Safety and Efficacy Investigation of Patients With Liver Cirrhosis by Transplantation of Umbilical Cord Blood Mononuclear Cells
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Liver Cirrhosis
- Sponsor
- Hebei Medical University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- child-pugh classification
- Last Updated
- 12 years ago
Overview
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.
Investigators
Quanhai Li
Director of Cell Thearpy Center, the First Hospital of HeibeiMU
Hebei Medical University
Eligibility Criteria
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
- •Patients with C class by child-pugh score
- •Patients in the acute phase of severe hepatitis
- •Patients have been diagnosed with cancer of the liver
- •Patients with severe cardiopulmonary cerebral disease, and in the failure state
- •Patients in Highly allergic constitution
- •Patients with moderately severe mental disease
Outcomes
Primary Outcomes
child-pugh classification
Time Frame: 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 Outcomes
- vital signs(1, 2 and 3 days after transplantation)
- coagulation(whinin 7 days before transplantation, 1,3,6 months after transplantation)
- mortality(1, 3 and 6 months after transplantation)
- liver function(whinin 7 days before transplantation, 1,3 and 6 months after transplantation)
- incidence of hepatocellular carcinoma(1, 3 and 6 months after transplantation)