Clinically significant cardiac disease (New York [NY] Heart Association class III or IV), including chronic arrhythmia, or pulmonary disease Active angina pectoris or NY Heart Association Class III-IV Any clinically-significant cardiac disease defined as New York Heart Association class III or IV within the past 6 months of Screening, unless, in the opinion of the Investigator, the disease is well-controlled TREATMENT EXCLUSION: Symptomatic cardiac disease (New York Heart Association [NYHA] class III or IV disease) Uncontrolled coronary disease or New York Heart Association (NYHA) class III-IV heart disease The patients must not be candidates for chemotherapy due to at least one of the following reasons:\r\n* Performance status of 2\r\n* Creatinine clearance =< 60 ml/min as calculated by the Cockcroft-Gault formula\r\n* Cardiac disease such as New York Heart Association (NYHA) class III or IV heart failure or cardiac ischemia within the last 12 months, grade 2 or greater neuropathy, or other comorbidities based on which patient is not considered a candidate for chemotherapy New York Heart Association (NYHA) Class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition, or hypertensive or metabolic condition. Cardiac failure New York Heart Association (NYHA) III or IV Crohn’s disease or ulcerative colitis New York Heart Association (NYHA) class III or IV heart disease Major cardiovascular or pulmonary comorbidity that precludes use of general anesthesia (NYHA [New York Heart Association] class III and IV) Serious intercurrent chronic or acute illness, such as cardiac disease (New York Heart Association [NYHA] class III or IV), hepatic disease, or other illness considered by the principal investigator as unwarranted high risk for investigational drug treatment Significant cardiac disease (New York Heart Association classes III or IV) or unstable angina despite medication Clinically significant heart disease, defined as New York Heart Association (NYH) class III or IV Severe cardiac insufficiency (New York Heart Association [NYHA] III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease Patients with serious intercurrent chronic or acute illness, such as cardiac disease (New York Heart Association [NYHA] class III or IV), hepatic disease, or other illness considered by the principal investigator as unwarranted high risk for investigational drug treatment Significant cardiovascular abnormalities as defined by any one of the following: New York Heart Association (NYHA) class III or IV congestive heart failure, clinically significant hypotension, uncontrolled symptomatic coronary artery disease, or a documented ejection fraction of < 35% Patients with clinically significant heart disease (NYHA Class III or IV). Uncontrolled coronary disease or New York Heart Association (NYHA) class III-IV heart disease Significant cardiac disease (New York Heart Association classes III or IV) or unstable angina despite medication; Part 2: history of have severe cardiac disease (New York Heart Association functional class III or IV) Evidence of New York Heart Association (NYHA) functional class III or IV heart disease Adequate cardiac functions assessed by 2 dimensional (D) echocardiography (ECHO).\r\n* (New York Heart Association [NYHA] cardiac III-IV excluded). Clinically significant cardiac disease, including major cardiac dysfunction, such as uncontrolled angina, clinical congestive heart failure with New York Heart Association (NYHA) class III or IV, ventricular arrhythmias requiring anti-arrhythmic therapy Evidence of New York Heart Association (NYHA) functional class III or IV heart disease Clinically significant cardiac disease (New York Heart Association, class III or IV) Clinically significant cardiac disease (New York Heart Association class III/IV) or severe debilitating pulmonary disease Evidence of New York Heart Association (NYHA) functional class III or IV heart disease Subjects who have a history or current evidence of uncontrolled cardiovascular disease i.e. NYHA (New York Heart Association) Class III or IV. Normal cardiac function\r\n* No active coronary artery disease\r\n* No New York Heart Association class II, III or IV disease\r\n* No arrhythmia requiring treatment\r\n* Baseline echocardiogram with a shortening fraction of >= 27% or an ejection fraction >= 50% New York Heart Association class III or IV cardiovascular disease New York Heart Association Class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition, or hypertensive or metabolic condition No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease Evidence of New York Heart Association (NYHA) functional class III or IV heart disease Clinically significant cardiac disease (New York [NY] Heart Association class III or IV), including chronic arrhythmias, or pulmonary disease Patients with New York Heart Association class 3 or 4 disease Clinically significant cardiac disease (New York [NY] Heart Association class III or IV) or pulmonary disease New York Heart Association (NYHA) class III or IV heart disease Clinically significant cardiac disease (New York Heart Association class III/IV) or severe debilitating pulmonary disease Clinically significant cardiac disease (New York Heart Association class III/IV) or severe debilitating pulmonary disease Any clinically significant cardiac disease defined as NYHA class III or IV. DONOR: History of severe cardiovascular disease, defined as New York Heart Association class III or IV New York Heart Association (NYHA) class III or IV; NOTE: patients classified as NYHA class II controlled with treatment may participate, with increased monitoring Class III or IV cardiovascular disease according to the New York Heart Association's (NYHA) Functional Criteria. No New York Heart Association (NYHA) class III or IV heart disease Class III or IV cardiovascular disease according to the New York Heart Association's (NYHA) Functional Criteria. Normal cardiac function:\r\n* No active coronary artery disease\r\n* No New York Heart Association class II, III, or IV disease\r\n* No arrhythmia requiring treatment Clinically significant heart disease (New York Heart Association [NYHA] class III or IV) within six months Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV) Severe cardiac disease (New York Heart Association functional class III or IV) or coronary artery disease Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV) Have with history of severe cardiac disease (New York Heart Association functional class III or IV) Severe cardiac disease (New York Heart Association class III or greater) Severe cardiac insufficiency (New York Heart Association class [NYHA] III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease New York Heart Association class III/IV cardiac disease Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV) (PCS study)