A Study of iMSC for the Prevention of Acute Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
NCT06949267 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2025-04-29
Summary
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.
Conditions
- Acute Graft-versus-Host Disease
Interventions
- BIOLOGICAL
-
iMSC
1× 10\^6/kg each time, twice a week
- COMBINATION_PRODUCT
-
conventional aGVHD prophylaxis
Cyclosporine or tacrolimus(CNI)+Mycophenolate mofetil(MMF)± Short Course Methotrexate(MTX)+Anti-human T-lymphocyte Globulin(ATG)
Sponsors & Collaborators
-
Ruijin Hospital
lead OTHER
Principal Investigators
-
Xiaoxia Hu, MD · Ruijin Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 14 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-01
- Primary Completion
- 2026-09-30
- Completion
- 2028-03-31
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