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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
The purpose of this study is to evaluate the 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.
Patients with GVHD grade 2-4, will receive decidual stromal cells at approximately 1x10^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Decidual Stromal Cells | Active Comparator | Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids since no more than 7 days will be given Decidual Stromal Cell therapy. |
|
| Late Decidual Stromal Cells | Active Comparator | Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids for longer than 7 days will be given Decidual Stromal Cell therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Decidual stromal cell therapy | Biological | Intervention given within 7 days after corticosteroids. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Actuarial survival at one year after onset of graft versus host disease | 12 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Response at 28 days after onset of graft versus host disease | 28 days after inclusion | |
| Side effects | Up to 6 months after inclusion | |
| Incidence of severe infections |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olle Ringdén, MD, PhD | Contact | +46858582672 | olle.ringden@ki.se | |
| Helen Kaipe, PhD | Contact | +46700901052 | helen.kaipe@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Olle Ringdén, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | 14186 | Sweden |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| Late Decidual stromal cell therapy | Biological | Intervention given after 7 days after corticosteroids. |
|
| Up to 12 months after inclusion |
| Disease free survival | 12 months after inclusion |