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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Hepatic artery catheterization and mesenchymal stem cell injection will be used in alcoholic liver cirrhosis. And before and 1 month after injection, change of liver cirrhosis and portal hypertension will be evaluated.
Yonsei University Wonju College of Medicine Wonju Christian Hospital
Wŏnju, Gangwon-do, South Korea
RECRUITINGThe improvement of Liver Histologic grade
according to Metavir and Laennec fibrosis scoring system
Time frame: 6 months later
The evaluation of hepatic dendritic cells activity by immunohistochemistry
Time frame: baseline and 6 months later
Liver fibrosis quantitative analysis using Hydroxyproline contents in liver tissue
Hydroxyproline is a essential component of collange fiber
Time frame: baseline and 6 months later
Real-Time Polymerase Chain Reaction for relative mRNA expression of TGF-beta, collagen, procollagen, MMP2 or 9
Time frame: baseline and 6 months later
Hepatic venous pressure gradient(HVPG)
HVPG is a gold standard to measure the portal hypertension.
Time frame: baseline and 6 months later
Hepatic vein arrival time using microbubble contrast enhanced ultrasonography
Hepatic vein arrival time is related with portal hypertension and intrahepatic inflammation, neoangiogenesis and shunts formation secondary to hepatic fibrosis.
Time frame: baseline and 6 months later
Liver stiffness measurement with transient elastography
Recently, hepatic fibrosis can be estimated non-invasively using transient elastography (Fibroscan, commercial name) and it can be additive data in estimation of therapeutic response.
Time frame: baseline and 6 months later
Child-Pugh score
Time frame: baseline and 6 months later
MELD score
Time frame: baseline and 6 months later
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