Back to resultsUC-MSC Infusion for HBV-Related Acute-on-Chronic Liver Failure
Primary Purpose
Liver Failure
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
umbilical cord blood mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Liver Failure
Eligibility Criteria
Inclusion Criteria:
- Patients with ACLF-which is characterized by acute hepatic insult manifesting as jaundice (serum total bilirubin ≥ 10×ULN umol/L) and coagulopathy (international normalized ratio≥ 1.5 or prothrombin activity < 40%), complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination, in patients with previously diagnosed or undiagnosed chronic liver disease;
- Positive serum hepatitis B surface antigen (HBsAg) for more than 6 months;
- End-stage liver disease scores ranging from 17-30,; 4.18-65 years of age.
Exclusion Criteria:
- Serious complications within the previous 2 months (e.g. gastrointestinal bleeding, serious infection );
- Concomitant autoimmune disease;
- Superinfection with other hepatitis viruses;
- Important organ dysfunctions not due to liver disease or malignancies;
- Pregnancy and lactation;
- Liver tumor or nodules secondary to cirrhosis proven by ultrasound, computerized tomography (CT), or magnetic resonance (MR) imaging;
- Bioartificial liver support therapy;
- Previous liver transplantation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Group MSC-1
Group MSC-2
Group Control
Arm Description
Patients in Group MSC-1 received standard medical treatment and infusions of umbilical cord blood mesenchymal stem cells via peripheral veins once a week for 8 weeks.
Patients in Group MSC-1 received standard medical treatment and infusions of umbilical cord blood mesenchymal stem cells via peripheral veins once a week for 4 weeks.
Patients in Group Control received standard medical treatment, including bed rest, nutritional supplementation, administration of human serum albumin (10g per day until serum albumin was 35g/L) and plasma (200 ml to 400 ml per day until the international normalized ratio was less than 1.5), anti-viral therapy, glycyrrhizin,S-adenosylmethionine and appropriate treatment for complications (such as infection, encephalopathy, hepatorenal syndrome and intestinal paralysis).
Outcomes
Primary Outcome Measures
The incidence of adverse reactions after umbilical cord blood derived mesenchymal stem cells (UC-MSC) infusions.
The survival time of patients after UC-MSC infusions.
Secondary Outcome Measures
The influence on levels of ALT (U/L) and AST (U/L) after UC-MSC infusions
The influence on levels of ALB(g/L) after UC-MSC infusions
The influence on levels of TBil (umol/L) after UC-MSC infusions
The influence on levels of INR after UC-MSC infusions
The influence on levels of MELD score, SOFA score and CTP score after UC-MSC infusions
The incidence of fatal complications after UC-MSC infusions.
Comparison of levels of NKG2A among the groups after UC-MSC infusions
Comparison of levels of NKG2D among the groups after UC-MSC infusions
Comparison of levels of NKP46 among the groups after UC-MSC infusions
Comparison of levels of KIR2DL1 among the groups after UC-MSC infusions
Comparison of levels of KIR2DL3 among the groups after UC-MSC infusions
Comparison of levels of KIR3DL1 among the groups after UC-MSC infusions
Comparison of levels of perforin among the groups after UC-MSC infusions
Comparison of levels of FasL among the groups after UC-MSC infusions
Comparison of levels of gramzymeB among the groups after UC-MSC infusions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02812121
Brief Title
UC-MSC Infusion for HBV-Related Acute-on-Chronic Liver Failure
Official Title
Umbilical Cord Blood Derived Mesenchymal Stem Cells Infusion for HBV-Related Acute-on-Chronic Liver Failure: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease with high mortality. Our previous study have demonstrated that peripheral infusion of bone marrow-derived mesenchymal stromal cells (MSCs) weekly for 4 times is safe and improves 24 weeks survival rate of ACLF patients. In this study, we intend to assess the safety and efficacy of umbilical cord blood derived MSCs for HBV-related ACLF patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
261 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group MSC-1
Arm Type
Experimental
Arm Description
Patients in Group MSC-1 received standard medical treatment and infusions of umbilical cord blood mesenchymal stem cells via peripheral veins once a week for 8 weeks.
