Alcoholic Liver Cirrhosis Clinical Trial
Official title:
The Evaluation of Effectiveness and Safety for New Therapy With Bone Marrow Derived Autologous Mesenchymal Stem Cell for Hepatic Failure Caused by Alcoholic Liver Cirrhosis
Background & Aim: Bone marrow derived mesenchymal stem cells (BM-MSCs) have capacity to
differentiate into hepatocytes and anti-fibrotic effect in the experimental model. No study
was done in humans with alcoholic liver cirrhosis. The researchers investigated the
anti-fibrotic effect of BM-MSCs in alcoholic cirrhosis as Phase II clinical study.
Methods: Eleven alcoholic cirrhosis patients (M:F = 10:1) with Child-Pugh's class B and
maintenance of alcohol abstinence at least 2 months were enrolled. At baseline, all patients
received liver biopsy, hepatic venous pressure gradient (HVPG) measurement and serologic
tests. BM-MSCs were isolated from each patient's BM and amplified for one month and injected
two times at 4, 8week through Rt. hepatic artery. 5x106cells/mL of BM-MSCs were injected in
each session. Follow up biopsy, HVPG and relative expression of tissue transforming growth
factor-1 (TGF-β1), α smooth muscle actin (α-SMA) and collagen-1 by real time RT PCR were
measured after 12weeks from 2nd BM-MSC injection. The primary outcome was improvement in
patients' histology Aim :
The researchers aimed to evaluate safety and effectiveness of new therapy with bone marrow
derived autologous mesenchymal stem cell for hepatic failure caused by alcoholic liver
cirrhosis.
Autologous BM-MSCs therapy in alcoholic cirrhosis induces improvement of hepatic fibrosis in histological and quantitative measurements. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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