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This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in aplastic anemia.
Aplastic anemia (AA) is a disorder thought to be caused by an immune-mediated bone marrow failure. Not all people with AA are eligible for today's standard treatments. One new treatment approach uses umbilical cord derived mesenchymal stem cells-specialized cells capable of developing into other types of cells-to provide the basis for clinical application. The aim of the present study is to investigate the safety and efficacy of vein infusion of allogeneic mesenchymal stem cells in patients with AA .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mesenchymal stem cells | Experimental | According to the inclusion and exclusion criteria, selected patients were divided into a cell therapy group and a control group. Umbilical cord derived mesenchymal stem cells at a dose of 100-300 million by intravenous infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal stem cells | Biological | Patients in the cell treated group were given umbilical cord derived mesenchymal stem cells by intravenous infusion besides conventional therapy. There was only conventional treatment in the control group. All patients after treatment for 1months, 3months, 6months and 9months were evaluated respectively the therapeutic effect. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin levels in peripheral blood | The recovery of bone marrow erythrocyte is evaluated by hemoglobin levels (g/L) in peripheral blood. | Post cell transplantation: 9months |
| Measure | Description | Time Frame |
|---|---|---|
| The number of red blood cell in peripheral blood | The improvement of bone marrow erythrocyte is evaluated by red blood cell count (×10^12/L) in peripheral blood. | Post cell transplantation: 1, 3, 6, 9months |
| The number of granulocyte in peripheral blood |
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Inclusion Criteria:
Exclusion Criteria:
- Patients with AA have to be disqualified from this study if any of the following is applicable.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Zhang, Master | Contact | 86-311-85917384 | june_luck@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Baoyong Yan, Doctor | The First Hospital of Hebei Medical University | Study Chair |
| Qingchi Liu, Doctor | The First Hospital of Hebei Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050031 | China |
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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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|
The recovery of bone marrow granulocyte is evaluated by granulocyte count (×10^9/L) in peripheral blood. |
| Post cell transplantation: 1, 3, 6, 9months |
| The number of white blood cell in peripheral blood | The improvement of bone marrow granulocyte is evaluated by white blood cell count (×10^9/L) in peripheral blood. | Post cell transplantation: 1, 3, 6, 9months |
| The evaluation of bone marrow megakaryocytic series | The status of megakaryocytic series is evaluated by platelet count (×10^9/L) in peripheral blood. | Post cell transplantation: 1, 3, 6, 9months |
| adverse reaction | Adverse reaction includes temperature changes(℃), the change of blood pressure(mmHg) and allergic reaction. | Post cell transplantation: 1, 3, 6, 9months |
| Quanhai Li, Doctor |
| The First Hospital of Hebei Medical University |
| Study Director |
| Xiaohui Jia, Doctor | The First Hospital of Hebei Medical University | Principal Investigator |
| Xianyun Wang, Doctor | The First Hospital of Hebei Medical University | Principal Investigator |
| Fan Zhang, Bachelor | The First Hospital of Hebei Medical University | Principal Investigator |
| Yang Shen, Master | The First Hospital of Hebei Medical University | Principal Investigator |
| Bing Ma, Master | The First Hospital of Hebei Medical University | Principal Investigator |
| Wanyi Yin, Master | The First Hospital of Hebei Medical University | Principal Investigator |
| Dan Zhao, Master | The First Hospital of Hebei Medical University | Principal Investigator |
| Bojian Sun, Master | The First Hospital of Hebei Medical University | Principal Investigator |
| D001855 | Bone Marrow Diseases |