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Mesenchymal Stem Cell Transplantation for Acute-on-chronic Liver Failure

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: NCT03668171
Recruitment Status : Unknown
Verified September 2018 by Han Ying, Xijing Hospital of Digestive Diseases.
Recruitment status was:  Recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Han Ying, Xijing Hospital of Digestive Diseases

Study Description
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Brief Summary:
Mesenchymal stem cells (MSC) has been reported to improved outcomes of acute-on-chronic liver failure(ACLF). More randomization controlled studies are needed to confirm the effect of MSC treatment for ACLF. This study aimed to investigate the efficacy of mesenchymal stem cells in ACLF patients. This study is an double-blind multicenter randomized and placebo-controlled study. Patients with with ACLF will be randomly assigned to receive MSC treatment (experimental) or standard medical treatment (control). Three times of MSC infusion (0.1-1x10E6cells/kg body weight) via peripheral vein will be given to the experimental group (once per week). The primary outcome is 12 week mortality. Secondary outcomes are clinical remission rate and changes of liver function indices and liver function scores.

Condition or disease Intervention/treatment Phase
Acute-On-Chronic Liver Failure Procedure: mesenchymal stem cell transplantation or placebo infusion via peripheral vein Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Randomization will be blinded to participant, care provider, investigator and outcome assessors.
Primary Purpose: Treatment
Official Title: Mesenchymal Stem Cell Transplantation for Acute-on-chronic Liver Failure, a Randomized, Double Blind, Placebo Controlled Trial
Actual Study Start Date : December 10, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MSC group
mesenchymal stem cell transplantation via peripheral vein: 0.1-1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 1, 2 weeks
 Procedure: mesenchymal stem cell transplantation or placebo infusion via peripheral vein
0.1-1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8 mesenchymal stem cell mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China For control group, placebo infusions will be given to the participants at the same time points
Placebo Comparator: control
placebo infusions (placebo infusion differs from the experimental infusion in only that placebo has no mesenchymal stem cells) will be administered via peripheral vein at week 0, 1, 2
 Procedure: mesenchymal stem cell transplantation or placebo infusion via peripheral vein
0.1-1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8 mesenchymal stem cell mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China For control group, placebo infusions will be given to the participants at the same time points


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy: 12 week mortality rate [ Time Frame: 12 weeks ]
    mortality rate assessed at week 12


Secondary Outcome Measures :
  1. Clinical remission rate at week 12 [ Time Frame: 12 weeks ]
    Clinical remission define as: significant improvement of symptoms and resolution of hepatoencephalopathy; TBIL decrease to below 5 times of ULN，PTA>40% or INR<1.6


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18-70 years old
  • Meeting the criteria of ACLF defined as: 1. definitive chronic liver diseases, acute decompensation within 4 weeks; 2. Significant GI symptom as such fatigue, jaundice,; 3. total bilirubin (TBIL) ≥170 µmo1/L or daily increase of TBIL ≥17.1 µmo1/L; 4. PTA≤40% or INR≥ 1.5; 5. Decompensation of liver functions such as ascites or hepatoencephalopathy;
  • MELD score between 17-30. (MELD(i) = 0.957 × ln(Cr) + 0.378 × ln(bilirubin) + 1.120 × ln(INR) + 0.643)
  • Chronic liver disease with definitive etiology such as viral hepatitis, alcohol liver disease, drug induced liver injury or autoimmune liver diseases
  • Informed consent

Exclusion Criteria:

  • Sever complications with 30 days ( GI bleeding, severe infection)；

    --liver cancer or other malignancies

  • patients on liver transplantation list
  • patients with uncontrolled infections
  • severe renal failure
  • Severe chronic obstructive pulmonary disease COPD (GOLD III-IV)
  • Extrahepatic cholanstasis patients due to biliary obstruction.
  • HIV infection
  • Pregnant or breast-feeding females.
  • Enrolled in other clinical trials with 3 months
  • other conditions considered inappropriate for the study
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): NCT03668171


Contacts
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Contact: Ying Han, MD 862984771539 guochc@fmmu.edu.cn
Contact: Changcun Guo 13991900180 guochc@sina.com

Locations
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China, Shaanxi
Changcun Guo Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Changcun Guo    13991900180    guochc@sina.com   
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
More Information
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Responsible Party: Han Ying, Prof. Dr., Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT03668171    
Other Study ID Numbers: KY20172049-1
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study protocol, statistical analysis processes and clinical data of individual participants will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: within 12 months after the study completion and before publications of the findings.

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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 Han Ying, Xijing Hospital of Digestive Diseases:
Acute-On-Chronic Liver Failure, mesenchymal stem cell,
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
 Liver Diseases
Digestive System Diseases
Liver Failure, Acute