| CTRI Number |
CTRI/2010/091/000626 [Registered on: 10/08/2010] |
| 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
|
Autologous Stem cell Transplantation in Ischaemic Cardiomyopathy with diffuse Coronary Heart Disease. |
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Scientific Title of Study
|
Autologous Stem cell Transplantation in Ischaemic Cardiomyopathy with diffuse Coronary Heart Disease. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.PLN Kaparthi |
| Designation |
|
| Affiliation |
|
| Address |
Global Hospital 6-1-1070/1to 4
Lakdikapul
Hyderabad
ANDHRA PRADESH
500 004
India |
| Phone |
+91 40 23244444 |
| Fax |
+91 40 23233166 |
| Email |
dr.kaparthi@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Lakshmi Kiran |
| Designation |
|
| Affiliation |
Co-Investigator |
| Address |
6-1-1070/1to 4
Lakdikapul
Hyderabad
ANDHRA PRADESH
500 004
India |
| Phone |
+91 40 23244444 |
| Fax |
+91 40 23233166 |
| Email |
apparusu@hotmail.com |
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Details of Contact Person
Public Query
|
| Name |
Dr.Smita Gheyee |
| Designation |
|
| Affiliation |
|
| Address |
6-1-1070/1to 4
Lakdikapul
Hyderabad
ANDHRA PRADESH
500 004
India |
| Phone |
+91 40 23244444 |
| Fax |
+91 40 23233166 |
| Email |
drsmitagheyee@globalhospital.net |
|
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Source of Monetary or Material Support
|
| Global Medical Education & Research Center
M/s G.E. Ravindranath Associates pvt. Ltd.
Lakdikapul
Hyderabad-500 004 (Andhra Pradesh)
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Primary Sponsor
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| Name |
Global Medical Education and research centre |
| 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.Lakshmi Kiran |
Global Hospital |
6-1-1070/1to4,Lakdikapul-500 004
Hyderabad
ANDHRA PRADESH |
+40 30244501
+ 91 40 23233166
lkiran@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 |
Coronary Heart disease, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Autologous MNCs CD-34+AND CD 45+ CELLS |
|
| Comparator Agent |
NIL |
NIL |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
|
| Details |
Ages Eligible for Study: >21 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
External angina class III ? IV.
Severe LV systolic dysfunction with EF ≤ 30%
Single/Multi vessel coronary artery disease with diffuse atherosclerotic disease neither suitable for (CADGS) bypass grafting nor for percutaneous intervention (PTCA + Stenting).
?Hypokinetic, Akinetic, Dyskinetic segments assessed by 16 segments Echo model.
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| ExclusionCriteria |
| Details |
? LVEF ≤ 31%.
? Severe hepatic or renal dysfunction (Co-morbid Medical condition).
? Stroke with significant sequel.
? HIV/HBS/HCV positive serology.
? Short life expectancy due to cancer/ terminal illness which influence the patient.
? Mental disorders.
? Possibility of non-compliance with the protocol.
? Gross CCF/Pulmonary edema.
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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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Blinding/Masking
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Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| ? Improvement in LVEF perfusion measured by ECG, 2D-ECHO, Cardiac MRI Coronary angiography. |
12 months |
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Secondary Outcome
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| Outcome |
TimePoints |
| ? Safety
? Improvement in myocardial function observed in SA node, AV node measured by ECG.
? 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 (Mild to Moderate), (Rest or Minimal to Mild).
? 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
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N/A |
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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) |
17/02/2006 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="4"
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 myocardial ischemia is to induce neovascularization of the heart using ?angiogens? from tissue sources in the formation of blood vessels. Bone marrow isolated autologous 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 isolated autologous 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 diffuse coronary artery disease are screened by SPECT will be subjected to the therapeutic procedure with the intrarterial infusion of bone marrow isolated autologous MNCs (CD-34+ and CD-45+). 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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