| CTRI Number |
CTRI/2010/091/000644 [Registered on: 08/07/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Single Arm Study |
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Public Title of Study
|
Functional Restoration of Infracted/ Scarred Myocardium Through Transplantation of Bone Marrow Stem Cells: A Clinical Trial |
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Scientific Title of Study
|
Functional Restoration of Infracted/ Scarred Myocardium Through Transplantation of Bone Marrow Stem Cells: A Clinical Trial |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.A.G.K. Gokhale |
| Designation |
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| Affiliation |
|
| Address |
Global Hospital 6-1-1070/1 to 4
Lakdikapul
Hyderabad
ANDHRA PRADESH
500 004
India |
| Phone |
+91 30244501 |
| Fax |
+91 40 23233166 |
| Email |
allagokhale@hotmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr.Lakshmi Kiran |
| Designation |
|
| Affiliation |
INVESTIGATOR |
| Address |
6-1-1070/1 to 4
Lakdikapul
Hyderabad
ANDHRA PRADESH
500 004
India |
| Phone |
+91 30244501 |
| Fax |
+91 40 23233166 |
| Email |
lkiran@globalhospital.net |
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Details of Contact Person
Public Query
|
| Name |
Dr.Lakshmi Kiran |
| Designation |
|
| Affiliation |
|
| Address |
6-1-1070/1 to 4
Lakdikapul
Hyderabad
ANDHRA PRADESH
500 004
India |
| Phone |
+91 30244501 |
| Fax |
+91 40 23233166 |
| Email |
lkiran@globalhospital.net |
|
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Source of Monetary or Material Support
|
| Global Medical Education and Research Center
M/S. G.E. Ravindranath Associates PVT.Ltd.
Lakdikapool
Hyderabad=500004 (A.P.) |
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Primary Sponsor
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| Name |
Global Medical Education and Research Center |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Smita Gheyee |
Global Hospital |
6-1-1070/1-4,Lakdikapul-500 004
Hyderabad
ANDHRA PRADESH |
+91 40 30242405
+91 40 23233166
drsmitagheyee@globalhospital.net |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Global IEC |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Myocardial Infarction, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
autologus MNCs |
|
| Comparator Agent |
NIL |
NA |
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Ages Eligible for Study: >21 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
?Established cases of MI with ventricular dysfunction graded.
?No other associated primary disorder such as pulmonary hypertension.
?No associated hematological/infectious diseases.
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| ExclusionCriteria |
| Details |
? Not willing to participate.
? No informed consent
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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On-site computer system |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
| ? Improvement in myocardial function observed in SA node, AV node measured by ECG. |
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Secondary Outcome
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| Outcome |
TimePoints |
| ? Safety
? Improvement in LVEF perfusion measured by ECG, 2D-ECHO, Cardiac MRI, Coronary angiography.
? Improved exercise time when observed on the 3rd and 6th month after the therapeutic procedure, when compare to exercise time before the administration of the therapeutic dose.
? Improvement in physical activity.
? Reduction in the use of medicines.
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12 months. |
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Target Sample Size
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Total Sample Size="50"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 1 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/02/2007 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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A new experimental strategy for treating patients with myocardial ischemia and left ventricular dysfunction. Regeneration of the myocardium in damaged regions of the myocardial tissue by using ?cardiomyogens? from tissue sources in the formation of cardimyocytes. Bone marrow derived MNCs (CD-34+ and CD-45+ Cells) are used in the therapeutic process.
The main aim of this study to perform phase I clinical trial with safety and efficacy and also to evaluate the effect of bone marrow derived MNCs (CD-34+ and CD-45+ Cells) as a clinical therapeutic application in the treatment of ischemic heart disease with diffuse CAD.
50 patients with ischemic heart disease with myocardial ischemia and left ventricular dysfunction are screened by SPECT will be subjected to the therapeutic procedure with the direct myocardial injection of autologous bone marrow derived stromal cells (CD-34+ and CD-45+ Cells). Patient monitoring and evaluation is performed for a follow up period of 12 months, in order to identify the effect of the applied clinical therapeutic procedure.
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