Acute GVH Disease Clinical Trial
Official title:
A Phase 2 Trial of Standard of Care Treatment Versus Mesenchymal Stromal Cell Therapy Together With Standard of Care for the Treatment of de Novo Acute Graft Versus Host Disease Following Allogeneic Bone Marrow Transplantation
A randomised study of corticosteroid therapy with or without mesenchymal stromal cell
therapy for newly diagnosed acute graft versus host disease after bone marrow
transplantation or donor lymphocyte therapy.
It is hypothesised that mesenchymal stromal cell therapy will be superior
Patients with newly diagnosed untreated acute graft versus host disease grades 2-4 will receive methylprednisolone 2.5mg/kg intravenously and randomised to receive or not receive allogeneic human mesenchymal stromal cells 2X10E6 intravenously on two occasions at weekly intervals ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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