Transplantation Efficacy of Autologous Bone Marrow Mesenchymal Stem Cells With Intensive Atorvastatin in AMI Patients
TEAM-AMI
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
1 other identifier
interventional
124
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2018
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2017
CompletedFirst Posted
Study publicly available on registry
February 9, 2017
CompletedStudy Start
First participant enrolled
March 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJanuary 25, 2018
January 1, 2018
10 months
February 7, 2017
January 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in left ventricular ejection fraction from baseline to 12 months'
Changes in left ventricular ejection fraction from baseline to 12 months' by MRI
12 months
Study Arms (8)
Phase A: Atorvastatin
PLACEBO COMPARATORAtorvastatin routine dose + placebo transplantation
Phase A: Low dose BMMSC
EXPERIMENTALAtorvastatin routine dose + low dose BMMSC Transplantation
Phase A: Middle dose BMMSC
EXPERIMENTALAtorvastatin routine dose + middle dose BMMSC Transplantation
Phase A: High dose BMMSC
EXPERIMENTALAtorvastatin routine dose + high dose BMMSC Transplantation
Phase B: Atorvastatin
PLACEBO COMPARATORAtorvastatin routine dose + placebo transplantation
Phase B: Atorvastatin+Transplantation
ACTIVE COMPARATORAtorvastatin routine dose+ Optimal dose BMMSC Transplantation
Phase B: Intensive Atorvastatin
PLACEBO COMPARATORAtorvastatin Intensive dose + placebo transplantation
Phase B: Intensive Atorvastatin+Transplantation
EXPERIMENTALAtorvastatin Intensive dose + Optimal dose BMMSC Transplantation
Interventions
Routine dose of Atorvastatin therapy
Intensive dose of Atorvastatin therapy
Low dose autologous Bone Marrow Mesenchymal Stem Cells transplantation
Middle dose autologous Bone Marrow Mesenchymal Stem Cells transplantation
High dose autologous Bone Marrow Mesenchymal Stem Cells transplantation
Optimal dose autologous Bone Marrow Mesenchymal Stem Cells transplantation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Leukocytes less than 4,000/µL or exceeding 10,000/µL.
- Platelets less than 100,000/µL.
- Hemoglobin less than 10 g/dL.
- Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
- Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yuejin Yanglead
- Peking Union Medical College Hospitalcollaborator
- The First Hospital of Hebei Medical Universitycollaborator
- Zunyi Medical Collegecollaborator
Related Publications (1)
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.
PMID: 31829095DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Vice Dean of Fuwai hospital
Study Record Dates
First Submitted
February 7, 2017
First Posted
February 9, 2017
Study Start
March 6, 2018
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
January 25, 2018
Record last verified: 2018-01