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Alcoholic Liver CirrhosisPhase 2NCT01741090

The Effectiveness and Safety for Mesenchymal Stem Cell for Alcoholic Liver Cirrhosis

A Phase 2 study testing mesenchymal stem cell injection in people with Alcoholic Liver Cirrhosis, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Alcoholic Liver Cirrhosis
What is being tested?
mesenchymal stem cell injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSouth Korea
Study dates
Sep 2009to Aug 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Alcoholic liver cirrhosis(child Pugh class B or C, ≥ 7 scores),confirmed by clinically or biopsy.
  • Stop drinking over past 6months.
  • Patients agree with informed consent Patients must satisfy all inclusion criteria.

Who cannot join

  • Patients who did not satisfy inclusion criteria
  • Hepatocellular carcinoma
  • Pregnancy or breast feeding
  • Infective disease(HIV, HBV, HCV..)
  • Other incurable malignancy

Trial locations and contacts

1 site in 1 country.

Soon Koo Baik, M.D., PhD contact

82-33-741-1229

baiksk@medimail.co.kr

Moon Young Kim, M.D., PhD contact

82-33-741-1225

drkimmy@yonsei.ac.kr

South Korea1 site, 1 recruiting

  • Yonsei University Wonju College of Medicine Wonju Christian Hospital

    Wŏnju, Gangwon-do, 220-701

    Soon Koo Baik, M.D, 82-33-741-1229, baiksk@medimail.co.kr

    Moon Young Kim, M.D, 82-33-741-1225, drkimmy@yonsei.ac.kr

    Recruiting

Other trials in South Korea

About this study

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.

Read the detailed description

Autologous BM-MSCs therapy in alcoholic cirrhosis induces improvement of hepatic fibrosis in histological and quantitative measurements.

Being tested
mesenchymal stem cell injection
Keywords
Autologous Mesenchymal stem cell, alcoholic liver cirrhosis
Medical subject headings
Liver Cirrhosis, Alcoholic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mesenchymal stem cell injectionBiological

    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.

Study groups in NCT01741090
Study groupRoleWhat they receive
MSC injectionExperimentalThis study is designed as single interventional arm without comparative arm. MSC injection means hepatic artery catheterizations and mesenchymal stem cell injection through catheter.
Receives: Biological: mesenchymal stem cell injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The improvement of Liver Histologic grade

    according to Metavir and Laennec fibrosis scoring system

    Measured: 6 months later

Secondary outcomes (8)

  1. The evaluation of hepatic dendritic cells activity by immunohistochemistry

    Measured: baseline and 6 months later

  2. Liver fibrosis quantitative analysis using Hydroxyproline contents in liver tissue

    Hydroxyproline is a essential component of collange fiber

    Measured: baseline and 6 months later

  3. Real-Time Polymerase Chain Reaction for relative mRNA expression of TGF-beta, collagen, procollagen, MMP2 or 9

    Measured: baseline and 6 months later

  4. Hepatic venous pressure gradient(HVPG)

    HVPG is a gold standard to measure the portal hypertension.

    Measured: baseline and 6 months later

  5. 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.

    Measured: baseline and 6 months later

  6. 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.

    Measured: baseline and 6 months later

  7. Child-Pugh score

    Measured: baseline and 6 months later

  8. MELD score

    Measured: baseline and 6 months later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2012 (estimated)
  2. Study startSep 2009
  3. Primary completionJun 2013 (estimated)
  4. Study completionAug 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01741090
Sponsor's protocol ID
CR109021
Status last verified
Dec 2012
First submitted
10 Nov 2011
Last updated
10 Dec 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Kountouras J, Billing BH, Scheuer PJ. Prolonged bile duct obstruction: a new experimental model for cirrhosis in the rat. Br J Exp Pathol. 1984 Jun;65(3):305-11.

    PubMed 6743531

  • Batts KP, Ludwig J. Chronic hepatitis. An update on terminology and reporting. Am J Surg Pathol. 1995 Dec;19(12):1409-17. doi: 10.1097/00000478-199512000-00007.

    PubMed 7503362

  • Hong SH, Gang EJ, Jeong JA, Ahn C, Hwang SH, Yang IH, Park HK, Han H, Kim H. In vitro differentiation of human umbilical cord blood-derived mesenchymal stem cells into hepatocyte-like cells. Biochem Biophys Res Commun. 2005 May 20;330(4):1153-61. doi: 10.1016/j.bbrc.2005.03.086.

    PubMed 15823564

  • Lee KD, Kuo TK, Whang-Peng J, Chung YF, Lin CT, Chou SH, Chen JR, Chen YP, Lee OK. In vitro hepatic differentiation of human mesenchymal stem cells. Hepatology. 2004 Dec;40(6):1275-84. doi: 10.1002/hep.20469.

    PubMed 15562440

  • Kang XQ, Zang WJ, Bao LJ, Li DL, Song TS, Xu XL, Yu XJ. Fibroblast growth factor-4 and hepatocyte growth factor induce differentiation of human umbilical cord blood-derived mesenchymal stem cells into hepatocytes. World J Gastroenterol. 2005 Dec 21;11(47):7461-5. doi: 10.3748/wjg.v11.i47.7461.

    PubMed 16437717

  • Kallis YN, Alison MR, Forbes SJ. Bone marrow stem cells and liver disease. Gut. 2007 May;56(5):716-24. doi: 10.1136/gut.2006.098442. Epub 2006 Dec 4. No abstract available.

    PubMed 17145739

  • Wang JA, Luo RH, Zhang X, Xie XJ, Hu XY, He AN, Chen J, Li JH. Bone marrow mesenchymal stem cell transplantation combined with perindopril treatment attenuates infarction remodelling in a rat model of acute myocardial infarction. J Zhejiang Univ Sci B. 2006 Aug;7(8):641-7. doi: 10.1631/jzus.2006.B0641.

    PubMed 16845718

  • Kim MY, Cho MY, Baik SK, Park HJ, Jeon HK, Im CK, Won CS, Kim JW, Kim HS, Kwon SO, Eom MS, Cha SH, Kim YJ, Chang SJ, Lee SS. Histological subclassification of cirrhosis using the Laennec fibrosis scoring system correlates with clinical stage and grade of portal hypertension. J Hepatol. 2011 Nov;55(5):1004-9. doi: 10.1016/j.jhep.2011.02.012. Epub 2011 Feb 24.

    PubMed 21354227

  • Jang YO, Kim YJ, Baik SK, Kim MY, Eom YW, Cho MY, Park HJ, Park SY, Kim BR, Kim JW, Soo Kim H, Kwon SO, Choi EH, Kim YM. Histological improvement following administration of autologous bone marrow-derived mesenchymal stem cells for alcoholic cirrhosis: a pilot study. Liver Int. 2014 Jan;34(1):33-41. doi: 10.1111/liv.12218. Epub 2013 Jun 19.

    PubMed 23782511

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing mesenchymal stem cell injection in people with Alcoholic Liver Cirrhosis, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Soon Koo Baik, M.D., PhD (82-33-741-1229, baiksk@medimail.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The improvement of Liver Histologic grade (time frame: 6 months later). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01741090, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2012.

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