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

Primary Purpose

Decompensated Liver Cirrhosis

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

UC-MSC

About this trial

This is an interventional treatment trial for Decompensated Liver Cirrhosis focused on measuring Mesenchymal Stem Cell, MSC

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinically diagnosed as decompensated liver cirrhosis.
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.
Other causes of cirrhosis, liver function compensatory incomplete.
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.
Need to intermittently supplement albumin and apply diuretic therapy.
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).
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.
Unconditional acceptance of orthotopic liver transplantation.
Aged from 18 to 65 years.
Voluntarily signed informed consent form.

Exclusion Criteria:

A malignant tumor with liver or other organs or a history of previous cancer.
Complications include gastrointestinal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome, and Acute infection episodes.
Patients with severe heart, lung, kidney or blood system diseases and failure status.
Pregnant or lactating women.
Allergic constitution.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

MSC group 1

MSC group 2

Control group

Arm Description

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).

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).

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

Outcomes

Primary Outcome Measures

overall survival

The overall survival ratio of three groups will be detection after infusion in one year.

Secondary Outcome Measures

Full Information

NCT ID

NCT03529136

First Posted

May 6, 2018

Last Updated

May 7, 2018

Sponsor

Shandong Qilu Stem Cells Engineering Co., Ltd.

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

1. Study Identification

Unique Protocol Identification Number

NCT03529136

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2018 (Anticipated)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

April 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shandong Qilu Stem Cells Engineering Co., Ltd.

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Decompensated Liver Cirrhosis

Keywords

Mesenchymal Stem Cell, MSC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MSC group 1

Arm Type

Experimental

Arm Description

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).

Arm Title

MSC group 2

Arm Type

Experimental

Arm Description

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).

Arm Title

Control group

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

UC-MSC

Other Intervention Name(s)

Human umbilical cord mesenchymal stem cells

Intervention Description

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.

Primary Outcome Measure Information:

Title

overall survival

Description

The overall survival ratio of three groups will be detection after infusion in one year.

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinically diagnosed as decompensated liver cirrhosis. 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. Other causes of cirrhosis, liver function compensatory incomplete. 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. Need to intermittently supplement albumin and apply diuretic therapy. 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). 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. Unconditional acceptance of orthotopic liver transplantation. Aged from 18 to 65 years. Voluntarily signed informed consent form. Exclusion Criteria: A malignant tumor with liver or other organs or a history of previous cancer. Complications include gastrointestinal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome, and Acute infection episodes. Patients with severe heart, lung, kidney or blood system diseases and failure status. Pregnant or lactating women. Allergic constitution. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xie

Phone

+86 13256735916

mm-xie@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jingbo Wang

Organizational Affiliation

Jinan Hospital for Infectious Diseases

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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