Safety and Efficacy of Diverse Mesenchymal Stem Cells Transplantation for Liver Failure

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

HBV-related liver failure (HBV-LF), a dramatic clinical syndrome, is characterized with massive necrosis of liver cells. Liver transplantation might be the most effective therapy for HBV-LF. However, there are a lot of problems such as lack of donors, surgical complications, transplant rejection, and high cost, which could limit the application of liver transplantation. It is demonstrated that mesenchymal stem cells could directionally differentiate into hepatocytes and cholangiocytes in injured liver, as well as reduce inflammation of the liver by immune regulation. In this study, we assess the safety and efficacy of human bone marrow and umbilical cord mesenchymal stem cells transplantation for patients with HBV-LF.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Treatments: Antiviral Agents

Criteria

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%- 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