Status:
COMPLETED
Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI
Lead Sponsor:
Stempeutics Research Pvt Ltd
Conditions:
Myocardial Infarction
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells in patients with myocardial infarction.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00883727
Start Date
April 1 2009
End Date
August 1 2012
Last Update
March 5 2013
Active Locations (4)
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1
Care Hospital
Hyderabad, Andhra Pradesh, India, 500034
2
SAL Hospital and Medical Institute
Ahmedabad, Gujarat, India, 380054
3
MS Ramaiah Memorial Hospital
Bangalore, Karnataka, India, 560054
4
Bhagawan Mahaveer Jain Heart Centre
Bangalore, Karnataka, India, 5660052