Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Efficacy and Safety of UC-MSCS for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT: A Multicenter, Randomized, Open-label Trial

ID
Name
GVHD-PKU2021
Description
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.
Trial arms
Trial start
2021-02-01
Estimated PCD
2022-05-30
Trial end
2023-05-02
Status
Completed
Phase
Early phase I
Treatment
UC-MSC
UC-MSC, iv, 1×10\^6 cells/kg, once a week, for 4 weeks.
Arms:
UC-MSC and anti-CD25 mAb
Other names:
Umbilical cord-derived mesenchymal stem cells
Anti-CD25 mAb
Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks.
Arms:
Anti-CD25 mAb, UC-MSC and anti-CD25 mAb
Other names:
Basiliximab
Size
130
Primary endpoint
Rate of complete remission
4 weeks after treatment
Eligibility criteria
Inclusion Criteria: * 1.Confirmed diagnosed steroid-resistant aGVHD after allo-HSCT. 2. Neutrophile granulocyte (ANC) ≥ 0.5 x 10\^9/L. 3. Creatinine below 2 times normal upper limit . 4. Willing and able to sign written informed consent. 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 130, 'type': 'ACTUAL'}}
Updated at
2023-06-01

1 organization

2 products

1 indication

Organization
Peking University People's Hospital
Product
UC-MSC
Indication
Graft-Vs-Host Disease
Product
Anti-CD25 mAb