Efficacy and Safety of UC-MSCs for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT
NCT ID: NCT04738981
Last Updated: 2023-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
130 participants
INTERVENTIONAL
2021-02-01
2023-05-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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UC-MSC and anti-CD25 mAb
UC-MSC, iv, 1×10\^6 cells/kg, once a week, for 4 weeks. Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, 4 weeks. Other treatment would replace it according to clinical experience if aGVHD continue to progress within 3 weeks of treatment or patients are lack of response after 4 weeks of treatment. The treatment would be repeated in another 4 weeks if patients receive partial response after the first 4 weeks of treatment.
UC-MSC
UC-MSC, iv, 1×10\^6 cells/kg, once a week, for 4 weeks.
Anti-CD25 mAb
Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks.
Anti-CD25 mAb
Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks. Other treatment would replace it according to clinical experience if aGVHD continue to progress within 3 weeks of treatment or patients are lack of response after 4 weeks of treatment. The treatment would be repeated in another 4 weeks if patients receive partial response after first 4 weeks of treatment.
Anti-CD25 mAb
Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks.
Interventions
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UC-MSC
UC-MSC, iv, 1×10\^6 cells/kg, once a week, for 4 weeks.
Anti-CD25 mAb
Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6\. Patients who are deemed unsuitable for the study by the investigator.
18 Years
70 Years
ALL
No
Sponsors
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Southern Medical University, China
OTHER
Third Military Medical University
OTHER
Sun Yat-sen University
OTHER
Peking University People's Hospital
OTHER
Responsible Party
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Xiao Hui Zhang
Vice president of Peking Univeristy Institute of Hematology
Principal Investigators
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Xiaohui Zhang, doctor
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital, Peking University Insititute of Hematology
Locations
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Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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References
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Fu H, Sun X, Lin R, Wang Y, Xuan L, Yao H, Zhang Y, Mo X, Lv M, Zheng F, Kong J, Wang F, Yan C, Han T, Chen H, Chen Y, Tang F, Sun Y, Chen Y, Xu L, Liu K, Zhang X, Liu Q, Huang X, Zhang X. Mesenchymal stromal cells plus basiliximab improve the response of steroid-refractory acute graft-versus-host disease as a second-line therapy: a multicentre, randomized, controlled trial. BMC Med. 2024 Feb 27;22(1):85. doi: 10.1186/s12916-024-03275-5.
Other Identifiers
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GVHD-PKU2021
Identifier Type: -
Identifier Source: org_study_id
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