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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2009/091/000590
• Date of registration: 29-01-2010
• Prospective Registration: Yes
• Primary sponsor: Frontier Lifeline PvtLtd
• 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: 90
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=788
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
• Phase: Phase 1/ Phase 2

Countries of recruitment

India

Contacts

• Name: Dr Rajaram Anantharaman
• Affiliation: Frontier Lifeline Pvt.Ltd

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

Key inclusion & exclusion criteria

Inclusion criteria: Patients aged between 0 to 60 years presenting with Dilated Cardiomyopathy or coronary artery disease (CAD) are enrolled. Patients with ventricular ejection fraction (LVEF) less than 35% are eligible for enrollement.
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

Health Condition 1: null- Coronary Artery Disease Health Condition 2: I255- Ischemic cardiomyopathy Health Condition 3: I214- Non-ST elevation (NSTEMI) myocardial infarction

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 NYHA and increase in ejection fraction by Echo teicholz method.Timepoint: one year as per patients availability for follow up.

Secondary ID(s)

NIL

CTRI/2009/091/000590

Source(s) of Monetary Support

Frontier Lifeline Pvt.Ltd

Ethics review

Status: Approved
Approval date: 20/04/2013
Contact:

Institutional Ethics Committee

Status: Approved
Approval date: 23/02/2015
Contact:

IC SCR