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UC-MSC Infusion for HBV-Related Acute-on-Chronic Liver Failure

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ClinicalTrials.gov Identifier: NCT02812121
Recruitment Status : Unknown
Verified June 2016 by Lin Bingliang, Sun Yat-sen University.
Recruitment status was:  Not yet recruiting
First Posted : June 24, 2016
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
Lin Bingliang, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Liver Failure Drug: umbilical cord blood mesenchymal stem cells Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Umbilical Cord Blood Derived Mesenchymal Stem Cells Infusion for HBV-Related Acute-on-Chronic Liver Failure: A Randomized Controlled Trial
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018

Arm Intervention/treatment
Experimental: Group MSC-1
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.
Drug: umbilical cord blood mesenchymal stem cells
Experimental: Group MSC-2
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.
Drug: umbilical cord blood mesenchymal stem cells
No Intervention: Group Control
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).



Primary Outcome Measures :
  1. The incidence of adverse reactions after umbilical cord blood derived mesenchymal stem cells (UC-MSC) infusions. [ Time Frame: 52 weeks ]
  2. The survival time of patients after UC-MSC infusions. [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. The influence on levels of ALB(g/L) after UC-MSC infusions [ Time Frame: 1,2,3,4,8,12,24,36,52weeks ]
  3. The influence on levels of TBil (umol/L) after UC-MSC infusions [ Time Frame: 1,2,3,4,8,12,24,36,52weeks ]
  4. The influence on levels of INR after UC-MSC infusions [ Time Frame: 1,2,3,4,8,12,24,36,52weeks ]
  5. 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 ]
  6. The incidence of fatal complications after UC-MSC infusions. [ Time Frame: 52 weeks ]
  7. Comparison of levels of NKG2A among the groups after UC-MSC infusions [ Time Frame: 2,4,8,12,24,36,52 weeks ]
  8. Comparison of levels of NKG2D among the groups after UC-MSC infusions [ Time Frame: 2,4,8,12,24,36,52 weeks ]
  9. Comparison of levels of NKP46 among the groups after UC-MSC infusions [ Time Frame: 2,4,8,12,24,36,52 weeks ]
  10. Comparison of levels of KIR2DL1 among the groups after UC-MSC infusions [ Time Frame: 2,4,8,12,24,36,52 weeks ]
  11. Comparison of levels of KIR2DL3 among the groups after UC-MSC infusions [ Time Frame: 2,4,8,12,24,36,52 weeks ]
  12. Comparison of levels of KIR3DL1 among the groups after UC-MSC infusions [ Time Frame: 2,4,8,12,24,36,52 weeks ]
  13. Comparison of levels of perforin among the groups after UC-MSC infusions [ Time Frame: 2,4,8,12,24,36,52 weeks ]
  14. Comparison of levels of FasL among the groups after UC-MSC infusions [ Time Frame: 2,4,8,12,24,36,52 weeks ]
  15. Comparison of levels of gramzymeB among the groups after UC-MSC infusions [ Time Frame: 2,4,8,12,24,36,52 weeks ]


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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. 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;
  2. Positive serum hepatitis B surface antigen (HBsAg) for more than 6 months;
  3. End-stage liver disease scores ranging from 17-30,; 4.18-65 years of age.

Exclusion Criteria:

  1. Serious complications within the previous 2 months (e.g. gastrointestinal bleeding, serious infection );
  2. Concomitant autoimmune disease;
  3. Superinfection with other hepatitis viruses;
  4. Important organ dysfunctions not due to liver disease or malignancies;
  5. Pregnancy and lactation;
  6. Liver tumor or nodules secondary to cirrhosis proven by ultrasound, computerized tomography (CT), or magnetic resonance (MR) imaging;
  7. Bioartificial liver support therapy;
  8. Previous liver transplantation.

Responsible Party: Lin Bingliang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02812121     History of Changes
Other Study ID Numbers: UCBMSC
LBingliang ( Registry Identifier: Bing-liang Lin )
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Liver Failure
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Liver Failure, Acute