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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

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Stem Cell Transplantation Angioplasty, Transluminal, Percutaneous Coronary Drug: Atorvastatin Drug: Intensive Atorvastatin Drug: Low dose BMMSC Drug: Middle dose BMMSC Drug: High dose BMMSC Drug: Transplantation Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : March 6, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Placebo Comparator: Phase A: Atorvastatin
Atorvastatin routine dose + placebo transplantation
Drug: Atorvastatin
Routine dose of Atorvastatin therapy
Other Name: Statin

Experimental: Phase A: Low dose BMMSC
Atorvastatin routine dose + low dose BMMSC Transplantation
Drug: Atorvastatin
Routine dose of Atorvastatin therapy
Other Name: Statin

Drug: Low dose BMMSC
Low dose autologous Bone Marrow Mesenchymal Stem Cells transplantation

Experimental: Phase A: Middle dose BMMSC
Atorvastatin routine dose + middle dose BMMSC Transplantation
Drug: Atorvastatin
Routine dose of Atorvastatin therapy
Other Name: Statin

Drug: Middle dose BMMSC
Middle dose autologous Bone Marrow Mesenchymal Stem Cells transplantation

Experimental: Phase A: High dose BMMSC
Atorvastatin routine dose + high dose BMMSC Transplantation
Drug: Atorvastatin
Routine dose of Atorvastatin therapy
Other Name: Statin

Drug: High dose BMMSC
High dose autologous Bone Marrow Mesenchymal Stem Cells transplantation

Placebo Comparator: Phase B: Atorvastatin
Atorvastatin routine dose + placebo transplantation
Drug: Atorvastatin
Routine dose of Atorvastatin therapy
Other Name: Statin

Active Comparator: Phase B: Atorvastatin+Transplantation
Atorvastatin routine dose+ Optimal dose BMMSC Transplantation
Drug: Atorvastatin
Routine dose of Atorvastatin therapy
Other Name: Statin

Drug: Transplantation
Optimal dose autologous Bone Marrow Mesenchymal Stem Cells transplantation

Placebo Comparator: Phase B: Intensive Atorvastatin
Atorvastatin Intensive dose + placebo transplantation
Drug: Intensive Atorvastatin
Intensive dose of Atorvastatin therapy

Experimental: Phase B: Intensive Atorvastatin+Transplantation
Atorvastatin Intensive dose + Optimal dose BMMSC Transplantation
Drug: Intensive Atorvastatin
Intensive dose of Atorvastatin therapy

Drug: Transplantation
Optimal dose autologous Bone Marrow Mesenchymal Stem Cells transplantation




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047772


Contacts
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Contact: Haiyan Qian, Doctor 861068314466 ahqhy712@163.com

Sponsors and Collaborators
Yuejin Yang
Peking Union Medical College Hospital
The First Hospital of Hebei Medical University
Zunyi Medical College

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Responsible Party: Yuejin Yang, Vice Dean of Fuwai hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03047772     History of Changes
Other Study ID Numbers: 2016-807-10.1
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

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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
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors