Safety and Efficacy of Umbilical Cord Mesenchyma Stem Cell Transplantation in Liver Cirrhosis Patients
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- liver volume calculated by MRI
Study Overview
Brief Summary
Mainstream of current treatment of liver cirrhosis is liver transplantation, but there are high cost, risk and immune rejection and other issues. Umbilical cord mesenchyma stem cell with self-and directed differentiation capacity can effectively rescue experimental liver failure and contribute to liver regeneration, which suggests the feasibility of stem cell transplantation therapy. In this study, the safety and efficacy of umbilical cord mesenchyma stem cell transplantation through interventional procedures in patients liver cirrhosis will be evaluated.
Detailed Description
This study included three research centers, each center were carried out 25 cases of liver cirrhosis in patients with stem cell transplantation. All the selection and exclusion criteria are same, data summary and analysis will be complete by the epidemiological commissioner.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of liver cirrhosis;
- •Without hepatic encephalopathy;
- •No ascites or have easily dissipated ascites;
- •Value of bilirubin is less than 100;
- •Value of albumin is greater than 16 g / L;
- •Prothrombin time is less than 21 seconds;
Exclusion Criteria
- •Severe cardiovascular disease, and immunocompromised patients;
- •Patients with localized lesions affecting graft infection;
- •Coagulation disorders;
- •Liver nodules more than 2cm or Liver cancer
Outcomes
Primary Outcomes
liver volume calculated by MRI
Time Frame: 3 days before transplantation, 6 and 12 months after transplantation
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
Secondary Outcomes
- liver biopsy(whinin 7 days before transplantation, 6 and 12 months after transplantation)
- liver enzyme fiber spectrum(whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation)
- portal vein and splenic vein measure(whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation)
- blood biochemistry(whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation)
- coagulation(whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation)
- blood test(whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation)
- gastroscopy(whinin 7 days before transplantation, 6 and 12 months after transplantation)