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
; 14(12): 1077-1087, 2019 12.
Article
em En
| MEDLINE
| ID: mdl-31829095
ABSTRACT
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 (1111) 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.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
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Transplante de Medula Óssea
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Células-Tronco Mesenquimais
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Atorvastatina
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Infarto do Miocárdio
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article