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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
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, for 4 weeks.
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China
Rate of complete remission
Complete remission of aGVHD related symptoms and indicators
Time frame: 4 weeks after treatment
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).
Time frame: At the end of Week 4 / 8 / 12 / 24 / 52.
Rate of partial remission
improvement of aGVHD staging in one or more organs without progression in other organs
Time frame: 4 weeks after treatment
Infusion toxicity
Acute toxicity responses include impaired function of heart, kidney and liver
Time frame: From the beginning of to four hours after every infusion of UC-MSC
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