World Health Organization site
Skip Navigation Links

Main
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 29 June 2014
Main ID:  CTRI/2009/091/000590
Date of registration: 29-01-2010
Primary sponsor: Frontier Lifeline Pvt.Ltd
Public title: Clinical trial to study the safety and efficacy of stem cell therapy in patients with severe ventricular dysfunction
Scientific title: Stem cell therapy- Cellular Cardio myoplasty for patients with severe ventricular dysfunction
Date of first enrolment: 01-04-2010
Target sample size: 150
Recruitment status: Open to Recruitment
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=788
Study type:  Observational
Study design:  Non-randomized, Multiple Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
 
Countries of recruitment
Contacts
Key inclusion & exclusion criteria
Inclusion criteria: Adult males aged between 40 to 60 years presenting with coronary artery disease (CAD) with reversible myocardial ischemia revealed by stress thallium test. Single vessel CAD with left ventricular ejection fraction (LVEF) less than 30% and multivessel CAD with LVEF less than 30% are eligible for enrolement. There should be a minimum of 6 months since last episode of myocardial infarction or minimum of 3 months since initial anginal episode.
Exclusion criteria: 1. Sustained ventricular tachycardia in a 24 hour ECG.
2. Chronic atrial fibrillation.
3. Less than 6 months since last episode of cerebral
infarction.
4. Less than 6 months since last coronary angioplasty or
less than 3 months since last bypass surgery.
5. Patients with unstable angina, with a treatment rating
of 3 in the Braunwald system, but a severity of III and a
clinical rating of B or C.
6. Presence of left ventricular thrombus by
echocardiography.
7. Patient with a malignant tumour.
8. Patient with diabetic proliferating retinopathy** (new
Fukuda classification BI to BV).
9. Patients with chronic rheumatoid arthritis.
10. Patient with haematological disease (leukaemia,
myeloproliferative disease or myelodysplastic
syndromes.
11. Patients for whom cranial MRA reveals cerebral
aneurysm.
12. Patients for whom abdominal CT or ultrasonography
reveals splenomegaly.
13 Patients with cirrhosis of the liver.
14. Patients who cannot discontinue warfarin.
15. AST (GOT) exceeding 100 IU/L or ALT (GPT)
exceeding 100 IU/L.
16. Patients for whom it is impossible to perform both
cardiac MRI and left ventriculography (LVG).
17. Any other reason that the Clinical supervisors or
clinical Researchers may have for considering a case
unsuitable for the study.


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Coronary Artery Disease
Intervention(s)
Intervention1: Stemcell Therapy, CABG: 10ml(each ml = 10 to the power 8 no.of cells)

Control Intervention1: CABG: NIL
Primary Outcome(s)
Increase in myocardial perfusion identified by stress thallium by myocardial scintigraphy. Decrease in areas of infarction by rest thallium. Increase in ejection fraction by Echo teicholz method.Timepoint: 3 months and 6 months
Secondary Outcome(s)
Improvement in regional LV function by evaluation of symptoms using CCSAA and NYHA classification. Improvement in ejection fraction more than 5% in 2D echo and 3D echo and tissue doppler studiesTimepoint: 3 months and 6 months
Secondary ID(s)
CTRI/2009/091/000590
NIL
Source(s) of Monetary Support
Frontier Lifeline Pvt.Ltd
Secondary Sponsor(s)
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.1 - Version history