Phase 1 trial of autologous bone marrow mesenchymal stem cell transplantation in patients with decompensated liver cirrhosis.

BACKGROUND The standard treatment for decompensated liver cirrhosis is liver transplantation. However, it has several limitations. Recent animal studies suggest that bone marrow stem cell transplantation can lead to regression of liver fibrosis. The objective of this study was to determine the safety and feasibility of autologous bone marrow-mesenchymal stem cell transplantation in patients with decompensated liver cirrhosis. METHODS In this phase 1 trial, four patients with decompensated liver cirrhosis were included. Their bone marrow was aspirated, mesenchymal stem cells were cultured, and a mean 31.73 x 10(6) mesenchymal stem cells were infused through a peripheral vein. Primary outcomes were evaluating the safety and feasibility of the work. Secondary outcomes were evaluating changes in the model for end-stage liver disease score, and the quality of life of the patients. RESULTS There were no side-effects in the patients during follow-up. The model for end-stage liver disease scores of patients 1, and 4 improved by four and three points, respectively by the end of follow-up. Furthermore, the quality of life of all four patients improved by the end of follow-up. Using SF-36 questionnaire, the mean physical component scale increased from 31.44 to 65.19, and the mean mental component scale increased from 36.32 to 65.55. CONCLUSION Mesenchymal stem cell transplantation seems to be feasible and safe in the treatment of decompensated liver cirrhosis.