Dose Finding Study to Assess Safety and Efficacy of Stem Cells in Liver Cirrhosis

A Parallel Group Randomized Open Blinded End Point Evaluation, Multicentric, Dose Escalation, Phase -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

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01591200

Enrollment

Registered

2012-05-03

Start date

2012-06-30

Completion date

2016-04-30

Last updated

2016-09-15

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

Conditions

Alcoholic Liver Cirrhosis

Keywords

Alcoholic, Liver, Cirrhosis, Stem, Cells

Brief summary

This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in various parameters will be observed over 2 years.

Interventions

BIOLOGICALAllogeneic Mesenchymal Stem Cells

High dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Alcoholic cirrhotics between 18-65 years of age (diagnosed by clinical, biochemical, sonographic, radiological \[CT scan\] or histological evidence of cirrhosis and portal hypertension). * Evidence of decompensated liver disease at screening (e.g. Child class B or C, Child-Pugh scores of ≥7 and \<14). * MELD scores of at least 10 (UNOS Meld calculator). * Normal AFP Level * Hb\>10gm/dl. * Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study * Signed informed consent.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Safety	2 years	The type of adverse events, number of adverse events and proportion of patients with adverse events

Secondary

Measure	Time frame	Description
CT scan of abdomen.	2 years	To assess the improvement in liver structure
Change in MELD score	2 years	To assess the clinical improvement
Liver function tests.	2 years	To assess the improvement in liver function
Histological evaluation of liver biopsy by immunohistochemical staining for AFP, PCNA, SMA	6 Months	To assess the improvement in histopathology
Change in Child-Pugh score	2 years	To assess clinical improvement
Improvement in quality of life as assessed by SF 36 questionnaire	2 years	To assess the improvement in quality of life

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026