Alcoholic Liver Cirrhosis
Conditions
Keywords
Autologous Mesenchymal stem cell, alcoholic liver cirrhosis
Brief summary
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.
Detailed description
Autologous BM-MSCs therapy in alcoholic cirrhosis induces improvement of hepatic fibrosis in histological and quantitative measurements.
Interventions
BIOLOGICALmesenchymal stem cell injection
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.
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Alcoholic liver cirrhosis(child Pugh class B or C, ≥ 7 scores),confirmed by clinically or biopsy. 2. Stop drinking over past 6months. 3. Patients agree with informed consent Patients must satisfy all inclusion criteria.
Exclusion criteria
1. Patients who did not satisfy inclusion criteria 2. Hepatocellular carcinoma 3. Pregnancy or breast feeding 4. Infective disease(HIV, HBV, HCV..) 5. Other incurable malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The improvement of Liver Histologic grade | 6 months later | according to Metavir and Laennec fibrosis scoring system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver fibrosis quantitative analysis using Hydroxyproline contents in liver tissue | baseline and 6 months later | Hydroxyproline is a essential component of collange fiber |
| Real-Time Polymerase Chain Reaction for relative mRNA expression of TGF-beta, collagen, procollagen, MMP2 or 9 | baseline and 6 months later | — |
| Hepatic venous pressure gradient(HVPG) | baseline and 6 months later | HVPG is a gold standard to measure the portal hypertension. |
| The evaluation of hepatic dendritic cells activity by immunohistochemistry | baseline and 6 months later | — |
| Liver stiffness measurement with transient elastography | baseline and 6 months later | 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. |
| Child-Pugh score | baseline and 6 months later | — |
| MELD score | baseline and 6 months later | — |
| Hepatic vein arrival time using microbubble contrast enhanced ultrasonography | baseline and 6 months later | Hepatic vein arrival time is related with portal hypertension and intrahepatic inflammation, neoangiogenesis and shunts formation secondary to hepatic fibrosis. |
Countries
South Korea
Contacts
Primary ContactSoon Koo Baik, M.D., PhD
Backup ContactMoon Young Kim, M.D., PhD
Outcome results
None listed