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Mesenchymal Stem Cell Transplantation for 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: NCT03668171
Recruitment Status : Unknown
Verified September 2018 by Han Ying, Xijing Hospital of Digestive Diseases.
Recruitment status was:  Recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Han Ying, Xijing Hospital of Digestive Diseases

Tracking Information
First Submitted Date  ICMJE September 10, 2018
First Posted Date  ICMJE September 12, 2018
Last Update Posted Date September 12, 2018
Actual Study Start Date  ICMJE December 10, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
Efficacy: 12 week mortality rate [ Time Frame: 12 weeks ]
mortality rate assessed at week 12
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
Clinical remission rate at week 12 [ Time Frame: 12 weeks ]
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
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 Mesenchymal Stem Cell Transplantation for Acute-on-chronic Liver Failure
Official Title  ICMJE Mesenchymal Stem Cell Transplantation for Acute-on-chronic Liver Failure, a Randomized, Double Blind, Placebo Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Randomization will be blinded to participant, care provider, investigator and outcome assessors.
Primary Purpose: Treatment
Condition  ICMJE Acute-On-Chronic Liver Failure
Intervention  ICMJE Procedure: mesenchymal stem cell transplantation or placebo infusion via peripheral vein
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
Study Arms  ICMJE
  • Experimental: MSC group
    mesenchymal stem cell transplantation via peripheral vein: 0.1-1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 1, 2 weeks
    Intervention: Procedure: mesenchymal stem cell transplantation or placebo infusion via peripheral vein
  • Placebo Comparator: control
    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: Procedure: mesenchymal stem cell transplantation or placebo infusion via peripheral vein
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: September 10, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03668171
Other Study ID Numbers  ICMJE KY20172049-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Study protocol, statistical analysis processes and clinical data of individual participants will be shared.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Analytic Code
Time Frame: within 12 months after the study completion and before publications of the findings.
Responsible Party Han Ying, Xijing Hospital of Digestive Diseases
Study Sponsor  ICMJE Xijing Hospital of Digestive Diseases
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Xijing Hospital of Digestive Diseases
Verification Date September 2018

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