Effectiveness of Stem Cell Treatment for Adults With Ischemic Cardiomyopathy (The FOCUS Study)

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Ischemic Heart Disease, Left Ventricular Dysfunction, Angina, Ischemic Cardiomyopathy

In brief

Coronary artery disease (CAD) is a common disorder that can lead to heart failure. Not all people with CAD are eligible for today's standard treatments. One new treatment approach uses stem cells-specialized cells capable of developing into other types of cells-to stimulate growth of new blood vessels for the heart. This study will determine the safety and effectiveness of withdrawing stem cells from someone's bone marrow and injecting those cells into the person's heart as a way of treating people with CAD and heart failure.

Key facts

Study ID

NCT00824005

Run by

The University of Texas Health Science Center, Houston

People needed

92

Starts

2009-03-01

Expected to finish

2012-05-01

Last updated by the study team

2015-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients >18 years of age with significant coronary heart disease not amenable to revascularization.
• Left ventricular dysfunction (LVEF) less than or equal to 45%, measured by echocardiogram; limiting angina (Class II to IV); and/or congestive heart failure (CHF), NYHA class II to III
• Receiving maximal medical therapy, defined as a medical regimen that includes the maximal tolerated dose of at least two antiangina medications, such as beta-blockers, nitrates, or calcium-channel blockers
• Presence of a defect, as identified by single photon emission computed tomography (SPECT) isotope protocol, or viability, as identified by NOGA electromechanical cardiac mapping system
• Coronary artery disease not well suited to any other type of revascularization procedure in the target region of the ventricle, as determined by a cardiovascular surgeon and interventional cardiologist who are not investigators in the trial
• Hemodynamic stability, as defined by systolic blood pressure of at least 80 mm Hg without intravenous pressors or support devices
• Females of childbearing potential must be willing to use two forms of birth control for the duration of the study

You may not qualify if…

• Atrial fibrillation or flutter without a pacemaker that guarantees a stable heart rate
• Unstable angina
• Left ventricular (LV) thrombus, as documented by echocardiography or LV angiography
• A vascular anatomy that precludes cardiac catheterization
• Severe valvular disease or mechanical aortic valve that precludes safe entry of the catheter into the left ventricle
• Pregnant or lactating
• Platelet count less than 100,000 per mm3
• White blood cell count less than 2,000 per mm3
• Revascularization within 30 days of consent
• Transient ischemic attack or stroke within 60 days of study consent
• Implantable cardioverter-defibrillator shock within 30 days of baseline consent, and within 30 days of randomization
• Presence of ventricular tachycardia lasting 30 seconds or more on 24-hour Holter monitor or electrocardiogram (ECG) performed during screening period
• Bleeding diathesis, defined as an international normalized ratio of at least 2.0 in the absence of warfarin therapy
• A history of malignancy in the last 5 years excluding basal cell carcinoma, that has been surgically removed, with proof of surgical clean margins
• Has a known history of HIV, has active hepatitis B or active hepatitis C
• Any condition requiring immunosuppressive medication
• High-risk acute coronary syndrome (ACS) or a myocardial infarction in the month prior to consent
• A left ventricular wall thickness of <8 mm (by echocardiogram) of the infero-lateral wall at the target site for cell injection.
• Inability to walk on a treadmill, except for class IV angina patients, who will be evaluated separately
• Enrolled in an investigational device or drug study within the previous 30 days
• Hepatic dysfunction, as defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 1.5 times the upper limit of normal range prior to study entry
• Chronic renal insufficiency, defined as a serum creatinine level greater than 2.5 mg/dL or requiring dialysis
• Any other condition that in the judgment of the investigator would be a contraindication to enrollment or follow-up

Where it is running

• University of Florida-Department of Medicine — Gainesville, Florida, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Texas Heart Institute — Houston, Texas, United States

Full record on ClinicalTrials.gov

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