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

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ClinicalTrials.gov Identifier: NCT03047772
Recruitment Status : Not yet recruiting
First Posted : February 9, 2017
Last Update Posted : January 25, 2018
Sponsor:
Collaborators:
Peking Union Medical College Hospital
The First Hospital of Hebei Medical University
Zunyi Medical College
Information provided by (Responsible Party):
Yuejin Yang, Chinese Academy of Medical Sciences, Fuwai Hospital

Tracking Information
First Submitted Date  ICMJE February 7, 2017
First Posted Date  ICMJE February 9, 2017
Last Update Posted Date January 25, 2018
Estimated Study Start Date  ICMJE March 6, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03047772 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transplantation Efficacy of Autologous Bone Marrow Mesenchymal Stem Cells With Intensive Atorvastatin in AMI Patients
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Myocardial Infarction
  • Stem Cell Transplantation
  • Angioplasty, Transluminal, Percutaneous Coronary
Intervention  ICMJE
  • Drug: Atorvastatin
    Routine dose of Atorvastatin therapy
    Other Name: Statin
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Phase A: Atorvastatin
    Atorvastatin routine dose + placebo transplantation
    Intervention: Drug: Atorvastatin
  • Experimental: Phase A: Low dose BMMSC
    Atorvastatin routine dose + low dose BMMSC Transplantation
    Interventions:
    • Drug: Atorvastatin
    • Drug: Low dose BMMSC
  • Experimental: Phase A: Middle dose BMMSC
    Atorvastatin routine dose + middle dose BMMSC Transplantation
    Interventions:
    • Drug: Atorvastatin
    • Drug: Middle dose BMMSC
  • Experimental: Phase A: High dose BMMSC
    Atorvastatin routine dose + high dose BMMSC Transplantation
    Interventions:
    • Drug: Atorvastatin
    • Drug: High dose BMMSC
  • Placebo Comparator: Phase B: Atorvastatin
    Atorvastatin routine dose + placebo transplantation
    Intervention: Drug: Atorvastatin
  • Active Comparator: Phase B: Atorvastatin+Transplantation
    Atorvastatin routine dose+ Optimal dose BMMSC Transplantation
    Interventions:
    • Drug: Atorvastatin
    • Drug: Transplantation
  • Placebo Comparator: Phase B: Intensive Atorvastatin
    Atorvastatin Intensive dose + placebo transplantation
    Intervention: Drug: Intensive Atorvastatin
  • Experimental: Phase B: Intensive Atorvastatin+Transplantation
    Atorvastatin Intensive dose + Optimal dose BMMSC Transplantation
    Interventions:
    • Drug: Intensive Atorvastatin
    • Drug: Transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2017)
124
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Haiyan Qian, Doctor 861068314466 ahqhy712@163.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03047772
Other Study ID Numbers  ICMJE 2016-807-10.1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yuejin Yang, Chinese Academy of Medical Sciences, Fuwai Hospital
Study Sponsor  ICMJE Yuejin Yang
Collaborators  ICMJE
  • Peking Union Medical College Hospital
  • The First Hospital of Hebei Medical University
  • Zunyi Medical College
Investigators  ICMJE Not Provided
PRS Account Chinese Academy of Medical Sciences, Fuwai Hospital
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP