Overview

Transplantation Efficacy of Autologous Bone Marrow Mesenchymal Stem Cells With Intensive Atorvastatin in AMI Patients

Status:
Unknown status
Trial end date:
2018-12-31
Target enrollment:
0
Participant gender:
All
Summary
The benefit of current stem cell transplantation therapy for myocardial infarction is limited by low survival rate for stem cell. The purpose of this study is to test whether intensive Atorvastatin therapy can improve the outcome of patients with impaired left ventricle function after acute myocardial infarction who underwent intracoronary transfer of autologous bone marrow mesenchymal stem cells.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yuejin Yang
Collaborators:
Peking Union Medical College Hospital
The First Hospital of Hebei Medical University
Zunyi Medical College
Treatments:
Atorvastatin
Atorvastatin Calcium
Criteria
Inclusion Criteria:

1. Patients with the first time ST-elevation myocardial infarction (STEMI).

2. Patients after undergoing PCI 2 to 5 days.

3. Patients without PCI but emergency coronary angiography shows the criminal coronary
artery recanalized.

4. Left ventricular infarction area seriously hypokinesis or no movement

5. Left ventricular ejection fraction <=45% based on coronary angiography or
echocardiography.

Exclusion Criteria:

Any one of the following exclusion criteria is sufficient to disqualify a patient from the
study.

1. Patients without emergency PCI and the criminal coronary artery fail to be
recanalized.

2. Patients with non-ST-elevation myocardial infarction.

3. Patients with normal left ventricular function.

4. Patients with mechanical complications of myocardial infarction.

5. Patients with a malignant tumor.

6. Patients with infection disease.

7. Less than 6 months since last episode of stroke.

8. Patients with hematological disease (leukemia, myeloproliferative disease, or
myelodysplastic syndromes).

9. ALT (GPT) exceeding 100 IU/L.

10. Leukocytes less than 4,000/µL or exceeding 10,000/µL.

11. Platelets less than 100,000/µL.

12. Hemoglobin less than 10 g/dL.

13. Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming
pregnant before the end of the study period.

14. Any other reason that the Clinical Supervisors or Clinical Researchers may have for
considering a case unsuitable for the study.