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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-06

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myocardial Infarction Stem Cell Transplantation Angioplasty, Transluminal, Percutaneous Coronary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Intervention Type DRUG

Optimal dose autologous Bone Marrow Mesenchymal Stem Cells transplantation

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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

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No