Clinical Trial: Mesenchymal Stromal Cells for Acute Graft Versus Host Disease
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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<
Brief Summary:
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
Detailed Summary: 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
Sponsor: R.P.Herrmann
Current Primary Outcome: Survival at one year after onset of graft versus host disease [ Time Frame: One year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Royal Perth Hospital
Dates:
Date Received: April 26, 2012
Date Started: April 2012
Date Completion: December 2016
Last Updated: June 8, 2015
Last Verified: June 2015
