Clinical trial NCT01724398: Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Liver Failure
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Liver Failure
Keywords: mesenchymal stem cells
plasma exchange
liver failure
hepatitis B virus
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2012-11-09
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival rate and time
timeFrame: 48 weeks
Secondary outcomes:
measure: Improve biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT), INR and so on]
timeFrame: 24 weeks after treatment
measure: The clinical symptom improvement [including appetite, debilitation, abdominal distension, edema of lower limbs, et al]
timeFrame: 24 weeks after treatment
measure: Liver function evaluation using Child-Pugh score and MELD score
timeFrame: 24 weeks after treatment
measure: Immune function improvement [including Th1/Th2]
timeFrame: 24 weeks after treatment
measure: The occurrence of complications [including body temperature, tetter and allergy]
timeFrame: Between 0 to 8 hours after UC-MSCs transfusion
measure: Incidence of hepatocellular carcinoma
timeFrame: 48 weeks after treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Third Affliated Hospital of Sun Yat-sen University
name: Zhi-Liang Gao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.