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 Ltd4 sites in 1 country20 target enrollmentApril 2009

Overview

This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells in patients with myocardial infarction.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

August 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Patients with STEMI aged between 20 and 70 years, either males or females with non-child bearing potential, after 2 days of successful PCI.
•Patient has global left ventricular systolic dysfunction with an ejection fraction of \<50% and \>30%.
•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.
•The target lesion located in the proximal section of the left anterior descending, left circumflex or right coronary artery.
•Patient with acute myocardial infarction within 10 days prior to IP administration.
•Normal liver and renal function.
•Able to understand study information provided to him.
•Able to give voluntary written consent.

•History of acute/chronic inflammatory condition or severe aortic stenosis or insufficiency; severe mitral stenosis or severe mitral insufficiency.
•Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
•Advanced renal dysfunction and creatinine ≥ 2mg%.
•Advanced hepatic dysfunction.
•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