Arm Title
Group MSC-2
Arm Type
Experimental
Arm Description
Patients in Group MSC-1 received standard medical treatment and infusions of umbilical cord blood mesenchymal stem cells via peripheral veins once a week for 4 weeks.
Arm Title
Group Control
Arm Type
No Intervention
Arm Description
Patients in Group Control received standard medical treatment, including bed rest, nutritional supplementation, administration of human serum albumin (10g per day until serum albumin was 35g/L) and plasma (200 ml to 400 ml per day until the international normalized ratio was less than 1.5), anti-viral therapy, glycyrrhizin,S-adenosylmethionine and appropriate treatment for complications (such as infection, encephalopathy, hepatorenal syndrome and intestinal paralysis).
Intervention Type
Drug
Intervention Name(s)
umbilical cord blood mesenchymal stem cells
Primary Outcome Measure Information:
Title
The incidence of adverse reactions after umbilical cord blood derived mesenchymal stem cells (UC-MSC) infusions.
Time Frame
52 weeks
Title
The survival time of patients after UC-MSC infusions.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
The influence on levels of ALT (U/L) and AST (U/L) after UC-MSC infusions
Time Frame
1,2,3,4,8,12,24,36,52weeks
Title
The influence on levels of ALB(g/L) after UC-MSC infusions
Time Frame
1,2,3,4,8,12,24,36,52weeks
Title
The influence on levels of TBil (umol/L) after UC-MSC infusions
Time Frame
1,2,3,4,8,12,24,36,52weeks
Title
The influence on levels of INR after UC-MSC infusions
Time Frame
1,2,3,4,8,12,24,36,52weeks
Title
The influence on levels of MELD score, SOFA score and CTP score after UC-MSC infusions
Time Frame
1,2,3,4,8,12,24,36,52weeks
Title
The incidence of fatal complications after UC-MSC infusions.
Time Frame
52 weeks
Title
Comparison of levels of NKG2A among the groups after UC-MSC infusions
Time Frame
2,4,8,12,24,36,52 weeks
Title
Comparison of levels of NKG2D among the groups after UC-MSC infusions
Time Frame
2,4,8,12,24,36,52 weeks
Title
Comparison of levels of NKP46 among the groups after UC-MSC infusions
Time Frame
2,4,8,12,24,36,52 weeks
Title
Comparison of levels of KIR2DL1 among the groups after UC-MSC infusions
Time Frame
2,4,8,12,24,36,52 weeks
Title
Comparison of levels of KIR2DL3 among the groups after UC-MSC infusions
Time Frame
2,4,8,12,24,36,52 weeks
Title
Comparison of levels of KIR3DL1 among the groups after UC-MSC infusions
Time Frame
2,4,8,12,24,36,52 weeks
Title
Comparison of levels of perforin among the groups after UC-MSC infusions
Time Frame
2,4,8,12,24,36,52 weeks
Title
Comparison of levels of FasL among the groups after UC-MSC infusions
Time Frame
2,4,8,12,24,36,52 weeks
Title
Comparison of levels of gramzymeB among the groups after UC-MSC infusions
Time Frame
2,4,8,12,24,36,52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with ACLF-which is characterized by acute hepatic insult manifesting as jaundice (serum total bilirubin ≥ 10×ULN umol/L) and coagulopathy (international normalized ratio≥ 1.5 or prothrombin activity < 40%), complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination, in patients with previously diagnosed or undiagnosed chronic liver disease;
Positive serum hepatitis B surface antigen (HBsAg) for more than 6 months;
End-stage liver disease scores ranging from 17-30,; 4.18-65 years of age.
Exclusion Criteria:
Serious complications within the previous 2 months (e.g. gastrointestinal bleeding, serious infection );
Concomitant autoimmune disease;
Superinfection with other hepatitis viruses;
Important organ dysfunctions not due to liver disease or malignancies;
Pregnancy and lactation;
Liver tumor or nodules secondary to cirrhosis proven by ultrasound, computerized tomography (CT), or magnetic resonance (MR) imaging;
Bioartificial liver support therapy;
Previous liver transplantation.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
UC-MSC Infusion for HBV-Related Acute-on-Chronic Liver Failure
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