NCT01589549

Mesenchymal Stromal Cells for Acute Graft Versus Host Disease

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: R.P.Herrmann · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Acute GVH Disease

Interventions

Type	Name	Description
BIOLOGICAL	Mesenchymal stromal cell therapy	One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy

Timeline

• Start date: 2012-04-01
• Primary completion: 2015-12-01
• Completion: 2016-12-01
• First posted: 2012-05-02
• Last updated: 2015-06-09

Locations

1 site across 1 country: Australia