Mesenchymal Stem Cells Treatment for Decompensated Liver Cirrhosis
Mesenchymal Stem Cells Treatment for Decompensated Liver Cirrhosis
Decompensated liver cirrhosis is a life-threatening chronic liver disease with high
 mortality. Liver transplantation is the only option that can improve the survival of these
 patients; however, this procedure is associated with several limitations, such as the severe
 shortage of donor livers, long waiting lists, multiple complications, and high cost. Our and
 other previous studies have demonstrated that marrow bone-derived mesenchymal stem cells
 (BM-MSC) or unbilical cord derived MSC (UC-MSC) infusion is clinically safe and could improve
 liver function in patients with decompensated liver cirrhosis. However, the long-term
 outcomes of MSC infusion have not been reported until now. This prospective and randomized
 controlled study examined the longer-term safety and efficacy of UC-MSC in patients with
 decompensated liver cirrhosis.
Liver cirrhosis represents a late stage of progressive hepatic fibrosis characterized by the
 formation and accumulation of an extracellular matrix, which leads to the progressive
 distortion of the hepatic architecture. In China, the most important cause of liver cirrhosis
 is chronic hepatitis B virus (HBV) infection. Liver cirrhosis usually progresses irreversibly
 into advanced stage, such as a decompensated stage which is characterized by a series of
 clinical manifestations, including ascites, variceal hemorrhage, and hepatic encephalopathy
 with high mortality. Liver transplantation is the only option that can improve the survival
 of these decompensated liver cirrhosis patients; however, this procedure is associated with
 several limitations, such as the severe shortage of donor livers, long waiting lists,
 multiple complications, and high cost. Therefore, it is urgent to find a safe and effective
 therapeutic approach to decompensated liver cirrhosis.

 Animal models have shown that bone marrow-derived MSC (BM-MSC) can ameliorate liver fibrosis
 and reverse fulminant hepatic failure. In clinical, autologous BM-MSC have significantly
 improved liver function in patients with liver cirrhosis. A recent research also found that
 autologous BM-MSC therapy safely improved histological fibrosis and liver function in
 patients with alcoholic cirrhosis. Allogeneic MSC therapy, such as umbilical cord-derived MSC
 (UC-MSC), have shown to be safe and beneficial for the patients with liver cirrhosis caused
 by autoimmune diseases. Our previous studies showed that infusions of UC-MSC significantly
 improved liver function in decompensated liver cirrhosis and primary biliary cirrhosis (PBC)
 patients and increased the survival rate in acute-on-chronic liver failure (ACLF) patients.
 However, the single-center clinical study, the relative small size of the patient cohorts,
 absence of evaluation on long-term efficacy prevent firm conclusions being made with regard
 to the safety and efficacy of this treatment in liver diseases.

 The purpose of this study is to investigate whether and how UC-MSC can improve the liver
 function, and the incidence of serious complications in patients with decompensated liver
 cirrhosis through a multi-center clinical study.
Inclusion Criteria:

 1. Age 18-69 years;

 2. Decompensated liver cirrhosis (manifestations including gastrointestinal bleeding,
 hepatic encephalopathy, and ascites, based on previously stable cirrhosis);

 3. Positive testing for serum hepatitis B surface antigen (HBsAg) for more than 6 months
 (chronic hepatitis B patients);

 4. Written consent.

 Exclusion Criteria:

 1. Hepatocellular carcinoma or other malignancies;

 2. Liver cirrhosis caused by other reasons, such as autoimmune diseases, alcocal, drugs
 and so on;

 3. Pregnant women;

 4. The presence of other vital organ severe dysfunction;

 5. Participate in other studies;

 6. Lack of a supportive family;

 7. Refusal to sign the informed consent form.