Decidual Stromal Cells as Treatment for Acute Graft Versus Host Disease, a Phase 1-2 Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate safety and efficacy using decidual stromal cell therapy for graft versus host disease after allogeneic hematopoietic stem cell transplantation. The hypothesis to be tested is that the cells are safe to infuse and that they have a positive clinical effect.

Detailed Description
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Patients with GVHD grade 2-4, will receive decidual stromal cells at approximately 1-2x10^6 cells/kg at one or more occasions dependent on clinical response.

Official Title
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Decidual Stromal Cells as Treatment for Acute Graft Versus Host Disease

Conditions
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Graft vs Host Disease

Intervention / Treatment
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* Biological: Decidual Stromal Cells thawed in plasma
* Biological: Decidual Stromal Cells thawed in human albumin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute graft versus host disease grade 2-4. Are on calcineurin inhibitor and high dose corticosteroids. Exclusion Criteria: None.
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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decidual Stromal Cells as last line treatment<br>Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids without any signs of improvement will be given DSCs to evaluate a possible effect. DSCs will be thawed from the freezer in plasma. | Biological: Decidual Stromal Cells thawed in plasma<br> <br> |
| Active Comparator: Decidual Stromal Cells<br>Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids will be given DSCs as early as possible at one or more occasions at weekly intervals dependent on clinical response. DSCs will be thawed from the freezer in plasma. | Biological: Decidual Stromal Cells thawed in human albumin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actuarial survival at six months after first DSC infusion |  | 6 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response at 28 days after onset of graft versus host disease | Response will be measured as: Partial response (PR) if the patient has improved one grade in the overall GvH. Complete response (CR) if the patient is free of GvH. Non responder (NR) if the patient does not improve after treatment. | 28 days after inclusion | 
| Response at 84 days after onset of graft versus host disease | Response will be measured as: Partial response (PR) if the patient has improved one grade in the overall GvH. Complete response (CR) if the patient is free of GvH. Non responder (NR) if the patient does not improve after treatment. | Up to 84 days after inclusion | 
| Response at 168 days after onset of graft versus host disease | Response will be measured as: Partial response (PR) if the patient has improved one grade in the overall GvH. Complete response (CR) if the patient is free of GvH. Non responder (NR) if the patient does not improve after treatment. | Up to 168 days after inclusion | 
| Side effects | Adverse effects related to the treatment. | Up to 6 months after inclusion | 
| Incidence of severe infections | Severe bacterial, viral and fungal infections. | Up to one year after inclusion | 
| Disease free survival | Survival free from relapse. | Up to one year after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem Cell Transplantation, Decidual Stromal Cells