Mesenchymal Stem Cell Therapy in Decompensated Liver Cirrhosis: A Long-Term Follow-up Analysis of the Randomized Controlled Clinical Trial
BackgroundMesenchymal stem cells (MSC) infusion was reported to improve liver function in patients with decompensated liver cirrhosis (DLC), however, whether the medication can improve outcome of these patients is poorly understand.MethodsThis prospective, open-labeled, randomized controlled study enrolled 219 patients with HBV-related DLC who were divided into control group (n=111) and umbilical cord-derived MSC (UC-MSC) treated group (n=108), then all of them received a follow-up check from
... tober 2010 to October 2017. The treated patients received three times of UC-MSC infusions at 4-week intervals plus conventional treatment that was only used for control group. The overall survival rate and HCC-free survial rate were calculated as primary endpoints and the liver function and adverse events associated with the medication were also evaluated.ResultsDuring the follow-up check period from 13th to 75th months, there was a significantly higher overall survival rate in the treated group than the control group, while the difference of the hepatocellular carcinoma event-free survival rate between the treated and control groups was not observed during the 75-month follow-up. UC-MSC treatment markedly improved liver function, as indicated by the levels of serum albumin, prothrombin activity, cholinesterase, and total bilirubin during 48 weeks of follow-up. No significant side effects or treatment-related complications were observed in the UC-MSC group.ConclusionsTherapy of UC-MSC is not only well tolerated, but also significantly improves long-term survival rate, as well as the liver function in patients with DLC. UC-MSC medication, therefore, might present a novel therapeutic approach for the disease.