The Effectiveness and Safety for Mesenchymal Stem Cell for Alcoholic Liver Cirrhosis
|ClinicalTrials.gov Identifier: NCT01741090|
Recruitment Status : Unknown
Verified December 2012 by Moon Young Kim, Yonsei University.
Recruitment status was: Recruiting
First Posted : December 4, 2012
Last Update Posted : December 10, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Alcoholic Liver Cirrhosis||Biological: mesenchymal stem cell injection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||August 2013|
Experimental: MSC injection
This study is designed as single interventional arm without comparative arm. MSC injection means hepatic artery catheterizations and mesenchymal stem cell injection through catheter.
Biological: mesenchymal 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.
- The improvement of Liver Histologic grade [ Time Frame: 6 months later ]according to Metavir and Laennec fibrosis scoring system
- 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 [ Time Frame: 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 [ Time Frame: baseline and 6 months later ]
- Hepatic venous pressure gradient(HVPG) [ Time Frame: baseline and 6 months later ]HVPG is a gold standard to measure the portal hypertension.
- Hepatic vein arrival time using microbubble contrast enhanced ultrasonography [ Time Frame: 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.
- Liver stiffness measurement with transient elastography [ Time Frame: 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 [ Time Frame: baseline and 6 months later ]
- MELD score [ Time Frame: baseline and 6 months later ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741090
|Contact: Soon Koo Baik, M.D., PhDfirstname.lastname@example.org|
|Contact: Moon Young Kim, M.D., PhDemail@example.com|
|Korea, Republic of|
|Yonsei University Wonju College of Medicine Wonju Christian Hospital||Recruiting|
|Wonju, Kangwon-do, Korea, Republic of, 220-701|
|Contact: Soon Koo Baik, M.D 82-33-741-1229 firstname.lastname@example.org|
|Contact: Moon Young Kim, M.D 82-33-741-1225 email@example.com|
|Principal Investigator: Soon Koo Baik, M.D|
|Sub-Investigator: Moon Young Kim, M.D|
|Principal Investigator:||Soon Koo Baik, M.D||Yonsei University Wonju College of Medicine Department of Internal Medicine Devision of Gastroenterology and Hepatology|