Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Liver Failure

Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Liver Failure

Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Acute-on-Chronic Liver Failure Caused by Hepatitis B Virus (HBV)

Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. Although liver transplantation provides an option to cure patients suffering with LF, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) the novel and promising therapeutic strategy, BM-MSCs can replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. Plasma exchange (PE) can improve internal environment by removing endotoxin, it helps the liver regeneration and functional recovery and make UC-MSC differentiation into hepatocyte like cells, and exert immunomodulatory function. In this study, safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B Virus will be evaluated.

To investigate safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B virus.

Participants will receive conventional treatment plus a dose of UC-MSC and then be followed until the week 48 study visit.

Participants will receive conventional treatment plus plasma exchange and then be followed until the week 48 study visit.

Participants will receive conventional treatment plus umbilical cord mesenchymal stem cells transplantation combined with plasma exchange. Participants will then be followed until the week 48 study visit.

Received conventional treatment and umbilical cord mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×105/Kg, once a week, 4 times).

Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times). Meantime taken i.v umbilical cord mesenchymal stem cells transplantation slowly for 30minutes (1×105/Kg, once a week, 4 times), the first two times is taken after plasma exchange.

Received conventional treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

Improve biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT), INR and so on]

The clinical symptom improvement [including appetite, debilitation, abdominal distension, edema of lower limbs, et al]

Inclusion Criteria: Written informed consent Acute-on-Chronic liver failure caused by hepatitis B virus Model for End-Stage Liver Disease (MELD) <30 Exclusion Criteria: Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on History of severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment Severe problems in other vital organs(e.g. the heart, renal or lungs) Severe bacteria infection Tumor on ultrasonography, CT or MRI examination Pregnant or lactating women

Xu WX, He HL, Pan SW, Chen YL, Zhang ML, Zhu S, Gao ZL, Peng L, Li JG. Combination Treatments of Plasma Exchange and Umbilical Cord-Derived Mesenchymal Stem Cell Transplantation for Patients with Hepatitis B Virus-Related Acute-on-Chronic Liver Failure: A Clinical Trial in China. Stem Cells Int. 2019 Feb 4;2019:4130757. doi: 10.1155/2019/4130757. eCollection 2019.