Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II, Randomized, Controlled, Double-Blind Pilot Trial Evaluating the Safety and Effect of Administration of Bone Marrow Mononuclear Cells Two to Three Weeks Following Acute Myocardial Infarction
Brief Summary: More than 1 million Americans suffer heart attacks each year. Although current treatments are able to stabilize the condition of the heart, none is able to restore heart function as it was prior to the heart attack. Adult stem cells, which are immature cells that can become many different types of cells, may offer a potential means of reversing or preventing permanent damage caused by a heart attack. Recent studies have shown promise in using adult stem cells from bone marrow to reverse damage to the heart muscle caused by a heart attack, but more research is needed to assess the safety and effectiveness of stem cell use and to discover the best time to administer treatment. This study will evaluate the safety and effectiveness of using adult stem cell infusions 2 to 3 weeks after a heart attack for improving heart function in people who have had a recent heart attack and a common procedure called a percutaneous coronary intervention (PCI).


Options:
A: Inclusion criteria

1. Patients at least 21 years of age.
2. Patients with first acute MI and subsequent successful primary percutaneous coronary intervention (PCI) in an artery at least 2.5 mm in diameter occurring two to three weeks before recruitment.
3. No contraindications to undergoing cell therapy procedure within two to three weeks following AMI and PCI.
4. Hemodynamic stability as defined as no requirement for IABP, inotropic or blood pressure supporting medications.
5. Ejection fraction following reperfusion with PCI \<=45% as assessed by echocardiography.
6. Consent to protocol and agree to comply with all follow-up visits and studies.
7. Women of child bearing potential willing to use an active form of birth control.

Exclusion criteria

Patients will be excluded from the study if they meet any of the following conditions:

1. History of sustained ventricular arrhythmias not related to their AMI (evidenced by previous holter monitoring and/or medication history for sustained ventricular arrhythmias in patient's medical chart).
2. Require CABG or PCI due to the presence of residual coronary stenosis \>70% luminal obstruction in the non-infarct related vessel (Additional PCI of non-culprit vessels may be performed prior to enrollment).
3. History of any malignancy within the past five years excluding non-melanoma skin cancer or cervical cancer in-situ.
4. History of chronic anemia (hemoglobin (Hb) \<9.0 mg/dl).
5. History of thrombocytosis (platelets \>500k).
6. History of thrombocytopenia in the absence of recent evidence that platelet counts are normal
7. Known history of elevated INR (PT) or PTT.
8. Life expectancy less than one year.
9. History of untreated alcohol or drug abuse.
10. Currently enrolled in another Investigational drug or device trial
11. Previous CABG.
12. Previous MI resulting in LV dysfunction (LVEF \<55%)
13. History of stroke or transient ischemic attack (TIA) within the past six months.
14. History of severe valvular heart disease (aortic valve area \<1.0 cm2 or \>3+ mitral regurgitation).
15. Pregnancy or breast feeding
16. Subjects with a known history of HIV, or has active hepatitis B, active hepatitis C, or active tuberculosis (TB)
17. Patients with active inflammatory or autoimmune disease on chronic immunosuppressive therapy.
18. Contraindications to cMRI.
19. Previous radiation to the pelvis with white blood cell count (WBC) and platelet counts below hospital specific normal values.
20. Women child bearing potential not willing to practice an active form of birth control.
21. Chronic liver disease that might interfere with survival or treatment with cell therapy.
22. Chronic renal insufficiency as defined by a creatinine ≥2.0 mg/dL or requires chronic dialysis.
B: Inclusion Criteria:

* Men or women between 18-75 years.
* Acute myocardial infarction
* Absence of viability in the infarcted zone and LVEF \<45%.

Exclusion Criteria:

* History of prior myocardial infarction
* Significant stenosis in another coronary territory than the acutely treated vessel
C: Inclusion Criteria:

* aged 18-70 years
* ischemic chest pain for \>30 min
* admitted to hospital \<24 h after the onset of chest pain
* electrocardiography showed ST segment elevation \>1 mm in two consecutive leads in the limb leads or \>2 mm in the precordial leads
* they could be enrolled in the study \<72 h after successful revascularization

Exclusion Criteria:

* cardiogenic shock (defined as systolic blood pressure \<90 mmHg requiring intravenous pressors or intra-aortic balloon counterpulsation)
* life-threatening arrhythmia
* impossible conditions for cardiac catheterization
* advanced renal or hepatic dysfunction
* history of previous coronary artery bypass graft
* history of hematologic disease
* history of malignancy
* major bleeding requiring blood transfusion
* stroke or transient ischemic attack in the previous 6 months
* structural abnormalities of the central nervous system (brain tumor, aneurysm, history of surgery)
* traumatic injury after myocardial infarction
* use of corticosteroids or antibiotics during the previous month
* major surgical procedure in the previous 3 months
* cardiopulmonary resuscitation for \>10 min within the previous 2 weeks
* positive skin test for penicillin
* positive result for viral markers (human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and Venereal Disease Research Laboratory (VDRL) test)
* pregnancy, possible candidate for pregnancy or breastfeeding females
* drug abusers
* inappropriate patients to participate in the study according to the chief investigator
D: Inclusion Criteria:

* Acute ST-elevation myocardial infarction treated with thrombolytic therapy

Exclusion Criteria:

* Indication for rescue PCI, severe clinical heart failure, age \<18 years

Answer: A