Status:
COMPLETED
Effectiveness of Stem Cell Treatment for Adults With Ischemic Cardiomyopathy (The FOCUS Study)
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Cardiovascular Cell Therapy Research Network (CCTRN)
Conditions:
Chronic Ischemic Heart Disease
Left Ventricular Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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-spec...
Detailed Description
Coronary artery disease (CAD), a disease in which blood vessels become clogged by a build-up of plaque, is the leading cause of heart failure, a condition in which the heart can no longer pump enough ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00824005
Start Date
March 1 2009
End Date
May 1 2012
Last Update
July 1 2015
Active Locations (5)
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1
University of Florida-Department of Medicine
Gainesville, Florida, United States, 32611
2
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232