Mesenchymal Stromal Cells for Acute Graft Versus Host Disease

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Acute GVH Disease

Intervention / Treatment
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* Biological: Mesenchymal stromal cell therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Grades 2-4 acute graft versus host disease after bone marrow transplantation up to day +180 after transplantation Age 18-55 years Must be receiving a calcineurin inhibitor Exclusion Criteria: Failure to sign informed consent Corticosteroid therapy for 72 hours or greater ECOG score equal to or greater than 3

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stromal cell therapy<br>Mesenchymal stromal cell therapy in addition to corticosteroid therapy | Biological: Mesenchymal stromal cell therapy<br>* One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy<br>* Other names: Mesenchymal stem cells;|
| Active Comparator: Corticosteroid therapy<br> | Biological: Mesenchymal stromal cell therapy<br>* One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy<br>* Other names: Mesenchymal stem cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival at one year after onset of graft versus host disease |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response at 14 days after commencement of treatment for acute graft versus host disease |  | 14 days | 
| Response at 28 days after commencement of treatment of acute graft versus host disease |  | 28 days | 
| Incidence of severe infection |  | One year | 
| Disease free survival at one year |  | One year | 
| Time to treatment failure, requiring salvage therapy |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute graft versus host disease, Bone marrow transplantation, Mesenchymal stromal cells