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Authors
Zheng, Yawei
Wang, Lu
Mo, Xiaodong
Zhang, Yuanyuan
Li, Yuhang
Han, Mingzhe
Yang, Donglin
Zhang, Xiaohui
Liu, Daihong
Jiang, Erlie
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Clinical Trials BETA
Clinical trials referenced in this document:
chictr2300073965 at Chinese Clinical Trial RegistryDocuments that mention this clinical trial
Mesenchymal stromal cells as add-on therapy to anti-CD25 antibodies for treating gastrointestinal-involved steroid-refractory acute graft-versus-host disease: a multicenter, single-arm, pivotal clinical trial
https://doi.org/10.1186/s13287-026-04982-x
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Funding
Funding for this research was provided by:
the CAMS Innovation Fund for Medical Sciences, CIFMS (2023-I2M-C&T-B-108)
the CAMS Innovation Fund for Medical Sciences, CIFMS (2023-I2M-2-007)
Noncommunicable Chronic Diseases-National Science and Technology Major Project (2023ZD0502400)
the National Natural Science Foundation of China (82070192)
Haihe Laboratory of Cell Ecosystem Innovation Fund (22HHXBSS00034)
Tianjin Natural Science Foundation (23JCZXJC00220)
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Article History
Received: 31 October 2025
Accepted: 13 March 2026
First Online: 24 March 2026
Declarations
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: This study involving human umbilical cord–derived mesenchymal stromal cells (hUC-MSCs) was conducted in accordance with the Declaration of Helsinki. The study protocol, informed consent form (ICF), and all relevant documents were reviewed and approved by the ethics committees of all participating centers. Written informed consent for participation in the study and the use of clinical data and samples was obtained from all patients or their legal guardians/legally authorised representatives. The following ethics approvals were obtained: (1) Title: To evaluate the therapeutic effect of hUC-MSC PLEB001 in Steroid-Refractory acute graft versus host disease (aGVHD): a multicenter, single arm, pivotal clinical trial. Committee: Ethics Committee of the First Medical Center of the Chinese People’s Liberation Army General Hospital. Approval number: C2022-059-02. Date of approval: 17 February 2023. (2) Title: To evaluate the therapeutic effect of hUC-MSC PLEB001 in Steroid-Refractory acute graft versus host disease (aGVHD): a multicenter, single arm, pivotal clinical trial. Committee: Ethics Committee of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences. Approval number: XY2022083-EC-1. Date of approval: 24 February 2023. (3) Title: To evaluate the therapeutic effect of hUC-MSC PLEB001 in Steroid-Refractory acute graft versus host disease (aGVHD): a multicenter, single arm, pivotal clinical trial. Committee: Ethics Committee of the Fifth Medical Center of the Chinese People’s Liberation Army General Hospital. Approval number: 2023-2-5-1. Date of approval: 1 March 2023. (4) Title: To evaluate the therapeutic effect of hUC-MSC PLEB001 in Steroid-Refractory acute graft versus host disease (aGVHD): a multicenter, single arm, pivotal clinical trial. Committee: Ethics Committee of Peking University People’s Hospital. Approval number: 2023PHC039-001. Date of approval: 6 September 2023.
: Not applicable.
: The authors declare no competing interests.
