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

Phase 2

• Conditions: Stem Cell Transplantation; Angioplasty, Transluminal, Percutaneous Coronary; Myocardial Infarction
• Interventions: Drug: Intensive Atorvastatin; Drug: Atorvastatin; Drug: High dose BMMSC; Drug: Low dose BMMSC; Drug: Transplantation; Drug: Middle dose BMMSC

• Registration Number: NCT03047772
• Lead Sponsor: Yuejin Yang

Brief 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.

Detailed Description

The major challenge to a successful stem cell therapy for myocardial infarction is the low survival rate of implanted cells in the damaged tissue. Atorvastatin, an HMG-CoA reductase inhibitor, has multiple biological activities independent of cholesterol-lowering action.This study is performed to find out more information about the strategy with Atorvastatin therapy to improve the survival of implanted cells, autologous bone marrow mesenchymal stem cells transplantation. Patients between 30 and 75 years of age who receive autologous bone marrow mesenchymal stem cells transplant may be eligible for this study. These patients receive autologous bone marrow mesenchymal stem cells transplantation intracoronary undergoing Percutaneous Coronary Intervention with regular or high dose of Atorvastatin treatment. The objective evaluations will be performed at baseline and during 12 months follow-up.

Heart function tests may include the following:

Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.

Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of the heart and examine the function of the heart chambers and valves.

Gated acquisition scan is a nuclear medicine test that uses a small amount of radioactive chemical injected into a vein. A special scanner creates an image of the heart for examining the beating motion of the muscle.

MRI evaluates function of the heart chambers the beating motion of the muscle.

Study Timeline

• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25
• Study Start: 2018-03-06
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Phase B: Intensive Atorvastatin+Transplantation	Intensive Atorvastatin	Atorvastatin Intensive dose + Optimal dose BMMSC Transplantation
Phase A: High dose BMMSC	High dose BMMSC	Atorvastatin routine dose + high dose BMMSC Transplantation
Phase B: Intensive Atorvastatin	Intensive Atorvastatin	Atorvastatin Intensive dose + placebo transplantation
Phase A: Low dose BMMSC	Low dose BMMSC	Atorvastatin routine dose + low dose BMMSC Transplantation
Phase B: Atorvastatin+Transplantation	Transplantation	Atorvastatin routine dose+ Optimal dose BMMSC Transplantation
Phase B: Intensive Atorvastatin+Transplantation	Transplantation	Atorvastatin Intensive dose + Optimal dose BMMSC Transplantation
Phase A: Middle dose BMMSC	Middle dose BMMSC	Atorvastatin routine dose + middle dose BMMSC Transplantation
Phase A: Middle dose BMMSC	Atorvastatin	Atorvastatin routine dose + middle dose BMMSC Transplantation
Phase A: Atorvastatin	Atorvastatin	Atorvastatin routine dose + placebo transplantation
Phase A: Low dose BMMSC	Atorvastatin	Atorvastatin routine dose + low dose BMMSC Transplantation
Phase A: High dose BMMSC	Atorvastatin	Atorvastatin routine dose + high dose BMMSC Transplantation
Phase B: Atorvastatin	Atorvastatin	Atorvastatin routine dose + placebo transplantation
Phase B: Atorvastatin+Transplantation	Atorvastatin	Atorvastatin routine dose+ Optimal dose BMMSC Transplantation

Primary Outcome Measures

Name	Time	Method
Changes in left ventricular ejection fraction from baseline to 12 months'	12 months	Changes in left ventricular ejection fraction from baseline to 12 months' by MRI