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Umbilical Cord Mesenchymal Stem Cells for Patients With Liver Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01220492
Recruitment Status : Completed
First Posted : October 14, 2010
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Fu-Sheng Wang, Beijing 302 Hospital

Brief Summary:
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 the 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 or disease Intervention/treatment Phase
Liver Cirrhosis Drug: conventional plus MSC treatment Drug: conventional plus placebo treatment Phase 1 Phase 2

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 the 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 longer term survival 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 conserved treatment plus three times UC-MSC treatment at 4-week intervals.

Arm B: Participants will receive conserved treatment plus three times saline infusions at 4-week intervals.

UC-MSC will be prepared according to standard procedures and is collected in plastic bags containing anti coagulant. MSCs are infused intravenously. After cell therapy, patients are followed up for 75 months. The evaluation of some clinical parameters such as the level of serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), the rountin blood test are detected at week 12, 24, 48 timepoints. Clinical symptoms as well as complication were also observed simultaneously.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : May 2009
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
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 75 months 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.

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 75 months 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.




Primary Outcome Measures :
  1. survival time [ Time Frame: 75 months ]
  2. incidence of HCC events [ Time Frame: 75 months ]

Secondary Outcome Measures :
  1. The levels of serum albumin [ Time Frame: 48 weeks ]
  2. The levels of serum total bilirubin [ Time Frame: 48 weeks ]
  3. The levels of serum prothrombin activity [ Time Frame: 48 weeks ]
  4. the levels of serum cholinesterase [ Time Frame: 48 weeks ]
  5. complications [ Time Frame: 48 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220492


Locations
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China, Beijing
Beijing 302 Hospital
Beijing, Beijing, China, 100039
Sponsors and Collaborators
Beijing 302 Hospital
Investigators
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Principal Investigator: Fu-Sheng Wang, Professor Beijing 302 Hospital

Publications of Results:
Other Publications:
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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
First Posted: October 14, 2010    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fu-Sheng Wang, Beijing 302 Hospital:
liver cirrhosis
mesenchymal stem cells
longer term survival
safety

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