Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase I/II, Randomized, Double-Blinded, Placebo-Controlled Study of the Safety and Efficacy of Intramyocardial Injection of Autologous Human Mesenchymal Stem Cells (MSCs) in Patients With Chronic Ischemic Left Ventricular Dysfunction Secondary to Myocardial Infarction (MI) Undergoing Cardiac Surgery for Coronary Artery Bypass Grafting (CABG)
Brief Summary: Heart attacks are a leading cause of death in both men and women in the United States. When a person has a heart attack, blood is unable to reach a certain area of the heart, and if the blood supply is not re-established quickly, that area of the heart can suffer permanent damage. While recovery from a heart attack can be managed through medications and lifestyle changes, these treatments can not reverse the original damage to the heart. Current research is focusing on the development of cell-based therapies using stem cells to repair organs that have been irreversibly damaged by disease. A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown promise for heart repair. This study will evaluate the safety and effectiveness of injecting MSCs into the heart to repair and restore heart function in people who have had a heart attack and who are having heart surgery for coronary artery bypass grafting (CABG).


Options:
A: Inclusion Criteria:

* Diagnosis of chronic ischemic heart failure caused by a heart attack
* Scheduled to undergo cardiac surgery for CABG
* Ejection fraction between 15% and 50%
* Presence of an akinetic or dyskinetic region by standard imaging

Exclusion Criteria:

* Glomerular filtration rate of less than 50 mL/min/1.73m2 at study entry
* Contraindication to performance of an MRI scan
* Bone marrow dysfunction, as evidenced by a 20% or more deviation from normal hematocrit, white blood cell count, or platelet values without another explanation
* A coagulopathy condition not due to a reversible cause (i.e., Coumadin)
* Known, serious radiographic contrast allergy
* Known allergies to penicillin or streptomycin
* Organ transplant recipient
* Clinical history of malignancy within 5 years of study entry (e.g., 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 less than 1 year
* On chronic therapy with immunosuppressant medication
* Serum positive for HIV, hepatitis B, or hepatitis C
* Female who is pregnant, nursing, or of child-bearing potential and not practicing effective birth control methods
B: Inclusion Criteria:

* Chronic cardiac ischemic disease at least 4 months after one ore more myocardial infarctions in a stable phase of the disease without option for revascularization
* LVEF at echocardiography ≤ 40%
* Significant regional LV wall motion dysfunction in the infarct related territory
* Symptoms NYHA II-IV or CCS II-III (at least class III according to one of the two classifications)
* Patient agrees to comply with all follow-up evaluations
* Age \> 18 years old
* Patient has been informed of the nature of the clinical trial and agrees to its provision and has provided written informed consent

Exclusion Criteria:

* Abnormal regional wall motion outside the infarct region
* Need for revascularization in a non infarct-related coronary within 6 months
* Patient has moderate to severe aortic valve disease, aortic or mitral prosthetic valve
* Patient has a significant mitral valve insufficiency (Effective Regurgitant office - ERO - \> 0.2 cm2 with possibility of mitral valve surgery
* Left ventricular thrombus at echocardiography
* LV-aneurysma planned surgical aneurysmectomy
* LV-wall thickness \< 5mm in the target territory
* Congenital heart disorder of hemodynamic relevance
* Known active infection or chronic infection with HIV, HBV or HCV
* Chronic inflammatory disease
* Serious concomitant disease with a life expectancy of less than one year
* Follow up impossible (no fixed abode, etc)
* Contraindication for cardiac MRI (i.e. pace maker, neurostimulator, claustrophobia)
* Severe renal failure (creatinine \> 250 mmol/l)
* Relevant liver disease (GOT \> 2x norm or spontaneous INR \> 1,5)
* Anemia (Hb \< 8.5 mg/dl), Thrombocytopenia (\< 100.000/µl)
* Women of child bearing potential or pregnancy
* Participation at a clinical trial in the last 30 days
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 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

Answer: A