Mesenchymal Stem Cells Treat Liver Cirrhosis

Yufang Shi

Status and phase: Suspended; Phase 2; Phase 1

Conditions: Liver Cirrhosis

Treatments: Procedure: Hepatic artery infusion or Intravenous infusion; Drug: Conserved Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01233102

SIBS-IHS-20101010

2010CB945600 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Conserved Therapy

Active Comparator group

Description:

Conserved Therapy

Treatment:

Drug: Conserved Therapy

Interventional Therapy

Experimental group

Description:

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.

Treatment:

Procedure: Hepatic artery infusion or Intravenous infusion