Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

UC-MSC Infusion for HBV-Related 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: 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

Tracking Information
First Submitted Date  ICMJE May 27, 2016
First Posted Date  ICMJE June 24, 2016
Last Update Posted Date June 24, 2016
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
  • 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 Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE UC-MSC Infusion for HBV-Related Acute-on-Chronic Liver Failure
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Failure
Intervention  ICMJE Drug: umbilical cord blood mesenchymal stem cells
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 21, 2016)
261
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2018
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02812121
Other Study ID Numbers  ICMJE UCBMSC
LBingliang ( Registry Identifier: Bing-liang Lin )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Lin Bingliang, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Yat-sen University
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP