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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.

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.

Condition or disease Intervention/treatment Phase
Decompensated Liver Cirrhosis Biological: UC-MSC Phase 2

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 : Interventional
Estimated Enrollment : 252 participants
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
Official Title: 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.
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
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

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).
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

Experimental: Control group
Control group with standard medical care. UC-MSC infusion could be considering in this group after 24 weeks' followed-up.
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




Primary Outcome Measures :
  1. overall survival [ Time Frame: one year ]
    The overall survival ratio of three groups will be detection after infusion in one year.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529136


Contacts
Contact: Xie +86 13256735916 mm-xie@hotmail.com

Sponsors and Collaborators
Shandong Qilu Stem Cells Engineering Co., Ltd.
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
Principal Investigator: Jingbo Wang Jinan Hospital for Infectious Diseases

Responsible Party: Shandong Qilu Stem Cells Engineering Co., Ltd.
ClinicalTrials.gov Identifier: NCT03529136     History of Changes
Other Study ID Numbers: CTR1800015304
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shandong Qilu Stem Cells Engineering Co., Ltd.:
Mesenchymal Stem Cell
MSC

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases