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The purpose of this study is to evaluate the safety and efficacy of PROMOSTEM (human umbilical cord blood-derived mesenchymal stem cells) at a dose of 1 and 5x1,000,000 hMSC/kg in subject for the promotion of an engraftment and prevention of graft rejection and Graft-Versus-Host Disease after unrelated hematopoietic stem cell transplantation for children with acute leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | at a dose of 1x1,000,000 hMSC/kg |
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| 2 | Experimental | at a dose of 5x1,000,000 hMSC/kg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human umbilical cord blood-derived mesenchymal stem cells | Biological | 1x1,000,000 hMSC/kg, IV after unrelated HSCT |
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| Measure | Description | Time Frame |
|---|---|---|
| - Day of neutrophil engraftment - Day of platelet engraftment - Evaluation of chimerism - Evaluation of engraftment rate | 28 and 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| - AGVHD grade | 100 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Hoe Koo, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
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| Human umbilical cord blood-derived mesenchymal stem cells | Biological | 5x1,000,000 hMSC/kg, IV after unrelated HSCT |
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