BACKGROUND: Cirrhosis, the end stage of progressive hepatic fibrosis, is characterized by distortion of the hepatic architecture and the formation of regenerative nodules. Liver transplantation is one of the few available therapies for such patients. However, due to a severe shortage of organ donors, surgical complications, transplant rejection and the high cost of this procedure much interest has focused on research to find new treatment modalities for this disease. There is accumulating evidence for the contribution of bone marrow stem cells to participate in liver regeneration. METHODS: Here we report on six patients with end stage liver disease who were subjected tointraportal administration of autologous bone marrow-derived CD133(+) in comparison to mononuclear cells in short-term (6 months) and long-term (24 months) follow up. RESULTS: There were no adverse effects in any of the patients during the short- and long-term follow up period. Moreover, there were no significant alterations of liver function parameters, liver enzymes, serum albumin, creatinine, serum bilirubin and/orliver volume after transplantation of both types of autologous cells in these patients. CONCLUSION: Our study has shown both the safety and feasibility of this type of liver cell therapy and may be a bridge to liver transplantation. The trial was registered with NIH clinical trials (www.clinicaltrials.gov) as identifier: NCT00713934.
RCT Entities:
BACKGROUND:Cirrhosis, the end stage of progressive hepatic fibrosis, is characterized by distortion of the hepatic architecture and the formation of regenerative nodules. Liver transplantation is one of the few available therapies for such patients. However, due to a severe shortage of organ donors, surgical complications, transplant rejection and the high cost of this procedure much interest has focused on research to find new treatment modalities for this disease. There is accumulating evidence for the contribution of bone marrow stem cells to participate in liver regeneration. METHODS: Here we report on six patients with end stage liver disease who were subjected to intraportal administration of autologous bone marrow-derived CD133(+) in comparison to mononuclear cells in short-term (6 months) and long-term (24 months) follow up. RESULTS: There were no adverse effects in any of the patients during the short- and long-term follow up period. Moreover, there were no significant alterations of liver function parameters, liver enzymes, serum albumin, creatinine, serum bilirubin and/or liver volume after transplantation of both types of autologous cells in these patients. CONCLUSION: Our study has shown both the safety and feasibility of this type of liver cell therapy and may be a bridge to liver transplantation. The trial was registered with NIH clinical trials (www.clinicaltrials.gov) as identifier: NCT00713934.