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
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


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 ]

Enrollment: 20
Study Start Date: April 2009
Study Completion Date: August 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: stem cells Drug: Stem cell
IV infusion of stem cells
Placebo Comparator: Placebo 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883727

Locations
India
Care Hospital
Hyderabad, Andhra Pradesh, India, 500034
SAL Hospital and Medical Institute
Ahmedabad, Gujarat, India, 380054
Bhagawan Mahaveer Jain Heart Centre
Bangalore, Karnataka, India, 5660052
MS Ramaiah Memorial Hospital
Bangalore, Karnataka, India, 560054
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
  More Information

No publications provided

Responsible Party: Stempeutics Research Pvt Ltd
ClinicalTrials.gov Identifier: NCT00883727     History of Changes
Other Study ID Numbers: SRPL/AMI/07-08/001
Study First Received: April 17, 2009
Last Updated: March 4, 2013
Health Authority: India: Drugs Controller General of India

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

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

ClinicalTrials.gov processed this record on August 28, 2014