Treatment of human umbilical cord-derived mesenchymal stem cells for hepatitis B virus-associated decompensated liver cirrhosis: A clinical trial.

Abstract

Background: Large number of decompensated liver cirrhosis patients in China have been diagnosed with hepatitis B virus (HBV). Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) can possibly cure decompensated liver cirrhosis because of their self-renewal and multidirectional differentiation potential.

Aim: To explore the safety and effect of treating liver cirrhosis with HBV by hUC-MSCs.

Methods: Twenty-four participants were recruited, divided into 3 groups, and injected with different amounts of hUC-MSCs via the peripheral vein. Therapy was administered 3 times. A 24-week follow-up examination of each patient's liver function, coagulation function, general condition, and immune system was performed. Adverse events were also recorded. A 2-year survival assessment was subsequently performed.

Results: Infusion therapy rapidly improved liver function. Serum albumin transiently increased on days 57 and 85 but returned to baseline by day 169, while prothrombin time activity demonstrated sustained improvement from day 29 through day 169. Interleukin-8 levels decreased persistently throughout treatment. All dosage groups achieved 100% 6-month survival; 2-year survival rates were 66.7% (low-dose), 100% (medium-dose), and 87.5% (high-dose). The interaction between dosage and efficacy was weak. Notably, the improvement in liver function was statistically significant and sustained for almost 3 months, suggesting clinically meaningful therapeutic durability.

Conclusion: hUC-MSCs can be considered a safe treatment for patients with decompensated liver cirrhosis associated with HBV. However, larger-scale randomized controlled trials are needed to prove its therapeutic effect.