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Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis

Primary Purpose

Liver Cirrhosis

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

mesenchymal stem cell transplantation via peripheral vein

mesenchymal stem cell

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Liver Cirrhosis, Mesenchymal Sem Cells

Eligibility Criteria

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

Inclusion Criteria:

Aged 18-65 years
HBV -related liver cirrhosis
Child-Pugh score ≥7
With presentations of decompensation
Written consent

Exclusion Criteria:

Hepatocellular carcinoma or other malignancies
Severe problems in other vital organs(e.g.the heart,renal or lungs)
Pregnant or lactating women
Severe bacteria infection
Anticipated with difficulty of follow-up observation
Coinfection with HIV or other viral hepatitis.
Drug abuse or alcohol abuse
History of severe allergy to biological products
Other candidates who are judged to be not applicable to this study by doctors -

Sites / Locations

Xijing Hospital of Digestive Disease, Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MSC group

control

Arm Description

mesenchymal stem cell transplantation via peripheral vein: 1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 4, 8.

Standard medication for viral hepatitis and cirrhosis

Outcomes

Primary Outcome Measures

Efficacy: Change of liver functions as assessed by MELD score

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

Adverse events as assessed according to CTCAE 4.03

Secondary Outcome Measures

Survival Benefit: Survival Rate at different time points

survival rate at different time points

Histological change of the liver: Histological scores assessed by liver biopsy

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

Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy

Full Information

NCT ID

NCT03209986

First Posted

June 30, 2017

Last Updated

September 10, 2018

Sponsor

Xijing Hospital of Digestive Diseases

1. Study Identification

Unique Protocol Identification Number

NCT03209986

Brief Title

Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis

Official Title

Randomized Control Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis Resulted From Viral Hepatitis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 8, 2017 (Actual)

Primary Completion Date

June 30, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xijing Hospital of Digestive Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Liver Cirrhosis

Keywords

Liver Cirrhosis, Mesenchymal Sem Cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Outcome assessors will be blind to the randomization results of the participants.

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MSC group

Arm Type

Experimental

Arm Description

mesenchymal stem cell transplantation via peripheral vein: 1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 4, 8.

Arm Title

control

Arm Type

No Intervention

Arm Description

Standard medication for viral hepatitis and cirrhosis

Intervention Type

Procedure

Intervention Name(s)

mesenchymal stem cell transplantation via peripheral vein

Intervention Description

1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8

Intervention Type

Other

Intervention Name(s)

mesenchymal stem cell

Intervention Description

mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China

Primary Outcome Measure Information:

Title

Efficacy: Change of liver functions as assessed by MELD score

Description

Time Frame

1 year

Title

Safety: Adverse events as assessed according to CTCAE 4.03

Description

Adverse events as assessed according to CTCAE 4.03

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Survival Benefit: Survival Rate at different time points

Description

survival rate at different time points

Time Frame

1 year, 2 year and 5 years

Title

Histological change of the liver: Histological scores assessed by liver biopsy

Description

histological scores assessed by liver biopsy at baseline and after treatment

Time Frame

1 year, 2 year and 5 years

Title

Clinical benefit: Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy

Description

Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy

Time Frame

1, 2 and 5 years

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: Aged 18-65 years HBV -related liver cirrhosis Child-Pugh score ≥7 With presentations of decompensation Written consent Exclusion Criteria: Hepatocellular carcinoma or other malignancies Severe problems in other vital organs(e.g.the heart,renal or lungs) Pregnant or lactating women Severe bacteria infection Anticipated with difficulty of follow-up observation Coinfection with HIV or other viral hepatitis. Drug abuse or alcohol abuse History of severe allergy to biological products Other candidates who are judged to be not applicable to this study by doctors -

Central Contact Person:

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

Changcun Guo, MD

Phone

862984771539

guochc@fmmu.edu.cn

Facility Information:

Facility Name

Xijing Hospital of Digestive Disease, Xijing Hospital

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ying Han, Ph.D

Phone

86-29-84771539

hanying@fmmu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis

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