Mesenchymal Stem Cells Treat Liver Cirrhosis

• The level of serum alanine aminotransferase (ALT） [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• The level of serum total bilirubin (TB) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• The level of serum prothrombin time (PT) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• The level of serum prealbumin(PA) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• The level of serum albumin (ALB) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

• liver biopsy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• The level of serum alanine aminotransferase (ALT） [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• The level of serum total bilirubin (TB) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• The level of serum prothrombin time (PT) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• The level of serum albumin (ALB) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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.

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.

• Drug: Conserved Therapy
  Conserved Therapy
• Procedure: Hepatic artery infusion or Intravenous infusion
  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 for 30-60 minutes in the intravenous infusion group. The control group will receive conserved therapy.

• Active Comparator: Conserved Therapy
  Conserved Therapy
  Intervention: Drug: Conserved Therapy
• Experimental: Interventional Therapy

  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.

  Intervention: Procedure: Hepatic artery infusion or Intravenous infusion

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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.