Liver Cirrhosis
Conditions
Keywords
liver Cirrhosis, Mesenchymal stem cells, Hepatic artery infusion, Intravenous infusion
Brief summary
The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) transfusion in the treatment of liver cirrhosis. Liver function will be monitored by serum analysis. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA) and albumin (ALB) will be examined at pre-transfusion, and 3 days to 2 years post-transfusion. Child-Pugh scores, Model for End-Stage Liver Disease scores and clinical symptoms will be assessed simultaneously.
Detailed description
Patients with liver cirrhosis will be randomly divided into three groups. Umbilical cord MSCs will be infused to patients using interventional method via hepatic artery for one group. The catheter will be inserted to proper hepatic artery. After the catheter placement confirmed by angiography, umbilical cord MSCs will be infused slowly in 20-30 minutes. Umbilical cord MSCs will be infused intravenously slowly in 30-60 minutes in the intravenous infusion group. The control group will receive conserved therapy. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA)and albumin (ALB) will be examined at re-transplantation, and 3 days to 2 years post-transplantation. The efficacy of umbilical cord MSCs transfusion will be investigated. The efficacy of different interventional therapies will also be compared.
Interventions
Conserved Therapy
PROCEDUREHepatic artery infusion or Intravenous infusion
Patients with liver cirrhosis will be randomly divided into three groups. Umbilical cord MSCs will be infused to patients using interventional method via hepatic artery for one group. The catheter will be inserted to proper hepatic artery. After the catheter placement confirmed by angiography, umbilical cord MSCs will be infused slowly in 20-30 minutes. Umbilical cord MSCs will be infused intravenously slowly for 30-60 minutes in the intravenous infusion group. The control group will receive conserved therapy.
Sponsors
Soochow University
Yufang Shi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-70 years. * Imaging evidences of liver cirrhosis. * Child-Plough score of 8 or more. * Model for End-Stage Liver Disease score of 20 or more.
Exclusion criteria
* Liver tumor on ultrasonography, CT or MRI examination. * Problems in organs other than liver (e.g. heart or lungs). * History of moderate to severe hepatic encephalopathy or variceal bleeding. * Imaging evidences of vascular thromboses. * Coma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 1 year |
| The level of serum alanine aminotransferase (ALT） | 1 year |
| The level of serum total bilirubin (TB) | 1 year |
| The level of serum prothrombin time (PT) | 1 year |
| The level of serum prealbumin(PA) | 1 year |
| The level of serum albumin (ALB) | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| liver biopsy | 2 years |
| Overall survival | 2 years |
| The level of serum alanine aminotransferase (ALT） | 2 years |
| The level of serum total bilirubin (TB) | 2 years |
| The level of serum prothrombin time (PT) | 2 years |
| The level of serum albumin (ALB) | 2 years |
Countries
China
Outcome results
None listed