Safety and Efficacy Study of Umbilical Mesenchymal Stem Cells for Liver Cirrhosis (LC)

• Serum markers regarding liver and kidney function [ Time Frame: 0, 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]
  liver functions：Albumin (ALB), Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST), Prealbumin(PA), total bilirubin (TB), and direct bilirubin (DB) kidney function：Blood urea nitrogen (BUN), Urea (UA), and Crea (Cr)
• Serum markers regarding lipid and sugar profile [ Time Frame: 0, 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]
  Total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG), very low density lipoprotein cholesterol (VLDL-C), and Non-HDL-C; blood sugar;
• Serum markers regarding cytokine profile [ Time Frame: 0, 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]
  IL-1β, IL-4, IL-6, IL-8, IL-10, IL-12(p40), IL-15, IL-17A, TNFα, TNFβ, IFN-γ, RANTES, TGFβ, lymphotactin, and C-reactive protein level (CRP)
• Serum levels of Hepatitis B and C [ Time Frame: 0, 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]
  Serum levels of Hepatitis B and C
• tolerance and the adverse events [ Time Frame: 3-year follow up ] [ Designated as safety issue: Yes ]

  The classification for uncomfortable reaction is: 0, no discomfort; 1, slightly unwell, does not affect daily life; 2, moderate discomfort, affects daily life and work; 3, moderately unwell, significantly affects life, and bed rest; 4, severely unwell, life-threatening.

  A serious adverse event is defined as fatal, life threatening, permanently disabling, and tumors, particularly hepatocellular carcinoma.

• Changes of any clinical symptoms [ Time Frame: 3-year follow up ] [ Designated as safety issue: Yes ]
  abdominal distension, appetite, debilitation, and edema of lower limbs.

Liver cirrhosis and subsequent liver failure are leading causes of morbidity and mortality worldwide. Alcohol abuse and viral hepatitis are the most common causes of cirrhosis. Novel therapies are necessary to prevent or block the process of the disease. In this current prospective cohort, the investigators plan to organize four hospitals to determine the safety and efficacy of intravenous administration of umbilical mesenchymal stem cells in the treatment of patients with liver cirrhosis in next three years.

• Biological: mesenchymal stem cells
  Conventional therapy plus UC-MSC intravenous administration (4x107/40ml, once per three months, four times in one year)
• Biological: Conventional therapy
  Conventional therapy without cell therapy

• Sham Comparator: Conventional therapy
  only apply for conventional medical therapy without any cell therapy
  Intervention: Biological: Conventional therapy
• Active Comparator: mesenchymal stem cells
  combination of conventional therapy with umbilical mesenchymal stem cells intravenous injection, (4x107/40ml, once per three months, four times in one year)
  Intervention: Biological: mesenchymal stem cells

Inclusion Criteria:

• written informed consent
• aged 30-60 years
• clinical diagnosis of compensated or decompensated liver
• child-Pugh B/C (7-12 points)
• expecting lifetime is over three years

Exclusion Criteria:

• pregnant woman
• patient with severe vascular diseases
• patient with any organ failure
• patient with any tumors
• patient with HIV
• patient who has been transplanted
• patient treated with immunosuppressors
• patient for whom the follow-up is considered impossible
• patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject