Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized, Controlled, Phase II, Double-Blind Trial of Intramyocardial Injection of Autologous Bone Marrow Mononuclear Cells Under Electromechanical Guidance for Patients With Chronic Ischemic Heart Disease and Left Ventricular Dysfunction
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-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.


Options:
A: 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
B: Inclusion Criteria:

* Coronary artery disease with indication for CABG surgery
* Reduced global left ventricular ejection fraction by transthoracic echocardiography at rest (EF ≤ 35%)
* Presence of a localized akinetic/hypokinetic/hypoperfused area of LV myocardium for defining the target area
* Informed consent of the patient
* Age \> 18 years

Exclusion Criteria:

* Emergency operation
* Presence of aortic valve disease requiring concomitant valve replacement
* Debilitating other disease: Degenerative neurologic disorders, psychiatric disease, terminal renal failure requiring dialysis, previous organ transplantation, active malignant neoplasia
* History of ventricular arrhythmia (≥ Lown III)
* Impaired ability to comprehend the study information
* Absent informed written consent
* Apparent infection (CRP ≥ 20 mg/L, fever (≥38.5° C)
* Acute myocardial infarction
* contraindication for MRI assessment
* Pregnancy or lactation
C: Inclusion Criteria:

* Diagnosis of chronic ischemic left ventricular dysfunction secondary to MI.
* Be a candidate for cardiac catheterization.
* Been treated with appropriate maximal medical therapy for heart failure or post-infarction left ventricular dysfunction.
* Ejection fraction less than or equal to 50%.
* Able to perform a metabolic stress test.

Exclusion Criteria:

* Baseline glomerular filtration rate \< 45 ml/min/1.73m2.
* Presence of a mechanical aortic valve or heart constrictive device.
* Documented presence of aortic stenosis (aortic stenosis graded as ≥+2 equivalent to an orifice area of 1.5cm2 or less).
* Documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥+2).
* Evidence of a life-threatening arrhythmia (nonsustained ventricular tachycardia ≥ 20 consecutive beats or complete heart block) or QTc interval \> 550 ms on screening ECG. In addition; patients with sustained or a short run of ventricular tachycardia on ECG or 48 hour Ambulatory ECG during the screening period will be removed from the protocol.
* Documented unstable angina.
* AICD firing in the past 60 days prior to the procedure.
* Contra-indication to performance of a magnetic resonance imaging scan.
* Be eligible for or require coronary artery revascularization.
* Have a hematologic abnormality as evidenced by hematocrit \< 25%, white blood cell \< 2,500/ul or platelet values \< 100,000/ul without another explanation.
* Have liver dysfunction, as evidenced by enzymes (ALT and AST) greater than three times the ULN.
* Have a coagulopathy condition = (INR \> 1.3) not due to a reversible cause.
* Known, serious radiographic contrast allergy.
* Known allergies to penicillin or streptomycin.
* Organ transplant recipient.
* Clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
* Non-cardiac condition that limits lifespan to \< 1 year.
* On chronic therapy with immunosuppressant medication.
* Serum positive for HIV, hepatitis BsAg, or non-viremic hepatitis C.
* Female patient who is pregnant, nursing, or of child-bearing potential and not using effective birth control.
D: Inclusion Criteria:

* Coronary artery disease after myocardial infarction with indication for CABG surgery
* Currently reduced global LVEF assessed at site by cardiac MRI at rest (25% ≤ LVEF ≤ 50%)
* Presence of a localized akinetic/hypokinetic/hypoperfused area of LV myocardium for defining the target area
* Informed consent of the patient
* 18 years ≤ Age \< 80 years
* Are not pregnant and do not plan to become pregnant during the study. Females with childbearing potential must provide a negative pregnancy test within 1-7 days before OP and must be using oral or injectable contraception (non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before study start).

Exclusion Criteria:

* Emergency operation
* Presence of any moderate-severe valvular heart disease requiring concomitant valve replacement or reconstruction
* Medical History of recent resuscitation in combination with ventricular arrhythmia classified by LOWN ≥ class II
* Acute myocardial infarction within last 2 weeks
* Debilitating other disease: Degenerative neurologic disorders, psychiatric disease, terminal renal failure requiring dialysis, previous organ transplantation, active malignant neoplasia, or any other serious medical condition that, in the opinion of the Investigator is likely to alter the patient's course of recovery or the evaluation of the study medication's safety
* Impaired ability to comprehend the study information
* Absent informed written consent
* Treatment with any investigational drug within the previous 30 days
* Apparent infection (c-reactive protein \[CRP\] ≥ 20 mg/L, fever ≥ 38.5° C)
* Contraindication for MRI scan
* Immune compromise including active infection with Hepatitis B, C, HIV virus or seropositivity for Treponema pallidum
* Pregnant or breast feeding
* Childbearing potential with unreliable birth control methods
* Have previously been enrolled in this study, respectively phase I and phase II
* Known hypersensitivity or sensitization against murine products and human-anti-mouse-antibody-titer ≥ 1:1000
* Contraindication to bone marrow aspiration
* Known hypersensitivity against iron dextran

Answer: A