Global clinical trials on stem cell therapy for autoimmune diseases: trends and future directions
BackgroundAutoimmune 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 emerg...
Saved in:
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2025-07-01
|
| Series: | Frontiers in Immunology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fimmu.2025.1616231/full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849303603418759168 |
|---|---|
| author | Yanhao Chen Xiang Li Jiao Zhang Jiaqi Peng Fugang Huang Jie Bao Yongsheng Fan Shuo Huang |
| author_facet | Yanhao Chen Xiang Li Jiao Zhang Jiaqi Peng Fugang Huang Jie Bao Yongsheng Fan Shuo Huang |
| author_sort | Yanhao Chen |
| collection | DOAJ |
| description | BackgroundAutoimmune 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.MethodsClinical trial data (2006–2025) 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.ResultsOf 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 49.2% of trials. Key therapeutic strategies included immune modulation, tissue repair via growth factors, and anti-infection/anti-proliferative effects. Disease-specific variations were noted in cell sources and administration routes.ConclusionStem 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. |
| format | Article |
| id | doaj-art-9f2f5c7447334f2d8c5d9e6e89ad88c1 |
| institution | Kabale University |
| issn | 1664-3224 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Immunology |
| spelling | doaj-art-9f2f5c7447334f2d8c5d9e6e89ad88c12025-08-20T03:56:03ZengFrontiers Media S.A.Frontiers in Immunology1664-32242025-07-011610.3389/fimmu.2025.16162311616231Global clinical trials on stem cell therapy for autoimmune diseases: trends and future directionsYanhao Chen0Xiang Li1Jiao Zhang2Jiaqi Peng3Fugang Huang4Jie Bao5Yongsheng Fan6Shuo Huang7The Second School of Clinical Medicine, Zhejiang Chinese Medical University, Hangzhou, ChinaThe Second School of Clinical Medicine, Zhejiang Chinese Medical University, Hangzhou, ChinaSchool of Basic Medical Sciences, Zhejiang University of Chinese Medicine, Hangzhou, ChinaSchool of Basic Medical Sciences, Zhejiang University of Chinese Medicine, Hangzhou, ChinaThe Second School of Clinical Medicine, Zhejiang Chinese Medical University, Hangzhou, ChinaSchool of Basic Medical Sciences, Zhejiang University of Chinese Medicine, Hangzhou, ChinaThe Second Affiliated Hospital of Zhejiang Chinese Medical University (Xinhua Hospital of Zhejiang Province), Hangzhou, ChinaSchool of Basic Medical Sciences, Zhejiang University of Chinese Medicine, Hangzhou, ChinaBackgroundAutoimmune 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.MethodsClinical trial data (2006–2025) 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.ResultsOf 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 49.2% of trials. Key therapeutic strategies included immune modulation, tissue repair via growth factors, and anti-infection/anti-proliferative effects. Disease-specific variations were noted in cell sources and administration routes.ConclusionStem 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.https://www.frontiersin.org/articles/10.3389/fimmu.2025.1616231/fullautoimmune diseasesclinical trialsCrohn’s diseasemesenchymal stem cellsstem cell therapy |
| spellingShingle | Yanhao Chen Xiang Li Jiao Zhang Jiaqi Peng Fugang Huang Jie Bao Yongsheng Fan Shuo Huang Global clinical trials on stem cell therapy for autoimmune diseases: trends and future directions Frontiers in Immunology autoimmune diseases clinical trials Crohn’s disease mesenchymal stem cells stem cell therapy |
| title | Global clinical trials on stem cell therapy for autoimmune diseases: trends and future directions |
| title_full | Global clinical trials on stem cell therapy for autoimmune diseases: trends and future directions |
| title_fullStr | Global clinical trials on stem cell therapy for autoimmune diseases: trends and future directions |
| title_full_unstemmed | Global clinical trials on stem cell therapy for autoimmune diseases: trends and future directions |
| title_short | Global clinical trials on stem cell therapy for autoimmune diseases: trends and future directions |
| title_sort | global clinical trials on stem cell therapy for autoimmune diseases trends and future directions |
| topic | autoimmune diseases clinical trials Crohn’s disease mesenchymal stem cells stem cell therapy |
| url | https://www.frontiersin.org/articles/10.3389/fimmu.2025.1616231/full |
| work_keys_str_mv | AT yanhaochen globalclinicaltrialsonstemcelltherapyforautoimmunediseasestrendsandfuturedirections AT xiangli globalclinicaltrialsonstemcelltherapyforautoimmunediseasestrendsandfuturedirections AT jiaozhang globalclinicaltrialsonstemcelltherapyforautoimmunediseasestrendsandfuturedirections AT jiaqipeng globalclinicaltrialsonstemcelltherapyforautoimmunediseasestrendsandfuturedirections AT fuganghuang globalclinicaltrialsonstemcelltherapyforautoimmunediseasestrendsandfuturedirections AT jiebao globalclinicaltrialsonstemcelltherapyforautoimmunediseasestrendsandfuturedirections AT yongshengfan globalclinicaltrialsonstemcelltherapyforautoimmunediseasestrendsandfuturedirections AT shuohuang globalclinicaltrialsonstemcelltherapyforautoimmunediseasestrendsandfuturedirections |