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

Primary Purpose

Acute-On-Chronic Liver Failure

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
mesenchymal stem cell transplantation or placebo infusion via peripheral vein
Sponsored by
Xijing Hospital of Digestive Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute-On-Chronic Liver Failure focused on measuring Acute-On-Chronic Liver Failure, mesenchymal stem cell,

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Changcun GuoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MSC group

control

Arm Description

mesenchymal stem cell transplantation via peripheral vein: 0.1-1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 1, 2 weeks

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

Outcomes

Primary Outcome Measures

Efficacy: 12 week mortality rate
mortality rate assessed at week 12

Secondary Outcome Measures

Clinical remission rate at week 12
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

Full Information

First Posted
September 10, 2018
Last Updated
September 10, 2018
Sponsor
Xijing Hospital of Digestive Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT03668171
Brief Title
Mesenchymal Stem Cell Transplantation for Acute-on-chronic Liver Failure
Official Title
Mesenchymal Stem Cell Transplantation for Acute-on-chronic Liver Failure, a Randomized, Double Blind, Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital of Digestive Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute-On-Chronic Liver Failure
Keywords
Acute-On-Chronic Liver Failure, mesenchymal stem cell,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomization will be blinded to participant, care provider, investigator and outcome assessors.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MSC group
Arm Type
Experimental
Arm Description
mesenchymal stem cell transplantation via peripheral vein: 0.1-1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 1, 2 weeks
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
mesenchymal stem cell transplantation or placebo infusion via peripheral vein
Intervention Description
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
Primary Outcome Measure Information:
Title
Efficacy: 12 week mortality rate
Description
mortality rate assessed at week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Clinical remission rate at week 12
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Han, MD
Phone
862984771539
Email
guochc@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Changcun Guo
Phone
13991900180
Email
guochc@sina.com
Facility Information:
Facility Name
Changcun Guo
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changcun Guo
Phone
13991900180
Email
guochc@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol, statistical analysis processes and clinical data of individual participants will be shared.
IPD Sharing Time Frame
within 12 months after the study completion and before publications of the findings.

Learn more about this trial

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

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