Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis

Not Applicable

• Conditions: Liver Cirrhosis
• Interventions: Procedure: mesenchymal stem cell transplantation via peripheral vein; Other: mesenchymal stem cell

• Registration Number: NCT03209986
• Lead Sponsor: Xijing Hospital of Digestive Diseases

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 available

Study Timeline

• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-07-05
• Study First Posted: 2017-07-06
• Study Start: 2017-11-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-11
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Efficacy: Change of liver functions as assessed by MELD score	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	1 year	Adverse events as assessed according to CTCAE 4.03

Secondary Outcome Measures

Name	Time	Method
Histological change of the liver: Histological scores assessed by liver biopsy	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	1, 2 and 5 years	Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy
Survival Benefit: Survival Rate at different time points	1 year, 2 year and 5 years	survival rate at different time points

Trial Locations

Locations (1)

Xijing Hospital of Digestive Disease, Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China