SYSTEMATIC REVIEW article
Front. Immunol.
Sec. Autoimmune and Autoinflammatory Disorders : Autoimmune Disorders
Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1616231
Global Clinical Trials on Stem Cell Therapy for Autoimmune Diseases: Trends and Future Directions
Provisionally accepted
- 1Second Clinical Medical School, Zhejiang Chinese Medical University, Hangzhou, Jiangsu Province, China
- 2School of Basic Medical Sciences, Zhejiang University of Chinese Medicine, Hangzhou, China
- 3Second Affiliated Hospital, Zhejiang Chinese Medical University, Hangzhou, Zhejiang Province, China
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Background: Autoimmune diseases, such as Crohn's disease (CD) and systemic lupus erythematosus (SLE), lead to progressive multi-organ damage due to immune dysregulation and chronic inflammation. Current therapies lack efficacy and safety, often failing to sustain remission. Stem cell therapy has emerged as a promising approach for immune modulation and tissue repair. This study analyzes clinical trial trends and challenges of stem cell therapy in autoimmune diseases.Methods: Clinical trial data (2006)(2007)(2008)(2009)(2010)(2011)(2012)(2013)(2014)(2015)(2016)(2017)(2018)(2019)(2020)(2021)(2022)(2023)(2024)(2025) were extracted from Trialtrove. Strict inclusion criteria were applied, restricting the analysis to interventional trials while excluding observational studies, non-autoimmune disease trials, and records with incomplete information. Descriptive statistics were used to analyze trial phases, disease types, geographic distribution, funding sources, therapeutic mechanisms, and stem cell sources, followed by a comparative evaluation of therapeutic efficacy, combination strategies, and safety profiles across autoimmune indications.Results: Of the 1,511 global trials, 244 were included after screening and cross-referencing. Most trials (83.6%) were in Phase I-II. CD (n=85), SLE (n=36), and scleroderma (n=32) were the most studied. The U.S. and China led in trial numbers. Academic institutions funded 48.1% of trials. Key therapeutic strategies included immune modulation, tissue repair via growth factors, and antiinfection/anti-proliferative effects. Disease-specific variations were noted in cell sources and administration routes. Conclusion: Stem cell therapy holds substantial promise for autoimmune disease treatment. Future efforts should prioritize technological innovation, international collaboration, and precision medicine to address current challenges and advance clinical translation.
Keywords: Autoimmune Diseases, clinical trials, Crohn's disease, Mesenchymal Stem Cells, Stem Cell Therapy
Received: 22 Apr 2025; Accepted: 10 Jul 2025.
Copyright: © 2025 Chen, Li, Zhang, Peng, Huang, Bao, Fan and Huang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Yongsheng Fan, Second Affiliated Hospital, Zhejiang Chinese Medical University, Hangzhou, 310005, Zhejiang Province, China
Shuo Huang, School of Basic Medical Sciences, Zhejiang University of Chinese Medicine, Hangzhou, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.