- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00883727
Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI
March 4, 2013 updated by: Stempeutics Research Pvt Ltd
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Andhra Pradesh
-
Hyderabad, Andhra Pradesh, India, 500034
- Care Hospital
-
-
Gujarat
-
Ahmedabad, Gujarat, India, 380054
- Sal Hospital and Medical Institute
-
-
Karnataka
-
Bangalore, Karnataka, India, 560054
- MS Ramaiah Memorial Hospital
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Bangalore, Karnataka, India, 5660052
- Bhagawan Mahaveer Jain Heart Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
IV infusion
|
Experimental: stem cells
|
IV infusion of stem cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AE and ECG parameters
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Regional myocardial perfusion and infarct size
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
April 17, 2009
First Submitted That Met QC Criteria
April 17, 2009
First Posted (Estimate)
April 20, 2009
Study Record Updates
Last Update Posted (Estimate)
March 5, 2013
Last Update Submitted That Met QC Criteria
March 4, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRPL/AMI/07-08/001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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