Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Stem cell
Plasmalyte A
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring mesenchymal stem cells, myocardial infarction
Eligibility 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
Sites / Locations
- Care Hospital
- SAL Hospital and Medical Institute
- MS Ramaiah Memorial Hospital
- Bhagawan Mahaveer Jain Heart Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
stem cells
Placebo
Arm Description
Outcomes
Primary Outcome Measures
AE and ECG parameters
Secondary Outcome Measures
Regional myocardial perfusion and infarct size
Full Information
NCT ID
NCT00883727
First Posted
April 17, 2009
Last Updated
March 4, 2013
Sponsor
Stempeutics Research Pvt Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00883727
Brief Title
Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI
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 Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stempeutics Research Pvt Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells in patients with myocardial infarction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
mesenchymal stem cells, myocardial infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stem cells
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Stem cell
Intervention Description
IV infusion of stem cells
Intervention Type
Drug
Intervention Name(s)
Plasmalyte A
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
AE and ECG parameters
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Regional myocardial perfusion and infarct size
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sreenivas Kumar, MD, DM
Organizational Affiliation
Care Hospital, Hyderabad
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Satya Gupta
Organizational Affiliation
SAL Hospital, Ahmedabad
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
R Keshava, MD, DM
Organizational Affiliation
Bhagwan Mahaveer JAin Hospital, Bangalore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prakash VS, MD., DM
Organizational Affiliation
MS Ramaiah Memorial Hospital, Bangalore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Care Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
Facility Name
SAL Hospital and Medical Institute
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380054
Country
India
Facility Name
MS Ramaiah Memorial Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Bhagawan Mahaveer Jain Heart Centre
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
5660052
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
25484310
Citation
Chullikana A, Majumdar AS, Gottipamula S, Krishnamurthy S, Kumar AS, Prakash VS, Gupta PK. Randomized, double-blind, phase I/II study of intravenous allogeneic mesenchymal stromal cells in acute myocardial infarction. Cytotherapy. 2015 Mar;17(3):250-61. doi: 10.1016/j.jcyt.2014.10.009. Epub 2014 Dec 4.
Results Reference
derived
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Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI
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