Skip to main content
Clinical Trials/NCT03047772
NCT03047772
Unknown
Phase 2

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

Yuejin Yang0 sites124 target enrollmentMarch 6, 2018

Overview

Phase
Phase 2
Intervention
Middle dose BMMSC
Conditions
Myocardial Infarction
Sponsor
Yuejin Yang
Enrollment
124
Primary Endpoint
Changes in left ventricular ejection fraction from baseline to 12 months'
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 6, 2018
End Date
December 31, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Yuejin Yang
Responsible Party
Sponsor Investigator
Principal Investigator

Yuejin Yang

Vice Dean of Fuwai hospital

Chinese Academy of Medical Sciences, Fuwai Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with the first time ST-elevation myocardial infarction (STEMI).
  • Patients after undergoing PCI 2 to 5 days.
  • Patients without PCI but emergency coronary angiography shows the criminal coronary artery recanalized.
  • Left ventricular infarction area seriously hypokinesis or no movement
  • 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.
  • Patients without emergency PCI and the criminal coronary artery fail to be recanalized.
  • Patients with non-ST-elevation myocardial infarction.
  • Patients with normal left ventricular function.
  • Patients with mechanical complications of myocardial infarction.
  • Patients with a malignant tumor.
  • Patients with infection disease.
  • Less than 6 months since last episode of stroke.
  • Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
  • ALT (GPT) exceeding 100 IU/L.

Arms & Interventions

Phase A: Middle dose BMMSC

Atorvastatin routine dose + middle dose BMMSC Transplantation

Intervention: Middle dose BMMSC

Phase A: Atorvastatin

Atorvastatin routine dose + placebo transplantation

Intervention: Atorvastatin

Phase A: Low dose BMMSC

Atorvastatin routine dose + low dose BMMSC Transplantation

Intervention: Atorvastatin

Phase A: Low dose BMMSC

Atorvastatin routine dose + low dose BMMSC Transplantation

Intervention: Low dose BMMSC

Phase A: Middle dose BMMSC

Atorvastatin routine dose + middle dose BMMSC Transplantation

Intervention: Atorvastatin

Phase A: High dose BMMSC

Atorvastatin routine dose + high dose BMMSC Transplantation

Intervention: Atorvastatin

Phase A: High dose BMMSC

Atorvastatin routine dose + high dose BMMSC Transplantation

Intervention: High dose BMMSC

Phase B: Atorvastatin

Atorvastatin routine dose + placebo transplantation

Intervention: Atorvastatin

Phase B: Atorvastatin+Transplantation

Atorvastatin routine dose+ Optimal dose BMMSC Transplantation

Intervention: Atorvastatin

Phase B: Atorvastatin+Transplantation

Atorvastatin routine dose+ Optimal dose BMMSC Transplantation

Intervention: Transplantation

Phase B: Intensive Atorvastatin

Atorvastatin Intensive dose + placebo transplantation

Intervention: Intensive Atorvastatin

Phase B: Intensive Atorvastatin+Transplantation

Atorvastatin Intensive dose + Optimal dose BMMSC Transplantation

Intervention: Intensive Atorvastatin

Phase B: Intensive Atorvastatin+Transplantation

Atorvastatin Intensive dose + Optimal dose BMMSC Transplantation

Intervention: Transplantation

Outcomes

Primary Outcomes

Changes in left ventricular ejection fraction from baseline to 12 months'

Time Frame: 12 months

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

Similar Trials

Completed
Phase 2
Strengthening Transplantation Effects of Bone Marrow Mononuclear Cells With Atorvastatin in Myocardial InfarctionMyocardial InfarctionStem Cell TransplantationAngioplasty, Transluminal, Percutaneous Coronary
NCT00979758Chinese Academy of Medical Sciences, Fuwai Hospital100
Completed
Phase 2
Bone Marrow-Derived Stem Cell Transfer in Acute Myocardial InfarctionsMyocardial Infarction
NCT00264316Universitaire Ziekenhuizen KU Leuven68
Terminated
Phase 3
Moxifloxacin in Preventing Bacterial Infections in Patients Who Have Undergone Donor Stem Cell TransplantBreast CancerChronic Myeloproliferative DisordersGestational Trophoblastic TumorInfectionLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsNeuroblastomaOvarian CancerTesticular Germ Cell Tumor
NCT00324324OHSU Knight Cancer Institute240
Completed
Phase 2
Stem Cell Therapy in IschEmic Non-treatable Cardiac DiseaseHeart Failure
NCT02673164JKastrup133
Active, not recruiting
Phase 1
CML-SCT -IBFM StudyAllogeneic stem cell transplantation for children and Adolescents with CML: Conditioning regimen, donor selection, supportive care and diagnostic procedures. - CML-SCTChildren and adolecents with chronic myeloid leukemia with indication for allogeneic stem cell transplantationMedDRA version: 14.0Level: LLTClassification code 10009700Term: CMLSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
EUCTR2008-000569-50-CZSt Anna Kinderkrebsforschung160