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This is a single participant study of decidual stromal cells (DSC) for the treatment of steroid refractory graft-versus-host disease (GVHD) in a patient with myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with MDS/MPN | Experimental | DSCs will be given 1 × 10^6 cells per kilogram of participant's body weight intravenously, administered once per week up to a maximum of six weeks depending on the clinical response. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decidual stromal cells (DSC) | Biological | DSCs are isolated from donated human placenta and have been shown to have anti-inflammatory effects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eastern Cooperative Oncology Group Performance Status Score | 6 weeks | |
| Karnofsky Performance Score | 6 weeks | |
| Graft-Versus-Host Disease Severity | By grade | 6 weeks |
| Aspartate Transaminase levels | 6 weeks | |
| Alanine aminotransferase levels | 6 weeks | |
| Alkaline phosphatase levels | 6 weeks | |
| Bilirubin levels | 6 weeks | |
| C-reactive protein levels | 6 weeks |
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A single participant with myelodysplastic syndrome/myeloproliferative neoplasm located at Princess Margaret Cancer Centre who experienced steroid-refractory graft-vs-host disease after receiving an allogeneic hematopoietic cell transplant and have no standard treatment options available.
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| Name | Affiliation | Role |
|---|---|---|
| Ivan Pasic, MD | Princess Margaret Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
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| ID | Term |
|---|---|
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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