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Mesenchymal Stem Cells Treatment for Decompensated 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03945487
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Fu-Sheng Wang, Beijing 302 Hospital

Study Description
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Brief Summary:
Decompensated liver cirrhosis is a life-threatening chronic liver disease with high mortality. Liver transplantation is the only option that can improve the survival of these patients; however, this procedure is associated with several limitations, such as the severe shortage of donor livers, long waiting lists, multiple complications, and high cost. Our and other previous studies have demonstrated that marrow bone-derived mesenchymal stem cells (BM-MSC) or unbilical cord derived MSC (UC-MSC) infusion is clinically safe and could improve liver function in patients with decompensated liver cirrhosis. However, the long-term outcomes of MSC infusion have not been reported until now. This prospective and randomized controlled study examined the longer-term safety and efficacy of UC-MSC in patients with decompensated liver cirrhosis.

Condition or disease Intervention/treatment Phase
Decompensated Liver Cirrhosis Biological: umbilical cord-derived mesenchymal stem cell Other: Comprehensive treatment Phase 2

Detailed Description:

Liver cirrhosis represents a late stage of progressive hepatic fibrosis characterized by the formation and accumulation of an extracellular matrix, which leads to the progressive distortion of the hepatic architecture. In China, the most important cause of liver cirrhosis is chronic hepatitis B virus (HBV) infection. Liver cirrhosis usually progresses irreversibly into advanced stage, such as a decompensated stage which is characterized by a series of clinical manifestations, including ascites, variceal hemorrhage, and hepatic encephalopathy with high mortality. Liver transplantation is the only option that can improve the survival of these decompensated liver cirrhosis patients; however, this procedure is associated with several limitations, such as the severe shortage of donor livers, long waiting lists, multiple complications, and high cost. Therefore, it is urgent to find a safe and effective therapeutic approach to decompensated liver cirrhosis.

Animal models have shown that bone marrow-derived MSC (BM-MSC) can ameliorate liver fibrosis and reverse fulminant hepatic failure. In clinical, autologous BM-MSC have significantly improved liver function in patients with liver cirrhosis. A recent research also found that autologous BM-MSC therapy safely improved histological fibrosis and liver function in patients with alcoholic cirrhosis. Allogeneic MSC therapy, such as umbilical cord-derived MSC (UC-MSC), have shown to be safe and beneficial for the patients with liver cirrhosis caused by autoimmune diseases. Our previous studies showed that infusions of UC-MSC significantly improved liver function in decompensated liver cirrhosis and primary biliary cirrhosis (PBC) patients and increased the survival rate in acute-on-chronic liver failure (ACLF) patients. However, the single-center clinical study, the relative small size of the patient cohorts, absence of evaluation on long-term efficacy prevent firm conclusions being made with regard to the safety and efficacy of this treatment in liver diseases.

The purpose of this study is to investigate whether and how UC-MSC can improve the liver function, and the incidence of serious complications in patients with decompensated liver cirrhosis through a multi-center clinical study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Human Unbilical Cord Derived-mesenchymal Stem Cells Treatment for Patients With Decompensated Liver Cirrhosis
Estimated Study Start Date : May 20, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Comprehensive treatment plus UC-MSC treatment Biological: umbilical cord-derived mesenchymal stem cell
Taken a dose of 1.0*10E6 UC-MSC/kg body weight intravenously three times at 3-week intervals, in addition to comprehensive treatment.
Comprehensive treatment Other: Comprehensive treatment
  1. All patients received anti-HBV treatment with NAs (entecavir (ETV), tenofovir disoproxil fumarate (TDF), or tenofovir alafenamide (TAF)).
  2. Strategies based on targeting abnormalities in gut-liver axis by antibiotic administration (i.e. rifaximin), improving the disturbed systemic circulatory function (i.e. longterm albumin administration), decreasing the inflammatory state (i.e. statins), and reducing portal hypertension (i.e. beta-blockers).


Outcome Measures
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Primary Outcome Measures :
  1. Liver function [ Time Frame: 96 weeks ]
    including the levels of albumin [ALB], prothrombin activity [PTA], total bilirubin [TBIL, and cholinesterase [CHE].

  2. The incidence of serious complications [ Time Frame: 96 weeks ]
    including infection, gastrointestinal bleeding, encephalopathy, and hepatorenal syndrome.


Secondary Outcome Measures :
  1. The incidence of adverse events [ Time Frame: 96 weeks ]
    e.g. fever, allergy, rash, infection

  2. Disease-free survival time [ Time Frame: 96 weeks ]
    The length of survival time after first UC-MSC treatment for the patient during the follow-up period.

  3. Incidence of hepatocellular carcinoma (HCC) events [ Time Frame: 96 weeks ]
    HCC deveopled in the patient during the follow-up period.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-69 years;
  2. Decompensated liver cirrhosis (manifestations including gastrointestinal bleeding, hepatic encephalopathy, and ascites, based on previously stable cirrhosis);
  3. Positive testing for serum hepatitis B surface antigen (HBsAg) for more than 6 months (chronic hepatitis B patients);
  4. Written consent.

Exclusion Criteria:

  1. Hepatocellular carcinoma or other malignancies;
  2. Liver cirrhosis caused by other reasons, such as autoimmune diseases, alcocal, drugs and so on;
  3. Pregnant women;
  4. The presence of other vital organ severe dysfunction;
  5. Participate in other studies;
  6. Lack of a supportive family;
  7. Refusal to sign the informed consent form.
Contacts and Locations
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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): NCT03945487


Contacts
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Contact: Ming Shi 86-10-63879735 shiming302@sina.com

Locations
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China
Beijing 302 Hospital Recruiting
Beijing, China, 100039
Contact: Ming Shi         
Sponsors and Collaborators
Beijing 302 Hospital
Investigators
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Study Chair: Fu-Sheng Wang Beijing 302 Hospital
More Information
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Responsible Party: Fu-Sheng Wang, Treatment and Research Center for Infectious Diseases, Beijing 302 Hospital
ClinicalTrials.gov Identifier: NCT03945487    
Other Study ID Numbers: Beijing302-011
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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