Clinical trial to study the safety and efficacy of stem cell therapy in patients with severe ventricular dysfunction

• Register: CTRI
• Last refreshed on: 4 May 2013
• 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

India

Contacts

• Name: DrAGNarayanasamy
• Affiliation: Frontier Lifeline Pvt.Ltd

• Name: DrUsha Raghavan Subramanyan
• Affiliation: Frontier Lifeline Pvt.Ltd

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 myocardial scintigraphyTimepoint: 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