Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure
Acute-on-chronic liver failure (ACLF) which occurs in patients with chronic liver disease, is a serious live-threatening disease. Currently, the clinical management, such as liver protection, anti-virus medicine, and artificial liver support, has not significantly improve the outcomes, the mortality still remains over 50%. Liver transplantation is the only effective treatment of ACLF, but this therapy is limited by the shortage of donor organs, potential surgical complications, immunological rejection and high medical costs. Mesenchymal stem cell (MSC) is one of adult stem cells, which has been suggested to play a role in amelioration of liver disease, such as: trans-differentiation of MSCs into hepatocytes, immunomodulation, inhibition of fibrosis development, protective effects on hepatic cell and restoration of hepatic cell proliferation capacity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Mesenchymal stem cell transplantation via peripheral vein: 1.0-10x10\^5 MSCs/kg body weight administered via peripheral vein at week 0, 1, 2, 3 weeks
Tianjin Weikai Bioeng., Ltd.
Tianjin, Tianjin Municipality, China
survival rate
Number of participants alive
Time frame: 72 weeks after treatment
Adverse reactions
Number of participants with adverse reactions (e.g. fever, rash, and diarrhea )
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
White blood cell
Change of white blood cell count
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
Platelet
Change of platelet count
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
Hemoglobin
Change of hemoglobin level
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
Creatinine
Change of creatinine level as a surrogate marker of liver function
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
ALT
Change of alanine aminotransferase (ALT) level as a marker of liver function
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
ALB
Change of albumin (ALB) level as a maker of liver function
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
TBil
Change of total Bilirubin (TBil) level as a marker of liver function
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Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
INRs
Change of international normalized ratio (INRs) level as a marker of liver function
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
AFP
Change of alpha fetoprotein (AFP) level as a marker of liver function
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
MELD scores
Model for End-Stage Liver Disease (MELD) score for assessing the severity of chronic liver disease is measured as absolute change to baseline score
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
Tumor formation
Number of participants with hepatocellular carcinoma or extrahepatic malignant tumors
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
Liver failure-associated serious complications
Number of participants with liver failure-associated serious complications, such as infections, encephalopathy, gastrointestinal bleeding and HRS
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48