Effectiveness of Stem Cell Treatment for Adults With Ischemic Cardiomyopathy (The FOCUS Study)
Condition: Chronic Ischemic Heart Disease; Left Ventricular Dysfunction; Angina; Ischemic Cardiomyopathy
MeSH terms: Heart Diseases; Cardiomyopathies; Myocardial Ischemia; Coronary Artery Disease; Ventricular Dysfunction; Ventricular Dysfunction, Left; Ischemia
Intervention: Adult stem cells; Placebo
Intervention description: Single procedure of intramyocardial electromechanical-guided injection of approximately 100 million bone marrow mononucleated cells (BM-MNCs), administered in 15 different injection sites; Single procedure of intramyocardial electromechanical-guided needle insertions and injection of 5% human serum albumin and saline in 15 different injection sites
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Congestive Heart Failure; Regional Wall Motion; Perfusion Defects

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-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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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