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Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stempeutics Research Pvt Ltd
ClinicalTrials.gov Identifier:
NCT00883727
First received: April 17, 2009
Last updated: March 4, 2013
Last verified: March 2013

April 17, 2009
March 4, 2013
April 2009
May 2010   (final data collection date for primary outcome measure)
AE and ECG parameters [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00883727 on ClinicalTrials.gov Archive Site
Regional myocardial perfusion and infarct size [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI
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)

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Myocardial Infarction
  • Drug: Stem cell
    IV infusion of stem cells
  • Drug: Plasmalyte A
    IV infusion
  • Experimental: stem cells
    Intervention: Drug: Stem cell
  • Placebo Comparator: Placebo
    Intervention: Drug: Plasmalyte A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2012
May 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00883727
SRPL/AMI/07-08/001
Yes
Stempeutics Research Pvt Ltd
Stempeutics Research Pvt Ltd
Not Provided
Principal Investigator: Sreenivas Kumar, MD, DM Care Hospital, Hyderabad
Principal Investigator: Satya Gupta SAL Hospital, Ahmedabad
Principal Investigator: R Keshava, MD, DM Bhagwan Mahaveer JAin Hospital, Bangalore
Principal Investigator: Prakash VS, MD., DM MS Ramaiah Memorial Hospital, Bangalore
Stempeutics Research Pvt Ltd
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP