Trial Information
Clinical Comparison of Safety and Efficacy of Allogeneic Umbilical-Cord and Bone Marrow-derived Mesenchymal Stem Cells Transplantation for HBV-related Liver Failure
Inclusion Criteria:
- Aged 18-65 years
- Liver failure
- Negative pregnancy test (female patients in fertile age)
- Written consent
- HBsAg positive
- TB≥171 μmol/L or ascend ≥17.1 μmol/L/per day,
- INR≥1.5 or 20%<PTA≤40%
- 17≤MELD score≤30
Exclusion Criteria:
- Hepatocellular carcinoma or other malignancies
- Severe problems in other vital organs(e.g.the heart,renal or lungs)
- Pregnant or lactating women
- Severe bacteria infection
- Anticipated with difficulty of follow-up observation
- Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and
so on
- Other candidates who are judged to be not applicable to this study by doctors
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
survival rate
Outcome Description:
The survival rate and time
Outcome Time Frame:
72 weeks
Safety Issue:
No
Principal Investigator
Qi Zhang, Doctor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Third Affiliated Hospital, Sun Yat-Sen University
Authority:
China: Ministry of Health
Study ID:
The Third Affiliated Hospital
NCT ID:
NCT01844063
Start Date:
June 2013
Completion Date:
December 2018
Related Keywords:
- Liver Failure
- Liver Failure