A randomized, double blind, multicentric, placebo controlled, single dose, phase I/II study assessing the safety and efficacy of intravenous ex vivo cultured adult allogenic mesenchymal stem cells in patients with ST elevated acute myocardial infarction (STEMI)

Stempeutics Research Pvt Ltd0 个研究点目标入组 20 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•a) Patients with STEMI aged between 20 and 70 years, either males or females with non-child bearing potential, after 2 days of successful PCI.
•b) Patient has global left ventricular systolic dysfunction with an ejection fraction of
•<50% and >30%.
•c) ECG with sign of acute anterior MI with ST-elevation ≥ 2 mm in at least 2 of the following leads I, AVL, V1-V6, or ECG with sign of acute inferoposterior MI with ST elevation ≥1 mm on all of the following leads- II, III, V5-V6 or STelevation ≥ 2 mm in at least 2 of the leads.
•d) The target lesion located in the proximal section of the left anterior descending, left circumflex or right coronary artery.
•e) Patient with acute myocardial infarction within 10 days prior to IP administration.
•f) Normal liver and renal function.
•g) Able to understand study information provided to him.
•h) Able to give voluntary written consent.

•a) History of acute/chronic inflammatory condition or severe aortic stenosis or insufficiency; severe mitral stenosis or severe mitral insufficiency.
•b) Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
•c) Advanced renal dysfunction and creatinine ≥ 2mg%.
•d) Advanced hepatic dysfunction.
•e) Have clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
•f) Previous MI.
•g) Patients already enrolled in another investigational drug trial.
•h) History of severe alcohol or drug abuse within 3 months of screening.
•i) Women with child bearing potential or who are pregnant or lactating.
•j) Having tested positive for HIV 1, HCV, HBV, syphilis and CMV(IgM).
•k) Patients contraindicated for MRI.

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