Evaluation of the efficacy of cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells (P-MMSCs) in the treatment of chronic viral hepatitis and liver cirrhosis

Most clinical trials demonstrate a positive effect after the application of various types of stem/progenitor cells in the treatment of chronic hepatitis B and C related liver cirrhosis patients. Mesenchymal stem cells (MSCs) can be candidates for stem cell–based therapy for liver diseases. MSCs have immunomodulatory, anti-fibrosis and anti-inflammatory effects which improve liver function particularly reduced ascites and recovery of biliary enzymes and significantly increased survivals

Transplantation of allogeneic Placenta-Derived Multipotent Mesenchymal Stromal Cells (P-MMSCs) is a promising approach to increase the efficiency of therapy of liver cirrhosis in combination with the conventional treatment regime

Study aim: to evaluate the efficacy and safety of cryopreserved allogeneic P-MMSCs in the treatment in chronic hepatitis B and C related liver cirrhosis patients

Primary Endpoint:

  • Safety and efficiency of intrahepatic and intravenous injections of cryopreserved allogeneic P-MMSCs
  • Safety and efficiency of cryopreserved allogeneic P-MMSCs injections will be assessed by fixing clinical results and reviewing adverse events every three months during 1 year after the first procedure
  • Major adverse events were adjudicated: hospitalization, acute bleeding, multiple organ failure, tumor formation, death

Dosing regimen: patients with cirrhosis will receive P-MMSCs (treatment) or standard medical care (control)

Four times of MSC infusion (1×106 /kg body weight) via peripheral vein alone (once every 7 days (±3 days) or with single intrahepatic injection (target dose up to 60×106cells per organ) will be given to the experimental groups; control group – standard treatment only

No HLA matching or immunosuppression required

Evaluation of efficacy of cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells (P-MMSCs) in the treatment of chronic viral hepatitis and liver cirrhosis.  

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