Abstract
BackgroundMesenchymal stem cell (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 understood.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 October 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 survival 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 13 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 HBV-related DLC. UC-MSC medication, therefore, might present a novel therapeutic approach for the disease.Graphic abstract
Highlights
In the past decade, mesenchymal stem cell (MSC) therapies have emerged as a novel alternative for the treatment of endstage liver diseases
These results indicate that the UC-Mesenchymal stem cell (MSC) treatment can significantly increase the survival rate in patients with decompensated liver cirrhosis, the superiority of the umbilical cord-derived MSC (UC-MSC) treatment to the Control (n = 111)
Landmark analysis did not reveal any significant difference in the hepatocellular carcinoma (HCC) disease-free survival rate between the UC-MSC treatment group and control group within 8 months (HR = 1.09, 95% confidence interval (CI) 0.24–4.98, p = 0.907) or between 8 and 75 months (HR = 2.02, 95% CI 0.91–4.47, p = 0.078) (Fig. 5b). These results indicate that the UC-MSC treatment did not pose a higher risk than the conventional treatment in terms of longterm safety for patients with decompensated liver cirrhosis
Summary
Mesenchymal stem cell (MSC) therapies have emerged as a novel alternative for the treatment of endstage liver diseases. Several studies have shown that infusions of autologous BM-MSC can significantly improve liver function in patients with liver cirrhosis [6, 7]. A recent research found that autologous BM-MSC therapy was safe in terms of improving histological fibrosis and liver function in patients with alcoholic cirrhosis [10]. Our previous studies showed that UC-MSC infusion significantly improved liver function in patients with decompensated liver cirrhosis [12] and primary biliary cirrhosis [13] and increased the survival rates of patients with acute-on-chronic liver failure (ACLF) [14]. Conclusions Therapy of UC-MSC is well tolerated, and significantly improves long-term survival rate, as well as the liver function in patients with HBV-related DLC. UC-MSC medication, might present a novel therapeutic approach for the disease
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