01, 2010
Estimated Completion Date:
September 30, 2012

Connect with a study center

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

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