Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI

Phase 1

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: Stem cell; Drug: Plasmalyte A

• Registration Number: NCT00883727
• Lead Sponsor: Stempeutics Research Pvt Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-04-17
• Study First Posted: 2009-04-20
• Primary Completion: 2010-05
• Study Completion: 2012-08
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-04
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stem cells	Stem cell	-
Placebo	Plasmalyte A	-

Primary Outcome Measures

Name	Time	Method
AE and ECG parameters	6 months

Secondary Outcome Measures

Name	Time	Method
Regional myocardial perfusion and infarct size	6 months

Trial Locations

Locations (4)

Care Hospital; 🇮🇳 Hyderabad, Andhra Pradesh, India

SAL Hospital and Medical Institute; 🇮🇳 Ahmedabad, Gujarat, India

MS Ramaiah Memorial Hospital; 🇮🇳 Bangalore, Karnataka, India

Bhagawan Mahaveer Jain Heart Centre; 🇮🇳 Bangalore, Karnataka, India