| CTRI Number |
CTRI/2009/091/000176 [Registered on: 20/04/2009] |
| Last Modified On: |
28/02/2013 |
| Post Graduate Thesis |
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| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Stem Cell Therapy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
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A controlled study with allogenic mesenchymal stem cells in patients with Myocardial Infarction |
Scientific Title of Study
Modification(s)
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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) |
Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| SRPL/AMI/07-08/001 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
Dr Sudheer Balaraju |
| Designation |
|
| Affiliation |
Manipal Acunova Ltd |
| Address |
Manipal AcuNova Ltd., Mobius Towers, SJR-i-Park
EPIP, Whitefield
Bangalore
KARNATAKA
560066
India |
| Phone |
080-66915700 |
| Fax |
080-66915719 |
| Email |
sudheer.balaraju@ecronacunova.com |
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Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sudheer Balaraju |
| Designation |
|
| Affiliation |
|
| Address |
Manipal AcuNova Ltd., Mobius Towers, SJR-i-Park
EPIP, Whitefield
Bangalore
KARNATAKA
560066
India |
| Phone |
080-66915700 |
| Fax |
080-66915719 |
| Email |
sudheer.balaraju@ecronacunova.com |
|
Source of Monetary or Material Support
Modification(s)
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| Stempeutics Research Pvt. Ltd., Akshay Tech Park
#72 & 73, Second Floor,
EPIP Zone, Phase-I,
Whitefield, Bangalore- 560 066 |
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Primary Sponsor
Modification(s)
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| Name |
Stempeutics Research Pvt Ltd |
| Address |
Akshay Tech Park
#72 & 73, Second Floor,
EPIP Zone, Phase-I,
Whitefield, Bangalore- 560 066 |
| Type of Sponsor |
Research institution |
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Details of Secondary Sponsor
Modification(s)
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|
Countries of Recruitment
Modification(s)
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India |
Sites of Study
Modification(s)
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| No of Sites = 4 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.S.S.Ramesh |
Bhagwan Mahaveer Jain Hospital |
Miller Road,Vasanth Nagar,-560055
Bangalore
KARNATAKA |
080-41999329
080-2226816
ssramesh@vivushealth.net |
| Dr A Sreenivas Kumar |
Care Hospital |
Room No.1,Banjara Hills-500034
Hyderabad
ANDHRA PRADESH |
04030418888
04066625003
arramraj@yahoo.com |
| Dr. Satya Gupta |
Care Institute of Medical Sciences |
Opp. Panchamrut Bunglow, Nr. Shukan Mall,,Off Science City Road, Sola-380060
Ahmadabad
GUJARAT |
+91 9925045780
satya.gupta@heartcareclinic.org |
| Dr. Prakash V.S |
M.S.Ramaiah Hospital & Narayana Hrudayalaya Centre |
MSR Nagar, MSRIT Post,-560034
Bangalore
KARNATAKA |
080-40528411
080-40528402
drprakashvs@gmail.com |
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Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Care Foundation Institutional Ethics Committee |
Approved |
| Ethics Committee of Care Institute of Medical Sciences |
Approved |
| Institutional Review Board, Cardiac Research Academy & Srinivasa Cardiology Centre Pvt Ltd |
Approved |
| M.S.Ramaiah Medical College and Teaching Hospital Ethical Review Board |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
ST elevated acute myocardial infarction (STEMI) |
|
Intervention / Comparator Agent
Modification(s)
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| Type |
Name |
Details |
| Intervention |
Ex vivo cultured adult allogenic MSCs |
Single IV dose of allogenic MSCs (2 million cells per Kg body weight suspended in Plasmalyte-A) infused within a period of 30 to 45 min |
| Comparator Agent |
Plasmalyte-A |
Single IV dose of Plasmalyte-A infused within a period of 30 to 45 min |
|
Inclusion Criteria
Modification(s)
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| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients with STEMI aged between 20 and 70 years, either males or females with non-child bearing potential, after 2 days of successful PCI.
b) Patient has global left ventricular systolic dysfunction with an ejection fraction of
<50% and >30%.
c) 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.
d) The target lesion located in the proximal section of the left anterior descending, left circumflex or right coronary artery.
e) Patient with acute myocardial infarction within 10 days prior to IP administration.
f) Normal liver and renal function.
g) Able to understand study information provided to him.
h) Able to give voluntary written consent. |
|
| ExclusionCriteria |
| Details |
a) History of acute/chronic inflammatory condition or severe aortic stenosis or insufficiency; severe mitral stenosis or severe mitral insufficiency.
b) Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
c) Advanced renal dysfunction and creatinine ≥ 2mg%.
d) Advanced hepatic dysfunction.
e) 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
f) Previous MI.
g) Patients already enrolled in another investigational drug trial.
h) History of severe alcohol or drug abuse within 3 months of screening.
i) Women with child bearing potential or who are pregnant or lactating.
j) Having tested positive for HIV 1, HCV, HBV, syphilis and CMV(IgM).
k) Patients contraindicated for MRI. |
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Method of Generating Random Sequence
Modification(s)
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Computer generated randomization |
Method of Concealment
Modification(s)
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Centralized |
Blinding/Masking
Modification(s)
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Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
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| Outcome |
TimePoints |
The primary safety end points are:
1.The type of AE(s),number of AE(s) and proportion of patients with AE(s)2.Assessment of clinical laboratory parameters
3.Assessment of vital signs
4.Assessment of electrocardiogram (ECG) parameters
The primary efficacy endpoint is:
1.Improvement in left ventricular ejection fraction (LVEF), end systolic volume, and end diastolic volume assessed by echocardiography at the end of 6 months. |
All primary end points are assessed at the end of 6 months. Subjects are followed for safety reasons for uptil 2 years |
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Secondary Outcome
Modification(s)
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| Outcome |
TimePoints |
Secondary outcome variables:
The secondary efficacy endpoints are:
1.Assessment of regional myocardial perfusion by SPECT
2.Assessment of percentage change in infarct size by MRI
3.Assessment of regional myocardial function by MRI |
Assessed at the end of 6months |
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Target Sample Size
Modification(s)
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Total Sample Size="20"
Sample Size from India="20" |
Phase of Trial
Modification(s)
|
Phase 1/ Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
06/05/2009 |
| Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
Brief Summary
Modification(s)
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This study has been designed as a randomized, double blinded, multi centric, 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 STEMI after 2 days of PCI. A total of 20 patients will be recruited in this study based on inclusion/exclusion criteria and will be randomized into either treatment or control group The control group will receive standard protocol of care (POC)* along with Plasmalyte injection (placebo) administered intravenously, whereas the treatment group will receive a single dose of 2 million cells per Kg body weight allogenic MSCs administered intravenously (IV) along with standard POC. Patients will be evaluated at 7 days, 1 month, 3 months and 6 months for safety and efficacy parameters. A clinical study report will be generated and submitted to the regulatory authorities after 6 months. Additional evaluation will be undertaken 1 year and 2 years after the treatment for safety parameters. |