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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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).
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.
Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGSurvival rate and time
Time frame: 48 weeks
Improve biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT), INR and so on]
Time frame: 24 weeks after treatment
The clinical symptom improvement [including appetite, debilitation, abdominal distension, edema of lower limbs, et al]
Time frame: 24 weeks after treatment
Liver function evaluation using Child-Pugh score and MELD score
Time frame: 24 weeks after treatment
Immune function improvement [including Th1/Th2]
Time frame: 24 weeks after treatment
The occurrence of complications [including body temperature, tetter and allergy]
Time frame: Between 0 to 8 hours after UC-MSCs transfusion
Incidence of hepatocellular carcinoma
Time frame: 48 weeks after treatment
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