Please select the eligibility criteria that correspond to the clinical trial below.
Title: LVAD Therapy: Exploring the Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function
Brief Summary: The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. MPCs are normally present in human bone marrow, and have been shown to increase the development of blood vessels and new heart muscle cells in the heart. In addition, this research is being done to test whether injecting the MPCs into the heart is effective in improving heart function.


Options:
A: Inclusion Criteria:

* Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation;
* Age 18 years or older;
* If the subject or partner is of childbearing potential, he or she must be willing to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening and for a period of at least 16 weeks after procedure;
* Female subjects of childbearing potential must have a negative serum pregnancy test at screening;
* Admitted to the clinical center at the time of randomization;
* Clinical indication and accepted candidate for implantation of an FDA approved implantable, non-pulsatile LVAD as a bridge to transplantation or for destination therapy.

Exclusion Criteria:

* Planned percutaneous LVAD implantation;
* Anticipated requirement for biventricular mechanical support;
* Cardiothoracic surgery within 30 days prior to randomization;
* Myocardial infarction within 30 days prior to randomization;
* Prior cardiac transplantation, LV reduction surgery, or cardiomyoplasty;
* Acute reversible cause of heart failure (e.g. myocarditis, profound hypothyroidism);
* Stroke within 30 days prior to randomization;
* Platelet count \< 100,000/ul within 24 hours prior to randomization;
* Active systemic infection within 48 hours prior to randomization;
* Presence of \>10% anti-human leukocyte antigen (anti-HLA) antibody titers with known specificity to the MPC donor HLA antigens;
* A known hypersensitivity to dimethyl sulfoxide (DMSO), murine, and/or bovine products;
* History of cancer prior to screening (excluding basal cell carcinoma);
* Acute or chronic infectious disease, including but not limited to human immunodeficiency virus (HIV);
* Received investigational intervention within 30 days prior to randomization;
* Treatment and/or an incompleted follow-up treatment of any investigational cell based therapy within 6 months prior to randomization;
* Active participation in other research therapy for cardiovascular repair/regeneration;
* Prior recipient of stem precursor cell therapy for cardiac repair;
* Pregnant or breastfeeding at time of randomization.
B: Inclusion Criteria:

* Subjects with functional class (CCS) III or IV angina.
* Subjects who have attempted "best" medical therapy without control of symptoms.
* All subjects must have a recent coronary angiogram (within the last 3 months).
* Clinical signs and symptoms of clinically significant ischemia on nuclear perfusion imaging.
* Subjects must be able to complete a minimum of 1 minute but no more than 6 minutes of the Standard Bruce Protocol.
* Subject experiences angina during the baseline exercise tolerance test.
* Subjects must either be no longer capable of reproduction or taking acceptable measures to prevent reproduction during the study.
* Normal renal function.
* Normal liver function.
* Normal blood count.

Angiographic Inclusions:

* Total occlusion of an epicardial coronary artery.
* Candidates at high risk for percutaneous coronary angioplasty of treatment zone(s) based upon clinical or anatomic considerations including but not limited to the following: diabetes, congestive heart failure (severe right heart failure, NYHA class III or IV), left main disease, pulmonary hypertension, severe proximal vessel tortuosity, severe bendpoint obstructions, diffuse disease (\>2 cm in length), small vessel (\<2 mm reference diameter), stenosis which are either diffuse (\>2 cm in length) or distal, incessant restenosis lesions, unfavorable bifurcation stenosis, and degenerated or thrombosed saphenous vein grafts.

Exclusion Criteria:

* Predominant congestive heart failure symptoms.
* Patients who have been hospitalized with a primary diagnosis of CHF in the prior 6 months.
* Patients who have had diuretics added to their medical regimen or an increase in diuretic dosage for signs or symptoms of CHF in the past 6 months.
* Patients with a left ventricular ejection fraction of less than 25% as determined by transthoracic echocardiography.
* Patients with physical findings consistent with ongoing uncontrolled CHF.
* Myocardial infarction within 30 days of treatment.
* Successful coronary revascularization procedures within 3 months of study enrollment.
* Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.
* History of severe aortic stenosis or insufficiency; severe mitral stenosis; or severe mitral insufficiency.
* Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
* Subjects with PT, PTT or platelet counts greater than the upper limit of normal and those with a hematocrit \<35%.
* Subjects with uncontrolled hypertension.
* Currently enrolled in another investigational device or drug trial (IDE or IND) that has not completed the required follow-up period.
* History of alcohol or drug abuse within 3 months of screening.
* Joint or peripheral vascular disease that severely limits treadmill walking.
* Chronic obstructive pulmonary disease that severely limits walking or FEV1.0\<30% predicted.
* Subjects who are pregnant or lactating.
* Males and females who are capable of reproduction and will not take acceptable measures to prevent reproduction during the study.
* Subjects who test positive for HIV, hepatitis B or hepatitis C, have a chronic inflammatory disease, autoimmune disease or are on chronic immunosuppressive medications.
* Subjects with a known hypersensitivity to E. coli-derived proteins.
* Subjects with evidence (clinical, laboratory, or imaging) of cancer recurrence within the past 5 years (other than non-melanoma skin cancer or in situ cervical carcinoma).
C: Inclusion Criteria:

* Established dg. of dilated CMP (defined according to ESC position statement - absence of any stenotic lesions on coronary angiography, no congenital heart disease, no primary valve disease on echocardiography, and no history of hypertension or alcohol abuse1)
* left ventricular ejection fraction \< 30%
* NYHA functional class III or IV for at least 3 months before referral
* Optimal medical management for at least 6 months

Exclusion Criteria:

* Left ventricular aneurysm or thrombus
* Hematologic disease
* Multiorgan failure
* Active malignancy
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