Clinical trial NCT03047772: Transplantation Efficacy of Autologous Bone Marrow Mesenchymal Stem Cells With Intensive Atorvastatin in AMI Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Myocardial Infarction
Stem Cell Transplantation
Angioplasty, Transluminal, Percutaneous Coronary
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: The First Hospital of Hebei Medical University
name: Zunyi Medical College
First posted: 2017-02-09
Enrollment: 124
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Changes in left ventricular ejection fraction from baseline to 12 months'
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Xu JY, Qian HY, Huang PS, Xu J, Xiong YY, Jiang WY, Xu Y, Leng WX, Li XD, Chen GH, Tang RJ, Huang CR, Hu MJ, Jin C, Wu Y, Zhang J, Qian J, Xu B, Zhao SH, Lu MJ, Shen R, Fang W, Wu WC, Chen X, Wang Y, Li W, Lu XF, Jiang XF, Ma CC, Li JW, Geng YJ, Qiao SB, Gao RL, Yang YJ. Transplantation efficacy of autologous bone marrow mesenchymal stem cells combined with atorvastatin for acute myocardial infarction (TEAM-AMI): rationale and design of a randomized, double-blind, placebo-controlled, multi-center, Phase II TEAM-AMI trial. Regen Med. 2019 Dec;14(12):1077-1087. doi: 10.2217/rme-2019-0024. Epub 2019 Dec 12.