Key result
The TEAM-AMI trial is a phase II study designed to evaluate intracoronary infusion of autologous bone marrow mesenchymal stem cells combined with atorvastatin for anterior STEMI; results are pending.
Why the study?
To determine the efficacy and safety of intracoronary autologous bone marrow mesenchymal stem cell infusion combined with intensive atorvastatin treatment in anterior STEMI.
Does intracoronary infusion of autologous bone marrow mesenchymal stem cells combined with intensive atorvastatin improve left ventricular ejection fraction in patients with anterior ST-segment elevation myocardial infarction?
RCT (n=100)
Double-Blind
1:1:1:1
Yes
Does intracoronary infusion of autologous bone marrow mesenchymal stem cells combined with intensive atorvastatin improve left ventricular ejection fraction in patients with anterior ST-segment elevation myocardial infarction?
The TEAM-AMI trial will evaluate whether optimizing the cardiac microenvironment with intensive atorvastatin enhances the efficacy of intracoronary mesenchymal stem cell therapy in anterior STEMI patients.
Aim: To determine the efficacy and safety of intracoronary infusion of autologous bone marrow mesenchymal stem cells (MSCINJ) in combination with intensive atorvastatin (ATV) treatment for patients with anterior ST-segment elevation myocardial infarction-elevation myocardial infarction. Patients & methods: The trial enrolls a total of 100 patients with anterior ST-elevation myocardial infarction. The subjects are randomly assigned (1:1:1:1) to receive routine ATV (20 mg/d) with placebo or MSCsINJ and intensive ATV (80 mg/d) with placebo or MSCsINJ. The primary end point is the absolute change of left ventricular ejection fraction within 12 months. The secondary end points include parameters in cardiac function, remodeling and regeneration, quality of life, biomarkers and clinical outcomes. Results & conclusion: The trial will implicate the essential of cardiac micro-environment improvement (‘fertilizing’) for cell-based therapy. Clinical Trial Registration: NCT03047772.
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Xu et al. (2019) conducted an RCT in anterior ST-segment elevation myocardial infarction (n=100). Autologous bone marrow mesenchymal stem cells (MSCINJ) combined with atorvastatin vs. Placebo + atorvastatin 20 mg/d or 80 mg/d was evaluated on Absolute change of left ventricular ejection fraction within 12 months. The TEAM-AMI trial is a phase II study designed to evaluate intracoronary infusion of autologous bone marrow mesenchymal stem cells combined with atorvastatin for anterior STEMI; results are pending.
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