Please select the eligibility criteria that correspond to the clinical trial below.
Title: C-Cure - Safety, Feasibility and Efficacy of Guided Bone Marrow-derived Mesenchymal Cardiopoietic Cells for the Treatment of Heart Failure Secondary to Ischemic Cardiomyopathy
Brief Summary: The purpose of this clinical trial is to evaluate the feasibility, safety and efficacy of left ventricular endocardial injection of guided bone marrow-derived cardiopoietic cells (C-Cure) in the setting of chronic heart failure secondary to ischemic cardiomyopathy.


Options:
A: Inclusion Criteria:

* Subject is ≥ 18 and \< 75 years old;
* Subject has Heart Failure, New York Heart Association (NYHA) class II or class III with LVEF \> 15% and ≤ 40% as assessed by transthoracic echocardiography;
* Subject has ischemic heart disease;
* Subject has an identifiable (by transthoracic echocardiography) area of transmural scar within the left ventricle;
* Subject is on optimal and stable medical therapy for more than 2 months;
* Subject is willing and able to undergo an ICD implantation, prior to receiving C-Cure™ or already has an ICD implanted;
* Subject agrees to comply with all follow-up evaluations;
* Subject has been informed of the nature of the clinical trial and agrees to its provision and has provided written informed consent.

Exclusion Criteria:

* Subject has been treated with cell-based therapy;
* Subject has myocardial revascularization by PCI or CABG within 2 months prior to enrolment;
* Subject has had an MI within 2 months prior to enrolment;
* Subject is planned for PCI, CABG or any cardiac surgery;
* Subject has received a biventricular pacemaker within 6 month prior to enrolment;
* Subject has moderate to severe aortic valve heart disease, aortic or mitral prosthetic valve;
* Subject has a significant mitral valve insufficiency (Effective Regurgitant Orifice (ERO) \> 0.2 cm²) with possibility of mitral valve surgery;
* Subject has left ventricular thrombus;
* Subject has LV aneurysma or is a candidate for surgical aneurysmectomy;
* Subject LV ventricular wall thickness is \< 5 mm in the target territory;
* Subject has proven high grade atrioventricular block or sustained ventricular tachyarrhythmias;
* Subject has an hemodynamically significant congenital heart disorder;
* Subject has clinical evidence for infection or active malignancy;
* Subject has known stable chronic kidney dysfunction with serum creatinine \> 2.5 mg/dL at two occasions during the screening period;
* Subject has experienced severe adverse reaction/allergies to contrast agents;
* Subject has atherosclerosis and/or tortuosity of the aorta, iliac or femoral arteries of a degree, that could impede or preclude the safe retrograde passage of the delivery catheter, in the judgment of the investigator;
* Subject is on chronic immunosuppressive transplant therapy;
* Subject had an autologous or allogenic bone marrow or peripheral stem cell transplant or prior solid organ transplantation;
* Subject has a multisystem disease;
* Subject has been tested positive for Human Immunodeficiency Virus (HIV 1 or HIV 2), Hepatitis B Virus (HBV), Hepatitis C (HCV) and/or syphilis;
* Women of child bearing potential;
* Subject has life expectancy \< 1 year from non heart failure related causes;
* Subject suffers from morbid obesity (Body Mass Index (BMI) \> 40);
* Subject has a recent history of alcohol or drug abuse;
* Subject has any other surgical or medical condition that, in the judgment of the investigator might warrant exclusion or be contraindicated for safety reasons;
* Subject is currently participating in another trial.
B: 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
C: Inclusion Criteria:

1. Patients with coronary disease undergoing CABG.
2. At least 3 months since last episode of myocardial infarction
3. Patients fulfilling either of the following criteria based on the extent of CAD by coronary angiography and LVEF by echocardiography.

   Reversible myocardial ischemia as revealed by SPECT. ejection fraction \>=40% \<=50%. Age \>=18 years and \<=70 Patients who can give informed consent themselves in writing.
4. Negative pregnancy test (in women with childbearing potential).

Exclusion Criteria:

Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.

1. Sustained ventricular tachycardia in a 24-hour ECG.
2. Chronic atrial fibrillation.
3. Less than 3 months since last episode of cerebral infarction.
4. Patients with a malignant tumor\*.
5. Patients with chronic rheumatoid arthritis.
6. Patients with a history of severe allergic reactions.
7. Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
8. Patients currently suffering from or having a history of interstitial pneumonitis.
9. Leukocytes less than 4,000/µL or exceeding 10,000/µL.
10. Platelets less than 100,000/µL.
11. Hemoglobin less than 10 g/dL.
12. AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
13. Patients for whom it is impossible to perform both cardiac MRI
14. Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
15. Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
D: Inclusion Criteria:

* Patients with chronic ischemic heart disease
* Patients with anterior myocardial infarction \> 3months
* EF \< 50% or NYHA II-IV
* Age 18-80
* Informed consent

Exclusion Criteria:

* Ventricular thrombus
* Infarct \< 3 months.
* Active infection or fever
* Chronic inflammatory disease (e.g M. Crohn, Rheumatoid Arthritis)
* HIV Infection oder active Hepatitis
* Neoplastic disease w/o complete remission within 5 years
* Stroke \< 3months
* Creatinine \> 2 mg/dl
* Relevant Liver disease (GOT \> twice the upper limit).
* Anemia (Hemoglobin \<10 mg/dl)
* Thrombocytopenia \< 100.000/µl
* Allergies to Aspirin, Clopidogrel, Heparin
* History of bleeding disorder
* History of coagulopathy
* Gastrointestinal Bleeding \< 3 months
* Surgery or Trauma \< 2 months
* Pregnancy
* Mental Retardation
* Participation in other clinical study \< 1 month

Answer: A