Liver Failure
Conditions
Keywords
mesenchymal stem cells, plasma exchange, liver failure, hepatitis B virus
Brief summary
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.
Detailed description
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.
Interventions
Received conventional treatment and umbilical cord mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×105/Kg, once a week, 4 times).
OTHERConventional plus PE treatment
Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times).
OTHERConventional plus UC-MSC and PE therapy
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.
OTHERConventional treatment
Received conventional treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rate and time | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Immune function improvement [including Th1/Th2] | 24 weeks after treatment |
| The occurrence of complications [including body temperature, tetter and allergy] | Between 0 to 8 hours after UC-MSCs transfusion |
| Liver function evaluation using Child-Pugh score and MELD score | 24 weeks after treatment |
| The clinical symptom improvement [including appetite, debilitation, abdominal distension, edema of lower limbs, et al] | 24 weeks after treatment |
| Incidence of hepatocellular carcinoma | 48 weeks after treatment |
| Improve biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT), INR and so on] | 24 weeks after treatment |
Countries
China
Contacts
Primary ContactZhi-Liang Gao, Professor
Backup ContactHong-Liang He, Master
Outcome results
None listed