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©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
Treatment of human umbilical cord-derived mesenchymal stem cells for hepatitis B virus-associated decompensated liver cirrhosis: A clinical trial
Xian Qin, Jing Chen, Hua-Ni Zhang, Li Du, Yan Ma, Yi Li, Yu Lu, Ya-Ting Wang, Liu-Fang Wu, Zi-Hui Yu, Meng-Jing Hu, Li-Jun Li, Bo Liao, Zhen Li, Zhi-Yong Yang, Kun Li, Yu-Feng Yuan
Xian Qin, Li Du, Yan Ma, Yi Li, Yu Lu, Ya-Ting Wang, Liu-Fang Wu, Zi-Hui Yu, Meng-Jing Hu, Bo Liao, Zhen Li, Zhi-Yong Yang, Kun Li, Yu-Feng Yuan, Department of Hepatobiliary and Pancreatic Surgery, Zhongnan Hospital of Wuhan University, Wuhan 430000, Hubei Province, China
Jing Chen, Li-Jun Li, Department of Internal Medicine and Geriatrics, Zhongnan Hospital of Wuhan University, Wuhan 430000, Hubei Province, China
Hua-Ni Zhang, Hubei Provincial Clinical Research Center for Umbilical Cord Blood Hematopoietic Stem Cells, Taihe Hospital, Hubei University of Medicine, Shiyan 442000, Hubei Province, China
Hua-Ni Zhang, Department of Pharmacy, Shiyan Hospital of Integrated Traditional Chinese and Western Medicine, Shiyan 442000, Hubei Province, China
Zhi-Yong Yang, Pancreatic Surgery Center, Clinical Medicine Research Center for Minimally Invasive Procedure of Hepatobiliary and Pancreatic Diseases of Hubei Province, Zhongnan Hospital of Wuhan University, Wuhan 430071, Hubei Province, China
Co-first authors: Xian Qin and Jing Chen.
Co-corresponding authors: Kun Li and Yu-Feng Yuan.
Author contributions: Qin X performed the research, managed follow-up visits, and drafted the manuscript; Chen J performed statistical analysis, created figures and tables; Qin X and Chen J contributed equally to this article, they are the co-first authors of this manuscript; Qin X and Zhang HN collected and analyzed data; Du L, Ma Y, Li Y, Lu Y, Wang YT, Wu LF, Yu ZH, Hu MJ, and Li LJ administered infusions, monitored participants, recorded adverse events; Liao B and Li Z monitored post-infusion participants and recorded clinical features; Yang ZY coordinated interdepartmental examinations for trial implementation; Li K supervised trial procedures, reviewed medical records; Yuan YF designed the study, supervised all trial activities, revised the manuscript, and audited statistical analyses; Li K and Yuan YF contributed equally to this article, they are the co-corresponding authors of this manuscript; and all authors reviewed and approved the final manuscript.
Supported by the Foundation of Health Commission of Hubei Province, No. WJ2019H053; Natural Science Foundation of Hubei Province, No. 2023AFB169; Foundation of Health Commission of Hubei Province, No. ZY2021Q019; and Open Fund Hubei Provincial Clinical Research Center for Umbilical Cord Blood Hematopoietic Stem Cells, Taihe Hospital, No. 2024SCOF008.
Institutional review board statement: This study was approved by the Medical Ethics Committee of Zhongnan Hospital of Wuhan University, approval No.[2018] 001.
Informed consent statement: All participants or their legal guardian of this clinical trial have provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: No additional data are available.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Yu-Feng Yuan, MD, Professor, Department of Hepatobiliary and Pancreatic Surgery, Zhongnan Hospital of Wuhan University, No. 169 Donghu Road, Wuchang District, Wuhan 430000, Hubei Province, China.
yuanyf1971@whu.edu.cn
Received: May 27, 2025
Revised: June 25, 2025
Accepted: July 28, 2025
Published online: September 27, 2025
Processing time: 120 Days and 17.1 Hours
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.
Core Tip: This pioneering trial demonstrates that peripheral vein infusion of human umbilical cord-derived mesenchymal stem cells provides rapid and durable liver function improvement in HBV-related decompensated cirrhosis. Key results include: (1) Improvement in liver function sustained for almost 3 months; (2) Coagulation improvement and interleukin-8 reduction sustained > 3 months; (3) 100% 6-month survival across all doses and exceptional 2-year survival (66.7%-100%); (4) Weak dose-efficacy correlation suggesting even low-dose efficacy; and (5) Promising safety profile. human umbilical cord-derived mesenchymal stem cells represent a novel therapy for end-stage liver disease, warranting large-scale validation.
