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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decidual Stromal Cells as last line treatment | Experimental | 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. |
|
| Decidual Stromal Cells | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decidual Stromal Cells thawed in plasma | Biological |
| ||
| Decidual Stromal Cells thawed in human albumin |
| Measure | Description | Time Frame |
|---|---|---|
| Actuarial survival at six months after first DSC infusion | 6 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Response at 28 days after onset of graft versus host disease | Response will be measured as:
| 28 days after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
None.
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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 | Recruiting | Stockholm | 14186 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23701127 | Background | Erkers T, Nava S, Yosef J, Ringden O, Kaipe H. Decidual stromal cells promote regulatory T cells and suppress alloreactivity in a cell contact-dependent manner. Stem Cells Dev. 2013 Oct 1;22(19):2596-605. doi: 10.1089/scd.2013.0079. Epub 2013 Jul 2. | |
| 23307526 | Result | Ringden O, Erkers T, Nava S, Uzunel M, Iwarsson E, Conrad R, Westgren M, Mattsson J, Kaipe H. Fetal membrane cells for treatment of steroid-refractory acute graft-versus-host disease. Stem Cells. 2013 Mar;31(3):592-601. doi: 10.1002/stem.1314. |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000075462 | Serum Albumin, Human |
| ID | Term |
|---|---|
| D012709 | Serum Albumin |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Biological |
|
| Response at 84 days after onset of graft versus host disease |
Response will be measured as:
|
| Up to 84 days after inclusion |
| Response at 168 days after onset of graft versus host disease | Response will be measured as:
| 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 |
| 31173898 | Derived | Sadeghi B, Remberger M, Gustafsson B, Winiarski J, Moretti G, Khoein B, Klingspor L, Westgren M, Mattsson J, Ringden O. Long-Term Follow-Up of a Pilot Study Using Placenta-Derived Decidua Stromal Cells for Severe Acute Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2019 Oct;25(10):1965-1969. doi: 10.1016/j.bbmt.2019.05.034. Epub 2019 Jun 4. |
| D001798 |
| Blood Proteins |