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Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT03209986
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Han Ying, Xijing Hospital of Digestive Diseases

Tracking Information
First Submitted Date  ICMJE June 30, 2017
First Posted Date  ICMJE July 6, 2017
Last Update Posted Date September 11, 2018
Actual Study Start Date  ICMJE November 8, 2017
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
  • Efficacy: Change of liver functions as assessed by MELD score [ Time Frame: 1 year ]
    Change of liver functions as assessed by MELD score (MELD, Model for End-Stage Liver Disease Score: MELD = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43)
  • Safety: Adverse events as assessed according to CTCAE 4.03 [ Time Frame: 1 year ]
    Adverse events as assessed according to CTCAE 4.03
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03209986 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
  • Survival Benefit: Survival Rate at different time points [ Time Frame: 1 year, 2 year and 5 years ]
    survival rate at different time points
  • Histological change of the liver: Histological scores assessed by liver biopsy [ Time Frame: 1 year, 2 year and 5 years ]
    histological scores assessed by liver biopsy at baseline and after treatment
  • Clinical benefit: Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy [ Time Frame: 1, 2 and 5 years ]
    Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy
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 Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis
Official Title  ICMJE Randomized Control Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis Resulted From Viral Hepatitis
Brief Summary

There has been great interest in recent years to take advantage of stem cells to treat liver cirrhosis. Mesenchymal stem cells (MSC) has been shown to be safe and effective for liver diseases in some studies. Randomization controlled studies are needed to confirm the long term effect of MSC treatment for liver cirrhosis. This study aimed to investigate the safety and efficacy of mesenchymal stem cells in hepatitis B and C related liver cirrhosis patients.

This study is an open-label multicenter randomized control study. Patients with with decompensated cirrhosis will be randomly assigned to receive MSC treatment plus standard medical care(treatment)or standard medical care (control). Three times of MSC infusion (1x10E6 cells/kg body weight) via peripheral vein will be given to the experimental group (once in 4 weeks). The primary outcome is absolute change in liver function indexes and and scores. Secondary outcomes are cirrhosis-related complications, symptoms, life quality, and survival.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Outcome assessors will be blind to the randomization results of the participants.
Primary Purpose: Treatment
Condition  ICMJE Liver Cirrhosis
Intervention  ICMJE
  • Procedure: mesenchymal stem cell transplantation via peripheral vein
    1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8
  • Other: mesenchymal stem cell
    mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China
Study Arms  ICMJE
  • Experimental: MSC group
    mesenchymal stem cell transplantation via peripheral vein: 1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 4, 8.
    Interventions:
    • Procedure: mesenchymal stem cell transplantation via peripheral vein
    • Other: mesenchymal stem cell
  • No Intervention: control
    Standard medication for viral hepatitis and cirrhosis
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged 18-65 years
  2. HBV -related liver cirrhosis
  3. Child-Pugh score ≥7
  4. With presentations of decompensation
  5. Written consent

Exclusion Criteria:

  1. Hepatocellular carcinoma or other malignancies
  2. Severe problems in other vital organs(e.g.the heart,renal or lungs)
  3. Pregnant or lactating women
  4. Severe bacteria infection
  5. Anticipated with difficulty of follow-up observation
  6. Coinfection with HIV or other viral hepatitis.
  7. Drug abuse or alcohol abuse
  8. History of severe allergy to biological products
  9. Other candidates who are judged to be not applicable to this study by doctors -
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: Changcun Guo, MD 862984771539 guochc@fmmu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03209986
Other Study ID Numbers  ICMJE XJMSC0001
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 Not Provided
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