NCT03047772

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

The Randomized Double-blind Placebo-Controlled Multi-center Clinical Trial of Transplantation Efficacy of Autologous Bone Marrow Mesenchymal Stem Cells With Intensive Atorvastatin in Acute Myocardial Infarction Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Yuejin Yang · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction
• Stem Cell Transplantation
• Angioplasty, Transluminal, Percutaneous Coronary

Interventions

Type	Name	Description
DRUG	Atorvastatin	Routine dose of Atorvastatin therapy
DRUG	Intensive Atorvastatin	Intensive dose of Atorvastatin therapy
DRUG	Low dose BMMSC	Low dose autologous Bone Marrow Mesenchymal Stem Cells transplantation
DRUG	Middle dose BMMSC	Middle dose autologous Bone Marrow Mesenchymal Stem Cells transplantation
DRUG	High dose BMMSC	High dose autologous Bone Marrow Mesenchymal Stem Cells transplantation
DRUG	Transplantation	Optimal dose autologous Bone Marrow Mesenchymal Stem Cells transplantation

Timeline

• Start date: 2018-03-06
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2017-02-09
• Last updated: 2018-01-25