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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy
Royal Perth Hospital
Perth, Western Australia, Australia
RECRUITINGSurvival at one year after onset of graft versus host disease
Time frame: One year
Response at 14 days after commencement of treatment for acute graft versus host disease
Time frame: 14 days
Response at 28 days after commencement of treatment of acute graft versus host disease
Time frame: 28 days
Incidence of severe infection
Time frame: One year
Disease free survival at one year
Time frame: One year
Time to treatment failure, requiring salvage therapy
Time frame: 28 days
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