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This is a prospective, single-arm, single-center clinical study designed to evaluate the safety of autologous hematopoietic stem cell infusion for the treatment of prolonged cytopenia following CAR-T cell therapy. Approximately 20 patients will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous hematopoietic stem cell infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous hematopoietic stem cell infusion | Biological | Autologous hematopoietic stem cell infusion (0.5-3.0×10^6/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Neutrophil Counts After Autologous Stem Cell Infusion | Evaluate changes in neutrophil counts following autologous hematopoietic stem cell infusion. | up to 6 months after infusion |
| Changes in Platelet Counts After Autologous Stem Cell Infusion | Evaluate changes in platelet counts following autologous hematopoietic stem cell infusion. | up to 6 months after infusion |
| Changes in Hemoglobin Levels After Autologous Stem Cell Infusion | Evaluate changes in hemoglobin levels following autologous hematopoietic stem cell infusion. | up to 6 months after infusion |
| Incidence and Severity of Adverse Events Following Autologous Stem Cell Infusion | Assess safety by monitoring infusion-related adverse events, graded according to CTCAE v5.0. | up to 6 months after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Infections After Autologous Stem Cell Infusion | Evaluate the frequency and types of infections following stem cell infusion, including bacterial, viral, and fungal infections. | up to 6 months after infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang An, PhD&MD | Contact | 86-022-23909171 | angang@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | China |
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