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Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI

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ClinicalTrials.gov Identifier: NCT00883727
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : March 5, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Stem cell Drug: Plasmalyte A Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : April 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: stem cells Drug: Stem cell
IV infusion of stem cells

Placebo Comparator: Placebo Drug: Plasmalyte A
IV infusion




Primary Outcome Measures :
  1. AE and ECG parameters [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Regional myocardial perfusion and infarct size [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883727


Locations
India
Care Hospital
Hyderabad, Andhra Pradesh, India, 500034
SAL Hospital and Medical Institute
Ahmedabad, Gujarat, India, 380054
MS Ramaiah Memorial Hospital
Bangalore, Karnataka, India, 560054
Bhagawan Mahaveer Jain Heart Centre
Bangalore, Karnataka, India, 5660052
Sponsors and Collaborators
Stempeutics Research Pvt Ltd
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stempeutics Research Pvt Ltd
ClinicalTrials.gov Identifier: NCT00883727     History of Changes
Other Study ID Numbers: SRPL/AMI/07-08/001
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013

Keywords provided by Stempeutics Research Pvt Ltd:
mesenchymal stem cells
myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Ischemia
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions