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

Phase 1

• Conditions: Health Condition 1: null- Coronary Artery DiseaseHealth Condition 2: I255- Ischemic cardiomyopathyHealth Condition 3: I214- Non-ST elevation (NSTEMI) myocardial infarction

• Registration Number: CTRI/2009/091/000590
• Lead Sponsor: Frontier Lifeline PvtLtd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 90

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified