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Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI
This study is currently recruiting participants.
Verified by Stempeutics Research Pvt Ltd, April 2009
First Received: April 17, 2009   Last Updated: April 20, 2009   History of Changes
Sponsored by: Stempeutics Research Pvt Ltd
Information provided by: Stempeutics Research Pvt Ltd
ClinicalTrials.gov Identifier: NCT00883727
  Purpose

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


Condition Intervention Phase
Myocardial Infarction
Drug: Stem cell
Drug: Plasmalyte A
Phase I
Phase II

MedlinePlus related topics: Heart Attack
Drug Information available for: Normosol R
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Stempeutics Research Pvt Ltd:

Primary Outcome Measures:
  • AE and ECG parameters [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Regional myocardial perfusion and infarct size [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
stem cells: Experimental Drug: Stem cell
IV infusion of stem cells
Placebo: Placebo Comparator Drug: Plasmalyte A
IV infusion

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883727

Contacts
Contact: Radhika C Radhakrishnan, MD 918025024611 radhika.cr@stempeutics.com
Contact: Pawan K Gupta, PhD 918025024611 pawan.kumarg@manipal.edu

Locations
India, Andhra Pradesh
Care Hospital Recruiting
Hyderabad, Andhra Pradesh, India, 500034
Principal Investigator: Sreenivas Kumar, MD, DM            
India, Gujarat
SAL Hospital and Medical Institute Not yet recruiting
Ahmedabad, Gujarat, India, 380054
Principal Investigator: Satya Gupta, MD, DM            
India, Karnataka
Bhagawan Mahaveer Jain Heart Centre Recruiting
Bangalore, Karnataka, India, 5660052
Principal Investigator: R Keshava, MD, DM            
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
  More Information

No publications provided

Responsible Party: Stempeutics Research Private Limited ( President )
Study ID Numbers: SRPL/AMI/07-08/001
Study First Received: April 17, 2009
Last Updated: April 20, 2009
ClinicalTrials.gov Identifier: NCT00883727     History of Changes
Health Authority: India: Drugs Controller General of India

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

Study placed in the following topic categories:
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 06, 2009