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

Stem cell therapy- Cellular Cardio myoplasty for patients with severe ventricular dysfunction

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000590

Enrollment

Registered

2010-01-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Stemcell Therapy, CABG: 10ml(each ml = 10 to the power 8 no.of cells) Control Intervention1: CABG: NIL

Eligibility

Inclusion 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

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.

Design outcomes

Primary

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

Countries

India

Contacts

Public ContactDrUsha Raghavan Subramanyan

Frontier Lifeline Pvt.Ltd

ananthdevi@hotmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026