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| Name | Class |
|---|---|
| Southern Medical University, China | OTHER |
| Third Military Medical University | OTHER |
| Sun Yat-sen University | OTHER |
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Randomized, open-label, multicenter study to investigate the efficacy and safety of umbilical cord-derived mesenchymal stem cells (UC-MSC) for the treatment of steroid-resistant acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a view to establishing an effective treatment protocol for steroid-resistant aGVHD.
A total of 130 patients with steroid-resistant aGVHD after allo-HSCT are enrolled in this multicenter, randomized, controlled trial. Patients were randomized to UC-MSC + anti-CD25 monoclonal antibodies (mAb) group and anti-CD25 mAb group. The complete response (CR) rate after 4 weeks of treatment in the two groups will be compared. Adverse events are also recorded throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC-MSC and anti-CD25 mAb | Experimental | 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. |
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| Anti-CD25 mAb | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UC-MSC | Drug | UC-MSC, iv, 1×10^6 cells/kg, once a week, for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete remission | Complete remission of aGVHD related symptoms and indicators | 4 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The time from randomization to death for any reason ( the last follow-up time for missing patients; end date of follow-up for patients who are live at the end of the study). | At the end of Week 4 / 8 / 12 / 24 / 52. |
| Rate of partial remission |
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Inclusion Criteria:
Exclusion Criteria:
- 1. Untoleratation of the treatment. 2. Primary disease are not effectively controlled or are progressing. 3. Active infection (Bacteria, fungi, viruses ). 4. Combined with dysfunction of multiple organ. 5. Female patients who are nursing or pregnant, or who contemplate pregnancy during the study period.
6. Patients who are deemed unsuitable for the study by the investigator.
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| Name | Affiliation | Role |
|---|---|---|
| Xiaohui Zhang, doctor | Peking University People's Hospital, Peking University Insititute of Hematology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Insititute of Hematology, Peking University People's Hospital | Beijing | Beijing Municipality | 100010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38413930 | Derived | 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. |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C584092 | PC61 monoclonal antibody |
| D000077552 | Basiliximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Anti-CD25 mAb | Drug | Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks. |
|
|
improvement of aGVHD staging in one or more organs without progression in other organs |
| 4 weeks after treatment |
| Infusion toxicity | Acute toxicity responses include impaired function of heart, kidney and liver | From the beginning of to four hours after every infusion of UC-MSC |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |