Please select the eligibility criteria that correspond to the clinical trial below.
Title: AMORCYTE MYOCARDIAL REPAIR STUDY- A Phase I Trial of Intra-coronary Infusion of Bone Marrow Derived Autologous CD34+ Selected Cells in Patients With Acute Myocardial Infarction. (AMRS)
Brief Summary: Following a Heart attack the acute loss of heart muscle cells results in a cascade of events causing an immediate decrease in cardiac function that has the potential to persist long term. Despite revascularization of the infarct related artery circulation and appropriate medical management to minimize the stresses on the heart walls, a significant percentage of patients experience permanent cardiac dysfunction and consequently remain at an increased life-time risk of experiencing adverse cardiac events, including death.

There is a great potential for stem cell therapy, using a variety of cell precursors (particularly hematopoietic,)to contribute to new blood vessel formation (and possibly limited heart muscle formation) and muscle preservation in the myocardial infarct zone. The administration of cells via an infusion through the infarct related artery appears to be feasible and result in a clinical effect in some studies.

Therefore, we propose to evaluate the safety and efficacy of a CD34+ selected stem cell product (AMR-001), administered through the infarct related coronary artery 6 to 9 days after successful infarct related artery stent placement.

The primary objective of the study is to determine the feasibility and safety of prospectively identifying patients at risk for clinically significant cardiac dysfunction following a myocardial infarction and the ability to isolate and infuse via the affected coronary circulation an autologous bone marrow derived CD34+ cell product at four dose levels.

The secondary objective of the study is to assess the effect on cardiac function and infarct region perfusion. A concurrent patient group meeting eligibility but not receiving CD34+ cells will be evaluated similar to the treated group to assess the rate of significant spontaneous improvement in cardiac function without CD34+cell infusion.


Options:
A: Inclusion Criteria:

* patient included in one of the registered cell-based cardiac therapy of the participating center

Exclusion Criteria:

* none
B: Inclusion Criteria:

* Age 18 - 75 years.
* Acute ST elevation myocardial infarction meeting ACC/AHA criteria, with symptoms of chest pain within 3 days of admission. Criteria include (ST elevation \> 1mm in limb leads or 2 mm in two or more precordial leads and increased levels of troponin, CPK MB or both)
* NYHA heart failure class of I, II or III

Exclusion Criteria:

* Patients who are not candidates for percutaneous intervention, conscious sedation, MRI, SPECT imaging or mini-bone marrow harvest
* History of sustained chest pain unrelieved by nitrates, occurring 4 or more days before revascularization.
* Patients who fail to re-perfuse the infarct related coronary artery or have successful stent placement
C: 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.
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: B