A clinical trial to study the safety and efficacy of stem cells in alcoholic liver cirrhosis

A parallel group randomized open blinded end point evaluation, multicentric, dose escalation, phase â??II study assessing the safety and efficacy of intraarterial (hepatic) ex-vivo cultured adult allogenic mesenchymal stem cells in patients with alcoholic liver cirrhosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/04/002560

Enrollment

Registered

2012-04-10

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

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

Conditions

Health Condition 1: null- Alcoholic liver cirrhosis Health Condition 2: K709- Alcoholic liver disease, unspecified

Interventions

Intervention1: Allogeneic mesenchymal stem cells - low dose: Bone marrow derived mesenchymal stem cells derived from healthy human volunteers will be administered through hepatic artery, in a volume o

Eligibility

Inclusion criteria

Inclusion criteria: 1. Alcoholic cirrhotics between 18-65 years of age (diagnosed by clinical, biochemical, sonographic, radiological [CT scan] or histological evidence of cirrhosis and portal hypertension). 2. Evidence of decompensated liver disease at screening (e.g. Child class B or C, Child-Pugh scores of >=7 and 3. MELD scores of at least 10 (UNOS Meld calculator). 4. Normal AFP Level 5. Hb >10gm/dl. 6. Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study 7. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients likely to undergo liver transplantation during the duration of the study. 2. Presence of advanced hepatic encephalopathy Grades 3 & 4 (West Haven criteria for grading of hepatic encephalopathy) at the time of screening 3. Active variceal bleed. 4. Refractory ascites. 5. Evidences of autoimmune liver disease- ANA or Anti-LKM positivity. 6. Platelet count 30,000/mm3. 7. Serum Sodium 129mEq/L. 8. Serum Creatinine 2 mg/dl. 9. Hepatocellular carcinoma or other malignancies 10. Active infectious disease. 11. Presence of severe underlying cardiac, pulmonary or renal disease. 12. Excessive alcohol (30 gm of alcohol/day) use in the last 3 months before screening. 13. Positive HbSAg or antibodies to HIV or HCV. 14. Pregnancy or lactation. 15. Participation in other clinical trials. 16. Unwilling/unable to sign the informed consent.

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability following a single dose of allogeneic mesenchymal stem cells administered via the percutaneous puncture of the femoral artery followed by selective cannulation of the hepatic artery (Seldinger Technique) in Alcoholic Liver Cirrhosis patientsTimepoint: 2 years	—

Secondary

Measure	Time frame
To assess the potential of allogeneic mesenchymal stem cells to improve the liver function and quality of life in Alcoholic Liver Cirrhosis patientsTimepoint: 2years;To find the suitable dose of allogeneic mesenchymal stem cells to improve the liver function and quality of life in Alcoholic Liver Cirrhosis patientsTimepoint: 2years	—

Countries

India

Contacts

Public ContactJijy Abraham

Stempeutics Research Pvt. Ltd.

anoop.ch@stempeutics.com080-39992400

Outcome results

None listed

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