drugset / Trial / NCT01844063

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

NCT01844063

Phase 1/2 Unknown 210 enrolled Third Affiliated Hospital, Sun Yat-Sen University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-07
Primary completion
2016-01
Completion
2019-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Mesenchymal stem cell Cell therapy 100000 cells/kg Intravenous
Subject Mesenchymal stem cell Cell therapy 1e+06 cells/kg Intravenous
Subject Mesenchymal stem cell Cell therapy 1e+07 cells/kg Intravenous
Subject human umbilical cord mesenchymal stem cells Cell therapy 100000 cells/kg Intravenous
Subject human umbilical cord mesenchymal stem cells Cell therapy 1e+06 cells/kg Intravenous
Subject human umbilical cord mesenchymal stem cells Cell therapy 1e+07 cells/kg Intravenous
Background Adefovir dipivoxil Small molecule
Background Entecavir Small molecule
Background Lamivudine Other / unclassified
Background Polyene Phosphatidylcholine Small molecule
Background reduced glutathione Unknown

Indications