Liver Cirrhosis
Conditions
Brief summary
This study is to evaluate the safety and efficacy of umbilical cord blood mononuclear cells transplantation in liver cirrhosis patients.
Detailed description
Decompensated liver cirrhosis (LC), a life-threatening complication of chronic liver disease, is one of the major indications for liver transplantation. Recently, umbilical cord blood mononuclear cells transfusion has been shown to lead to the regression of liver fibrosis in animal model. The investigators thus investigated the safety of the therapy with life signs like temperature, pulse, blood pressure, the incidence of hepatocellular carcinoma and mortality and so on. And the efficacy was evaluated with the measurement of alanine aminotransferase (ALT), glutamic oxaloacetic transaminase (AST), total bilirubin (TBIL), direct bilirubin (DBIL), albumin (ALB), cholinesterase (CHE), prothrombin time (PT) and child-pugh score.
Interventions
BIOLOGICALUmbilical Cord Blood Mononuclear Cells
Participants will be transplanted with umbilical cord blood mononuclear cells.
Sponsors
Hebei Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with hepatocirrhosis: according to the standard of child- pugh, liver functions to achieve class A or B patients, Including C class patients but can achieve B class after treatment
Exclusion criteria
1. Patients with C class by child-pugh score 2. Patients in the acute phase of severe hepatitis 3. Patients have been diagnosed with cancer of the liver 4. Patients with severe cardiopulmonary cerebral disease, and in the failure state 5. Patients in Highly allergic constitution 6. Patients with moderately severe mental disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| child-pugh classification | whinin 7 days before transplantation, 1,3 and 6 months after transplantation | 1. child-pugh A (child-pugh score 5-6) 2. child-pugh B (child-pugh score 7-9) 3. child-pugh C (child-pugh score≥10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| coagulation | whinin 7 days before transplantation, 1,3,6 months after transplantation | 1. prothrombin time (PT) 2. activated partial thromboplastin time (APTT) 3. fibrinogen (FIB) |
| liver function | whinin 7 days before transplantation, 1,3 and 6 months after transplantation | 1. alanine aminotransferase (ALT) 2. aspartate aminotransferase (AST) 3. total bilirubin （TBIL） 4. direct bilirubin (DBIL) 5. serum cholinesterase (CHE) 6. albumin (ALB) |
| vital signs | 1, 2 and 3 days after transplantation | 1. temperature 2. pulse 3. blood pressure |
| incidence of hepatocellular carcinoma | 1, 3 and 6 months after transplantation | — |
| mortality | 1, 3 and 6 months after transplantation | — |
Countries
China
Outcome results
None listed