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Allo-hematopoietic stem cell transplantation(HSCT) is the only way to cure β-thalassemia major at present. To expand donor pool,we developed a haplo-identical HSCT (Hi-HSCT) platform. But in prior Hi-HSCT using high dose post-transplant Cyclophosphamide in patients with leukemia, cytopenia post-transplant often developed, which was considered as a symptom of GVHD. Therefore, the investigators add unrelated umbilical cord blood (UCB) to the Hi-HSCT. It has reported that, as third-party cells, UCB will reduce GVHD.The purpose of this study is to determine whether unrelated UCB following Hi-HSCT can improve outcomes of Hi-HSCT in patients with β-thalassemia major.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hi-HSC-CBT | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| unrelated CB following haplo-identical hematopoietic stem cells transplantation | Genetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival(OS) | the measure is a composite | 12 months |
| TM-free survival(TFS) | the measure is a composite | 12 months |
| Transplant Related Martality (TRM) | the measure is a composite | 12 months |
| Primary or Secondary Graft Rejection (GR) | the measure is a composite | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The cumulative incidences of acute graft-versus-host disease(GVHD) | the measure is a composite | 12 months |
| The cumulative incidences of chronic graft vesus host disease (cGVHD) | the measure is a composite |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunfu Li, professor | Contact | +86 20 61641921 | chunfugzcn@126.com | |
| Zhiyong Peng, Doctor | Contact | +86 20 61641925 | pengzhiyong8@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of paediatrics,Nangfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| 12 months |
| ID | Term |
|---|---|
| D017086 | beta-Thalassemia |
| ID | Term |
|---|---|
| D013789 | Thalassemia |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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