The research of human umbilical cord mesenchymal stem cells therapy in decompensated liver cirrhosis associated with hepatitis virus B: a long-term follow up analysis of a single-center, on-limits and stepped research.

Abstract

Abstract Background: There is a large number of decompensated liver cirrhosis patients in China, caused by infection of hepatitis B virus(HBV) mainly. These patient suffered a process of irreversible liver cirrhosis. Umbilical cord-derived mesenchymal stem cells (UC-MSCs) has the potential of self-renewal and multidirectional differentiation, which makes it possible for curing decompensated liver cirrhosis. Methods: 24 participants was recruited and divided into 3 groups. hUC-MSCs would be infused via peripheral vein 3 times. A 24 weeks follow up visit would be proceeded, including detecting liver function, coagulation function, general condition, immune system etc. Adverse event also would be recorded. A 1.5 year visit of survival would be proceeded subsequently. Results: After infusion, liver function was improved in a short time. ALB increased in 57th and 85th day, but descended to baseline level in 169th day. PTTA was significantly improved since 29th day till 157th day. IL-8 was decreased during the whole visit. AE of class 1 and 2 were over 70%, while SAE occurred only 3 times. The 6-month survival rate is 75%, 75%, 100% in low, medium, high dose group. The interaction between dosage and efficacy is weak. Conclusion: hUC-MSCs has great potential for treating patients of decompensated liver cirrhosis associated with HBV, with satisfied safety. The large sample size and RCT trial is required to prove its therapeutic effect. Trial registration: This trial was registered in clinicaltrials.gov and the registration ID is NCT05442437. The name of registry is “Clinical Study of hUC-MSCs Treating Decompensated Liver Cirrhosis With HBV”. The registry published in 1st of July,2022.