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.
Subjects with malignant or nonmalignant hematologic diseases 7-21 days after allogeneic hematopoietic stem cell transplantation;
No gender restrictions and age between 14-70 years old；
Patients received aGVHD prophylaxis regimen of a calcium-modulated phosphatase inhibitor combined with mycophenolate mofetil wtih or without short-course methotrexate and rabbit anti-human thymocyte globulin (CNI+MMF± short-course MTX +ATG)；
Patients had a MAGIC algorithm probability (MAP) score ≥ 0.14 at +7d or +14d after allogeneic hematopoietic stem cell transplantation(HSCT) (if patients had a MAP< 0.14 at +7d, another test was performed at +14d)；
Serious organ dysfunction such as organ failure after allogeneic HSCT;
Received more than once HSCT (including autologous transplants);
Positive for Hepatitis B Surface Antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb) and have Hepatitis B Virus (HBV) DNA titers above the normal range ; positive for Hepatitis C Virus (HCV) antibodies and have positive peripheral blood HCV RNA; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for syphilis;
Subjects with severe hepatic veno-occlusive disease or sinus veno-occlusive syndrome;
Parallel
iMSC
Biological/Vaccine1× 10\^6/kg each time, twice a week
conventional aGVHD prophylaxis
Combination productCyclosporine 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
Cumulative Recurrence Rate (CIR)
Cumulative Recurrence Rate (CIR) at 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
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
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