Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stempeutics Research Pvt Ltd
• Treatments: Plasma-lyte 148

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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