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Clinical Trial of Umbilical Cord Mesenchymal Stem Cell Transfusion in Decompensated Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT03529136
Recruitment Status : Not yet recruiting
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Collaborators:
Shanghai Public Health Clinical Center
First Affiliated Hospital of Fujian Medical University
Yantai Hospital for Infectious Diseases
The Second Affiliated Hospital of Chongqing Medical University
Jinan Hospital for Infectious Diseases
Information provided by (Responsible Party):
Shandong Qilu Stem Cells Engineering Co., Ltd.

Tracking Information
First Submitted Date  ICMJE May 6, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date May 18, 2018
Estimated Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2018)
overall survival [ Time Frame: one year ]
The overall survival ratio of three groups will be detection after infusion in one year.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Umbilical Cord Mesenchymal Stem Cell Transfusion in Decompensated Liver Cirrhosis
Official Title  ICMJE A Prospective Multicenter Clinical Study to Evaluate The Safety and Efficiency of Human Umbilical Cord Mesenchymal Stem Cell Transfusion in Patients With Decompensated Liver Cirrhosis.
Brief Summary Decompensated liver cirrhosis is one of the life-threatening complication of chronic liver disease. Liver transplantation currently is the only effective method that can improve the survival of these patients. However, the severe shortage of donor livers, high cost, and potential serious complications have restricted the availability of liver transplantation.Umbilical cord mesenchymal stem cells (UC-MSC) has been generally shown to be safe and effective for liver diseases in some pre-clinical and clinical studies. This study aim to evaluate the safety and efficiency of human umbilical cord mesenchymal stem cell transfusion in patients with decompensated liver cirrhosis, and explore the best protocol of MSC transfusion.
Detailed Description This study is a multicenter non randomized control study. Patients with decompensated liver cirrhosis are going to be assigned to receive standard medical care plus UC-MSC treatment with two different protocol (group 1 and group 2) or standard medical care (control). Four times of MSC infusion (1.5x10E6 cells/kg body weight) via peripheral vein will be given to the group 1(once every 4 days), and two times of MSC infusion once every 7 days to the group 2. The primary outcome is survival rates in one year. Secondary outcomes are liver function, liver ascites and MELD score.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients with decompensated liver cirrhosis are going to be assigned to receive standard medical care plus UC-MSC treatment with two different protocol (group 1 and group 2) or standard medical care (control). Four times of MSC infusion (1.5x10E6 cells/kg body weight) via peripheral vein will be given to the group 1(once every 4 days), and two times of MSC infusion once every 7 days to group 2.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Decompensated Liver Cirrhosis
Intervention  ICMJE Biological: UC-MSC
Human umbilical cord mesenchymal stem cells have driven from Wharton's jelly and cultured with serum-free medium in Shandong Cell and tissue bank. All of the cells in this study within three passages. Before transfusion, the mesenchymal stem cells were subjected to quality control. The UC-MSC were stained with anti-CD90-FITC, Anti-CD44-FITC, Anti-CD34-FITC and anti-45-FITC.
Other Name: Human umbilical cord mesenchymal stem cells
Study Arms  ICMJE
  • Experimental: MSC group 1
    Procedure:UC-MSC infusion via peripheral vein. Four times of MSC infusion (1.5x10E6 cells/kg body weight) via peripheral vein will be given to the group 1(once every 4 days).
    Intervention: Biological: UC-MSC
  • Experimental: MSC group 2
    Procedure:UC-MSC infusion via peripheral vein. Two times of MSC infusion (1.5x10E6 cells/kg body weight) via peripheral vein will be given to the group 2(once every 7 days).
    Intervention: Biological: UC-MSC
  • Experimental: Control group
    Control group with standard medical care. UC-MSC infusion could be considering in this group after 24 weeks' followed-up.
    Intervention: Biological: UC-MSC
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2018)
252
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Clinically diagnosed as decompensated liver cirrhosis.
  2. Hepatitis B/C Liver Cirrhosis After Viral Treatment, HBV/HCV Viral Loads Below Detection Level over six mouths, and the liver function remained below Child-pugh A grade or MELD score >10.
  3. Other causes of cirrhosis, liver function compensatory incomplete.
  4. In the past year, despite active medical treatment taken, the condition has continued to increase, at least because of cirrhosis complications such as ascites, spontaneous peritonitis, gastrointestinal bleeding, and hepatic encephalopathy in hospital over one time.
  5. Need to intermittently supplement albumin and apply diuretic therapy.
  6. Albumin <35 g/L, total bilirubin <170 umol/L, prothrombin activity> 30%; (Prothrombin time <20 s, moderate or lower mass ascites, spontaneous peritonitis and hepatic encephalopathy (grade II or lower), Child-pugh score> 5 points).
  7. There was no history of gastrointestinal hemorrhage within the last month and population with no high-risk portal hypertension and gastrointestinal bleeding was evaluated recently.
  8. Unconditional acceptance of orthotopic liver transplantation.
  9. Aged from 18 to 65 years.
  10. Voluntarily signed informed consent form.

Exclusion Criteria:

  1. A malignant tumor with liver or other organs or a history of previous cancer.
  2. Complications include gastrointestinal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome, and Acute infection episodes.
  3. Patients with severe heart, lung, kidney or blood system diseases and failure status.
  4. Pregnant or lactating women.
  5. Allergic constitution.
  6. There is a history of alcohol abuse, drug abuse, and failure to effectively quit. 7. Patients did not participate in other clinical trials within 4 weeks.

8. Any condition, investigator believe that patients should not participate in this study.

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: Xie +86 13256735916 mm-xie@hotmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03529136
Other Study ID Numbers  ICMJE CTR1800015304
Has Data Monitoring Committee Yes
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 Shandong Qilu Stem Cells Engineering Co., Ltd.
Study Sponsor  ICMJE Shandong Qilu Stem Cells Engineering Co., Ltd.
Collaborators  ICMJE
  • Shanghai Public Health Clinical Center
  • First Affiliated Hospital of Fujian Medical University
  • Yantai Hospital for Infectious Diseases
  • The Second Affiliated Hospital of Chongqing Medical University
  • Jinan Hospital for Infectious Diseases
Investigators  ICMJE
Principal Investigator: Jingbo Wang Jinan Hospital for Infectious Diseases
PRS Account Shandong Qilu Stem Cells Engineering Co., Ltd.
Verification Date March 2018

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