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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03047772
Acronym
TEAM-AMI
Enrollment
124
Registered
2017-02-09
Start date
2018-03-06
Completion date
2018-12-31
Last updated
2018-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGHigh dose BMMSC

High dose autologous Bone Marrow Mesenchymal Stem Cells transplantation

DRUGTransplantation

Optimal dose autologous Bone Marrow Mesenchymal Stem Cells transplantation

DRUGAtorvastatin

Routine dose of Atorvastatin therapy

DRUGIntensive Atorvastatin

Intensive dose of Atorvastatin therapy

DRUGLow dose BMMSC

Low dose autologous Bone Marrow Mesenchymal Stem Cells transplantation

DRUGMiddle dose BMMSC

Middle dose autologous Bone Marrow Mesenchymal Stem Cells transplantation

Sponsors

Peking Union Medical College Hospital
CollaboratorOTHER
The First Hospital of Hebei Medical University
CollaboratorOTHER
Zunyi Medical College
CollaboratorOTHER
Yuejin Yang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in left ventricular ejection fraction from baseline to 12 months'12 monthsChanges in left ventricular ejection fraction from baseline to 12 months' by MRI

Contacts

Primary ContactHaiyan Qian, Doctor
ahqhy712@163.com861068314466

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026