Umbilical Cord Mesenchymal Stem Cells for Patients With Liver Cirrhosis
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Liver cirrhosis (LC) represents a late stage of progressive hepatic fibrosis characterized by
      distortion of the hepatic architecture and formation of regenerative nodules. The liver
      transplantation is one of the only effective therapies available to such patients. However,
      lack of donors, surgical complications, rejection, and high cost are it's serious problems.
      The potential for stem cells to differentiate into hepatocytes cells was recently confirmed.
      Particularly, autologous bone marrow-derived mesenchymal stem cell (BM-MSC) has been
      demonstrated to decrease MELD score and increase serum albumin in the patients with
      decompensated liver cirrhosis. Therefore, the investigators propose a hypothesis that
      umbilical cord-derived MSCs (UC-MSC) can also improve the disease conditions of LC patients,
      particularly reducing the decompensated conditions in these patients.
    

Detailed description: 
      Liver cirrhosis (LC) represents a late stage of progressive hepatic fibrosis characterized by
      distortion of the hepatic architecture and formation of regenerative nodules. The liver
      transplantation is one of the only effective therapies available to such patients. However,
      lack of donors, surgical complications, rejection, and high cost are it's serious problems.

      The potential for stem cells to differentiate into hepatocytes cells was recently confirmed.
      In particular, bone marrow-derived mesenchymal stem cell (BM-MSC) transplantation has been
      applicated in the clinic for treat several human diseases such as GVHD, cardiac injury and
      brain injury, and displayed good tolerance and efficiency. BM-MSC has also been used to treat
      human liver diseases such as liver failure and liver cirrhosis. In a phase 1 study,
      autologous BM-MSC transplantation has potential to decrease MELD score and increase serum
      albumin in the patients with decompensated liver cirrhosis.

      The purpose of this study is to learn whether and how umbilical cord-derived MSCs (UC-MSC)
      can improve the longer term survival in patients with liver cirrhosis. This study will also
      look at how well BM-MSC is tolerated and its safety in LC patients.

      Participants in the study will be randomly assigned to one of two treatment arms:

      Arm A: Participants will receive conserved treatment plus three times UC-MSC treatment at
      4-week intervals.

      Arm B: Participants will receive conserved treatment plus three times saline infusions at
      4-week intervals.

      UC-MSC will be prepared according to standard procedures and is collected in plastic bags
      containing anti coagulant. MSCs are infused intravenously. After cell therapy, patients are
      followed up for 75 months. The evaluation of some clinical parameters such as the level of
      serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin
      (ALB), prealbumin(PA), the rountin blood test are detected at week 12, 24, 48 timepoints.
      Clinical symptoms as well as complication were also observed simultaneously.
    

Intervention name(s): conventional plus MSC treatment; conventional plus placebo treatment
Intervention type(s): Drug; Drug
Intervention description(s): received conventional treatment and taken i.v., once per 4 week, at a dose of 0.5*10E6 MSC/kg body for 8 weeks.; received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: liver cirrhosis; mesenchymal stem cells; longer term survival; safety