Please select the eligibility criteria that correspond to the clinical trial below.
Title: Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction
Brief Summary: TITLE Intracoronary injection of CD133+ autologous hematopoietic cells after myocardial infarction.

TRIAL DESIGN Pilot phase I/II parallel group study, with an untreated control group.

SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction (AMI). TARGET POPULATION Patients (pts) with AMI treated with Primary Coronary Angioplasty (PTCA) with successful recanalization but unsuccessful reperfusion (myocardial blush (MB) grade 0 or 1 and less than 70% ST segment elevation resolution (STeR) (see Poli et al., Circulation, 2002).

OBJECTIVES Primary:

1. To evaluate the safety of intracoronary injection of CD133+ cells from autologous bone marrow (ABM) and mobilized peripheral blood (MPB) in the target population.
2. To evaluate the efficacy, of the selective injection of CD133+ cells from ABM and MPB in the culprit vessel of the target population, on regional and global contractile function and on perfusion and metabolism of the infarcted area, depending on cell dose and comparing to controls.

   Secondary:
3. To evaluate the disease-related morbility of the target population.


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:

* Informed consent;
* age: 18-65 years;
* large acute myocardial infarction (due to proximal occlusion of the left anterior descending or the right coronary artery) after successful primary PTCA carried out between the IV and the XXIV hour from the onset of AMI symptoms;
* signs of microvascular dysfunction in the infarcted area: absence of STeR and angiographic MB, graded according to the dye density score (see van't Hof et al., Circulation, 1998); life expectancy more than 6 months.

Exclusion Criteria:

* Pregnancy;
* indication to aorto-coronaric by-pass;
* neoplasia (previous or in progress);
* primary diseases of the BM;
* diabetes;
* immunosuppressive therapy;
* laboratory alterations of protein S, protein C, ATIII or Fibrinogen;
* severe co-morbidity.
C: Inclusion Criteria:

* Male or female between 21 and 85 years old
* First heart attack within 1 to 10 days

Exclusion Criteria:

* Positive for HIV 1 and 2
* Previous heart attack
* Pacemaker or other device
* Pregnant or breastfeeding
* Allergic to cow or pig derived products
* Previous bone marrow transplant
* Involved in another clinical trial within the past 30 days
* Alcohol or recreational drug abuse within the past 6 months
* Hepatitis Positive
* Major surgical procedure or major trauma within the past 14 days
* Body weight greater than 300 pounds
* Autoimmune disease ( e.g. Lupus, Multiple Sclerosis)
D: Inclusion Criteria:

* Clinical diagnosis of acute Myocardial Infarction(within one month);
* Age under 65;
* Infarction related wall motion abnormality on echocardiography;
* Infarction related TIMI flow grades 3 on coronary angiography during cell injection;
* Informed consent;

Exclusion Criteria:

* Active infection, or hematopoietic malignancy;
* Patients have tumor or other lethal diseases;
* Informed refusal

Answer: B