Please select the eligibility criteria that correspond to the clinical trial below.
Title: Combined CABG and Stem-Cell Transplantation for Heart Failure
Brief Summary: This is a prospective double blind trial of intraoperative transmyocardial bone marrow-derived mesenchymal cell transplantation vs placebo in patients with low left ventricular ejection fraction scheduled to coronary bypass operation.


Options:
A: Inclusion Criteria:

* General (patients must have all)

  * Symptomatic heart failure.
  * Scheduled to CABG
  * Be 18 to 75 years of age
  * Informed Consent obtained
* Heart Failure Presentation

  * Patients of either gender, who has evaluated in cardiovascular laboratory and scheduled to CABG with moderate heart failure, will be eligible
  * NYHA II-IV symptoms
  * Left ventricular ejection fraction in screening echocardiography 15 to 45%.
  * Optimal heart failure medication and coronary medication before operation, containing at least two heart failure drugs: must have ACE-inhibitor, or AT II blocker, and/or b-blocker together with diuretics, digitalis or aldosterone antagonist, and coronary medication: a statin and anticoagulation, either aspirin or clopidogrel.

Exclusion Criteria:

* Heart failure due to left ventricular outflow track obstruction (valve problem or HOCM)
* History of life-threatening ventricular arrhythmias or resuscitation, condition which may be repeatable or implanted ICD.
* Stroke or other disabling condition with in 3 months before screening
* Contraindications to coronary angiogram or MRI
* Other serious disease limiting life expectancy
* Participation in an other clinical trial
* Severe valve disease: mitral, aortic, tricuspid or pulmonic stenosis / insufficiency
* Scheduled valve operation
B: 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
C: Inclusion Criteria:

* Patients aged 18 to 80
* Patients post-myocardial infarction (\> 3 months old) or with diffuse ischemic CHD
* Signed informed consent

Exclusion Criteria:

- Existing neoplastic disease or signs of tumor recurrence within the last 5 years

* Active infection
* Active internal bleeding
* Stroke within the past 2 years
* Surgery or trauma within the past two months
* Uncontrolled hypertension over 160/100
* Arteriovenous malformations or aneurysms
* HIV infection
* Signs of significant kidney or liver failure (creatinine \> 2.0 mg/dL, GOT \> 2 x upper standard value)
* Thrombopenia (\< 100,000)
* Anemia (hemoglobin \< 8.5 g/dL)
* Mental retardation
* Participation in another clinical study
* Women of childbearing age
* Chronic inflammatory disease
D: Inclusion Criteria:

* Canadian Cardiovascular Society (CCS) functional class III or IV chronic refractory angina
* subjects without control of their angina symptoms, in spite of maximal tolerated doses of anti-anginal drugs, must be on optimal therapy for their angina and on a stable anti-anginal medication regimen for at least 1 month prior to entering the screening period of the study
* identified as unsuitable for conventional revascularization
* recent coronary angiogram (within the last 12 months) to document the coronary anatomy and to verify the revascularization procedures
* subjects must have objective evidence of inducible ischemia or viable myocardium in the potential target injection zone
* a left ventricular ejection fraction equal to or greater than 25% by ECHO or single photon emission computed tomography (SPECT) at screening
* subjects must experience at minimum an average of 7 angina or anginal equivalent episodes per week
* subjects must be able to complete a minimum of 3 minutes but nor more than 10 minutes on a treadmill following the Modified Bruce Protocol
* subjects must experience angina or anginal equivalent episodes during the screening exercise treadmill test
* female subjects must either be no longer capable of reproduction or using medically valid contraception to prevent pregnancy during the study
* subjects must be willing and able to comply with specified follow-up evaluations

Exclusion Criteria:

* predominant congestive heart failure
* myocardial infarction within 60 days of treatment
* successful or partially successful coronary revascularization procedures (any vessel) within 6 months of study enrollment
* placement of a bi-ventricular pacemaker for cardiac resynchronization therapy (CRT) for heart failure in the past 90 days
* documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment
* history of moderate to severe aortic stenosis or severe aortic insufficiency; severe mitral stenosis or severe mitral insufficiency
* prosthetic aortic valve replacement
* evidence of any life-threatening arrhythmia that requires intervention on the 24-hour Holter monitor. Life-threatening arrhythmia that is successfully treated with an implantable cardioverter defibrillator (ICD) is not exclusionary.
* splenomegaly and/or severe co-morbidity associated with a reduction in life expectancy of less than 1 year, such as chronic medical illness (ie, severe chronic obstructive pulmonary disease, renal failure or cancer \[exceptions: in-situ skin cancer or fully removed skin cancer other than melanoma, in-situ cervical cancer, or cancer free for 5 years with no history of a stem cell transplant\])
* sickle cell disease or sickle cell trait
* platelet count greater than 10% above the upper limit of normal or a platelet count below 100,000 if on Clopidogrel or 50,000 without Clopidogrel
* hematocrit \<30%
* serum creatinine \>2.5 mg/dL
* any clinically significant laboratory abnormality on screening laboratories
* currently enrolled in another IDE or IND that has not completed the protocol required primary follow-up period (excludes 15 year follow up of gene therapy trials)
* history of alcohol or drug abuse within 3 months of screening
* joint or peripheral vascular disease or neurologic disease that severely limits treadmill walking
* chronic obstructive pulmonary disease that severely limits walking or FEV1 \<30% predicted
* females who are pregnant or lactating
* female subjects who are capable of reproduction and will not use medically valid contraception to prevent pregnancy during the study
* subjects who test positive for HIV, hepatitis B or hepatitis C, or are on chronic immunosuppressive medications or have had a prior stem cell transplant
* subjects with a known hypersensitivity to E. coli-derived proteins, or to any component of Neupogen (Filgrastim) or G-CSF
* subjects who have a significant psychiatric disorder or mental disability that could interfere with the subject´s ability to provide informed consent and/or comply with protocol procedures

Answer: A