Clinical Trial Of Umbilical Cord Mesenchymal Stem Cells Combined With Bone Marrow Stem Cells Transplantation In Decompensated Cirrhosis.

Aims：To investigate the efficacy and safety of Umbilical cord mesenchymal stemcells combined with bone marrow stem cells transplantation indecompensated cirrhosisMethods：According to the inclusion and exclusion criteria, in total of45decompensated cirrhosis patients were enrolled in this historical prospectivecohort study. There are two groups:17patients with informed consentundergo umbilical cord mesenchymal stem cells combined with bone marrowstem cells transplantation through hepatic artery in the stem cells group,acceptting regular medicine comprehensive treatment at the same time.28patients in the controlled group, accept the regular medicine comprehensivetreatment only. The primary outcome was absolute changes in Child-Pughscore, aminotransferase (ALT), cholinesterase(CHE), albumin(ALB), totalbilirubin (TBIL), prothrombin time (PT), creatinine and Model for End-StageLiver Disease (MELD), one-year survival rate. Secondary outcomes wereabsolute changes in clinical symptoms (appetite, physical power,abdominaldistension or edema, sleep, mental state, daily activity ability), HBV DNA,ascites, adverse reaction related of stem cell therapy. Observe and recordthe change of the patients with primary and secondary outcome in detail inprior treatment (baseline condition),4weeks,12weeks and52weeks aftertreatment.Result: The absolute changes in Child scores, ALT, CHE, ALB, TBIL, PT, Cr, MELDscores, ascites all improve but did not differ significantly between the stemcells group and controlled groups at12months of follow-up (P>0.05). At the4weeks after treatment, the clinical symptoms in stem cells group were significantly improved, compared with the controlled group(P<0.05), but atthe12weeks and52weeks after treatment. No difference between the twogroups of year survival rate. No adverse reaction related of stem cell therapywas observed for one year follow-up.Conclusion:Umbilical cord mesenchymal stem cells combined with bone marrowstem cells transplantation in decompensated cirrhosis is safe and may improvethe patient’s quality of life．Further studies with higher number of patients arewarranted to better clarify the impact of MSC infusion.