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Umbilical Cord Mesenchymal Stem Cells for Patients With Liver Cirrhosis

This study is currently recruiting participants.
Verified August 2012 by Beijing 302 Hospital
Sponsor:
Information provided by (Responsible Party):
Fu-sheng Wang, Beijing 302 Hospital
ClinicalTrials.gov Identifier:
NCT01220492
First received: October 4, 2010
Last updated: August 15, 2012
Last verified: August 2012
History of Changes
  Purpose

Liver cirrhosis (LC) represents a late stage of progressive hepatic fibrosis characterized by distortion of the hepatic architecture and formation of regenerative nodules. The liver transplantation is one of the only effective therapies available to such patients. However, lack of donors, surgical complications, rejection, and high cost are it`s serious problems. The potential for stem cells to differentiate into hepatocytes cells was recently confirmed. Particularly, autologous bone marrow-derived mesenchymal stem cell (BM-MSC) has been demonstrated to decrease MELD score and increase serum albumin in 4 of patients with decompensated liver cirrhosis. Therefore, the investigators propose a hypothesis that umbilical cord-derived MSCs (UC-MSC) can also improve the disease conditions of LC patients, particularly reducing the decompensated conditions in these patients.


Condition Intervention Phase
Liver Cirrhosis
 Drug: conventional plus MSC treatment
Drug: conventional plus placebo treatment
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of UC-MSC Treatment for the Evaluation the Efficacy and Safety in Patients With Liver Cirrhosis

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by Beijing 302 Hospital:

Primary Outcome Measures:
  • ascites volume [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the patient number of liver function worsening [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • the number of patients with ascites after 12-week treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • The levels of serum alanine aminotransferase [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • The levels of serum total bilirubin [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • The levels of INR [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • The levels of serum prothrombin activity [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • liver function evaluation using MELD-Na score model [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • plasma albumin level [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • plasma HBV load [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • complications [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • blood routine examination [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • renal function tests [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: May 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: conventional plus MSC treatment
participants will receive conventional treatment plus a dose of MSC from day 0 through the week 8 study visit. Participants will then be followed until the week 48 study visit.
 Drug: conventional plus MSC treatment
received conventional treatment and taken i.v., once per 4 week, at a dose of 0.5*10E6 MSC/kg body for 8 weeks.
Other Name: conventional plus MSC treatment
Experimental: conventional plus placebo treatment
participants will receive conventional plus placebo treatment from day 0 through the week 8 study visit. Participants will then be followed until the week 48 study visit.
 Drug: conventional plus placebo treatment
received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 8 weeks.
Other Name: conventional plus placebo treatment

Detailed Description:

Liver cirrhosis (LC) represents a late stage of progressive hepatic fibrosis characterized by distortion of the hepatic architecture and formation of regenerative nodules. The liver transplantation is one of the only effective therapies available to such patients. However, lack of donors, surgical complications, rejection, and high cost are it`s serious problems.

The potential for stem cells to differentiate into hepatocytes cells was recently confirmed. In particular, bone marrow-derived mesenchymal stem cell (BM-MSC) transplantation has been applicated in the clinic for treat several human diseases such as GVHD, cardiac injury and brain injury, and displayed good tolerance and efficiency. BM-MSC has also been used to treat human liver diseases such as liver failure and liver cirrhosis. In a phase 1 study, autologous BM-MSC transplantation has potential to decrease MELD score and increase serum albumin in 4 of patients with decompensated liver cirrhosis.

The purpose of this study is to learn whether and how umbilical cord-derived MSCs (UC-MSC) can improve the disease conditions in patients with liver cirrhosis. This study will also look at how well BM-MSC is tolerated and its safety in LC patients.

Participants in the study will be randomly assigned to one of two treatment arms:

Arm A: Participants will receive 8 weeks of conserved treatment plus UC-MSC treatment.

Arm B: Participants will receive 8 weeks of conserved treatment plus saline.

UC-MSC will be prepared according to standard procedures and is collected in plastic bags containing anti coagulant. MSCs are given via i.v. under sonography monitoring. After cell therapy, patients are followed up at week 4, 8, 12, 24, 36 and 48. The evaluation of some clinical parameters such as the level of ascites volume and ascites disappearance rate, serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), the rountin blood test, renal function test are detected at these timepoints. MELD-Na scores and clinical symptoms as well as complication were also observed simultaneously.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Liver cirrhosis
  2. Negative pregnancy test (female patients in fertile age)
  3. written consent

Exclusion Criteria:

  1. Hepatocellular carcinoma or other malignancies
  2. Pregnancy
  3. sepsis
  4. Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
  5. Cardiac, renal or respiratory failure
  6. Active thrombosis of the portal or hepatic veins
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220492

Contacts
Contact: Fu-Sheng Wang, Professor 86-10-63879735 ext 2015.12 fswang@bbn.cn

Locations
China, Beijing
Beijing 302 Hospital Recruiting
Beijing, Beijing, China, 100039
Contact: Zheng Zhang, Doctor     86-10-63879735 ext 2015.12     zhangzheng1975@yahoo.com.cn    
Principal Investigator: Fu-Sheng Wang, Professor            
Sponsors and Collaborators
Beijing 302 Hospital
Investigators
Principal Investigator: Fu-Sheng Wang, Professor Beijing 302 Hospital
  More Information

Publications:

Responsible Party: Fu-sheng Wang, the Institute of Translational hepatology, Beijing 302 Hospital
ClinicalTrials.gov Identifier: NCT01220492     History of Changes
Other Study ID Numbers: beijing302-002
Study First Received: October 4, 2010
Last Updated: August 15, 2012
Health Authority: China: Ministry of Health

Keywords provided by Beijing 302 Hospital:
liver cirrhosis
mesenchymal stem cells
ascites
serum albumin

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013