Transplantation Efficacy of Autologous Bone Marrow Mesenchymal Stem Cells With Intensive Atorvastatin in AMI Patients (TEAM-AMI)

Yuejin Yang

Status and phase: Unknown; Phase 2

Conditions: Stem Cell Transplantation; Angioplasty, Transluminal, Percutaneous Coronary; Myocardial Infarction

Treatments: Drug: High dose BMMSC; Drug: Transplantation; Drug: Intensive Atorvastatin; Drug: Low dose BMMSC; Drug: Atorvastatin; Drug: Middle dose BMMSC

Study type: Interventional

Funder types: Other

Identifiers

NCT03047772

2016-807-10.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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124 participants in 8 patient groups, including a placebo group

Phase A: Atorvastatin

Placebo Comparator group

Description:

Atorvastatin routine dose + placebo transplantation

Treatment:

Drug: Atorvastatin

Phase A: Low dose BMMSC

Experimental group

Description:

Atorvastatin routine dose + low dose BMMSC Transplantation

Treatment:

Drug: Low dose BMMSC

Drug: Atorvastatin

Phase A: Middle dose BMMSC

Experimental group

Description:

Atorvastatin routine dose + middle dose BMMSC Transplantation

Treatment:

Drug: Middle dose BMMSC

Drug: Atorvastatin

Phase A: High dose BMMSC

Experimental group

Description:

Atorvastatin routine dose + high dose BMMSC Transplantation

Treatment:

Drug: Atorvastatin

Drug: High dose BMMSC

Phase B: Atorvastatin

Placebo Comparator group

Description:

Atorvastatin routine dose + placebo transplantation

Treatment:

Drug: Atorvastatin

Phase B: Atorvastatin+Transplantation

Active Comparator group

Description:

Atorvastatin routine dose+ Optimal dose BMMSC Transplantation

Treatment:

Drug: Atorvastatin

Drug: Transplantation

Phase B: Intensive Atorvastatin

Placebo Comparator group

Description:

Atorvastatin Intensive dose + placebo transplantation

Treatment:

Drug: Intensive Atorvastatin

Phase B: Intensive Atorvastatin+Transplantation

Experimental group

Description:

Atorvastatin Intensive dose + Optimal dose BMMSC Transplantation

Treatment:

Drug: Transplantation

Drug: Intensive Atorvastatin