An open-label, randomized, controlled clinical trial to explore the efficacy and safety of iMSC in preventing the development of acute graft-versus-host disease of degree III-IV in patients after allogeneic hematopoietic stem cell transplantation.
This is an open-label, randomized, controlled study, enrolled subjects(patients at risk for aGVHD of degree III-IV after allogeneic hematopoietic stem cell transplantation) will be 1:1 randomized to experimental group or control group. Control group will receive conventional aGVHD prophylaxis and the experimental group will receive iMSC injection plus conventional aGVHD prophylaxis, with 28 cases in each group, for a total of 56 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
56
1× 10\^6/kg each time, twice a week
Cyclosporine or tacrolimus(CNI)+Mycophenolate mofetil(MMF)± Short Course Methotrexate(MTX)+Anti-human T-lymphocyte Globulin(ATG)
Cumulative incidence of degree III-IV aGvHD
Cumulative incidence of degree III-IV aGvHD at 100 days Within 100 days of first dose
Time frame: Within 100 days of first dose
Cumulative Recurrence Rate (CIR)
Cumulative Recurrence Rate (CIR) at Day 100, Month 6, Month 9, Month 12 , Month 18 , Month 24 after first dose
Time frame: Day 100, Month 6, Month 9, Month 12 , Month 18 , Month 24 after first dose
Disease-free survival (DFS)
DFS at Day 100, Month 6, Month 9, Month 12 , Month 18 , Month 24 after first dose
Time frame: Day 100, Month 6, Month 9, Month 12 , Month 18 , Month 24 after first dose
Adverse Event(AE) or Serious Adverse Event(SAE)
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Time frame: Day 100 after initial infusion
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