Mesenchymal Stem Cells Treat Liver Cirrhosis

Phase 1

Suspended

• Conditions: Liver Cirrhosis
• Interventions: Drug: Conserved Therapy; Procedure: Hepatic artery infusion or Intravenous infusion

• Registration Number: NCT01233102
• Lead Sponsor: Yufang Shi

Brief Summary

The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) transfusion in the treatment of liver cirrhosis. Liver function will be monitored by serum analysis. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA) and albumin (ALB) will be examined at pre-transfusion, and 3 days to 2 years post-transfusion. Child-Pugh scores, Model for End-Stage Liver Disease scores and clinical symptoms will be assessed simultaneously.

Detailed Description

Patients with liver cirrhosis will be randomly divided into three groups. Umbilical cord MSCs will be infused to patients using interventional method via hepatic artery for one group. The catheter will be inserted to proper hepatic artery. After the catheter placement confirmed by angiography, umbilical cord MSCs will be infused slowly in 20-30 minutes. Umbilical cord MSCs will be infused intravenously slowly in 30-60 minutes in the intravenous infusion group. The control group will receive conserved therapy. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA)and albumin (ALB) will be examined at re-transplantation, and 3 days to 2 years post-transplantation. The efficacy of umbilical cord MSCs transfusion will be investigated. The efficacy of different interventional therapies will also be compared.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-19
• Last Update Posted: 2016-02-22
• Primary Completion: 2017-12
• Study Completion: 2019-12

Recruitment & Eligibility

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

Inclusion Criteria

• Age 18-70 years.
• Imaging evidences of liver cirrhosis.
• Child-Plough score of 8 or more.
• Model for End-Stage Liver Disease score of 20 or more.

Exclusion Criteria

• Liver tumor on ultrasonography, CT or MRI examination.
• Problems in organs other than liver (e.g. heart or lungs).
• History of moderate to severe hepatic encephalopathy or variceal bleeding.
• Imaging evidences of vascular thromboses.
• Coma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conserved Therapy	Conserved Therapy	Conserved Therapy
Interventional Therapy	Hepatic artery infusion or Intravenous infusion	Patients with liver cirrhosis will be randomly divided into three groups. 1. Umbilical cord MSCs will be infused to patients using interventional method via hepatic artery for one group.2. Umbilical cord MSCs will be infused to patients intravenously for another group. The control group will receive conserved therapy. The efficacy of different interventional therapies will be compared.

Primary Outcome Measures

Name	Time	Method
The level of serum total bilirubin (TB)	1 year
Overall survival	1 year
The level of serum prealbumin(PA)	1 year
The level of serum alanine aminotransferase (ALT）	1 year
The level of serum prothrombin time (PT)	1 year
The level of serum albumin (ALB)	1 year

Secondary Outcome Measures

Name	Time	Method
The level of serum prothrombin time (PT)	2 years
liver biopsy	2 years
Overall survival	2 years
The level of serum alanine aminotransferase (ALT）	2 years
The level of serum total bilirubin (TB)	2 years
The level of serum albumin (ALB)	2 years

Trial Locations

Locations (1)

First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China