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| ID | Type | Description | Link |
|---|---|---|---|
| H0806-MSC-2014 | Other Grant/Funding Number | NSFC |
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Mesenchymal Stem Cells (MSC) is a non Hematopoietic Stem Cells (HSC) in adult bone marrow and takes part in the bone marrow microenvironment. The response rate of early treatment on Children's SAA application combined with anti-thymocyte globulin (ATG) (40-50 days after ATG treatment) is associated with long-term effect. The injection of Umbilical Cord Derived Mesenchymal Stem Cells combined with ATG improves the efficacy of children with SAA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSC+ATG | Experimental | The first agent MSC injection, began two weeks after ATG application; Each patient was injected three times, one time per week; Study on single dose tolerance and efficacy index; Each subjects received three dose groups of treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSC+ATG | Drug | MSC+ATG:Starting dose was 0.5-1.0 × 106 cells /kg; And the maximum tolerated dose was 1 ×107 cells /kg after ATG application. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The response and complete remission rate with different doses of Umbilical Cord Derived MSC to treat child with SAA | Complete response (CR) was defined as achieving normal levels of hemoglobin adjusted for age, platelet count >100*109/L, and absolute neutrophil count (ANC) >1.5*1.0 9/L. Partial response (PR) was defined as injection independence, reticulocyte count>30*109/L, platelet count >20*109/L, and ANC>0.5*1.0 9/L above the baseline. Persistence of injection requirement or death was evidence of no response (NR). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The relapse rate with different doses of MSC to treat child with SAA | The relapse was defined as injection dependence again; or progressed or paroxysmal nocturnal hemoglobinuria (PNH)/acute myeloid leukemia/myelodysplasia syndrome(MDS); or cyclosporin A (CsA) dependence. | 3-10 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaofan Zhu, MD | Contact | +86-22-23909001 | zhuxf6465@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaofan Zhu, MD | Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Tianjin | 300020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33639900 | Derived | Lan Y, Liu F, Chang L, Liu L, Zhang Y, Yi M, Cai Y, Feng J, Han Z, Han Z, Zhu X. Combination of umbilical cord mesenchymal stem cells and standard immunosuppressive regimen for pediatric patients with severe aplastic anemia. BMC Pediatr. 2021 Feb 27;21(1):102. doi: 10.1186/s12887-021-02562-x. |
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| ID | Term |
|---|---|
| D000741 | Anemia, Aplastic |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000080983 | Bone Marrow Failure Disorders |
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| D001855 | Bone Marrow Diseases |