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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Umbilical Cord Blood Derived Mesenchymal Stem Cells Infusion for HBV-Related Acute-on-Chronic Liver Failure: A Randomized Controlled Trial

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.

Detailed Summary:
Sponsor: Sun Yat-sen University

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: May 27, 2016
Date Started: June 2016
Date Completion: June 2018
Last Updated: June 21, 2016
Last Verified: June 2016