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The purpose of this study was to evaluate the safety and efficacy of umbilical cord blood mononuclear cell in the treatment of refractory immune effector cell-related hemocytopenia by observing the efficacy related factors and adverse reactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional hematopoietic recovery therapy | Active Comparator | Conventional hematopoietic recovery therapy including but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc. |
|
| Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells | Experimental | Umbilical cord blood mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical cord blood mononuclear cells | Biological | Intravenous infusion of UCB-MNCs (3×10^8/ time, once a week, four times in total) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The recovery time of neutrophils | On the first day after discontinuing G-CSF, the neutrophil count remained above 1.0 × 10^9/L for 7 consecutive days | 1 year |
| The recovery time of platelet | Starting from the second day of the most recent platelet transfusion, the first day of platelet count>50 × 10^9/L lasting for 7 days | 1 year |
| Safety of infusion | Acute allergies or infections related to umbilical cord blood mononuclear cell infusion, as well as shock and other infusion related reactions symptoms including but not limited to chills, fever, CRP, PCT, etc | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of hemoglobin levels after infusion | Hemoglobin content in blood routine examination | 1 year |
| Immune function reconstruction indicators at 1, 3, 6, and 12 months after transfusion | Including but not limited to CD3, CD4, CD8, CD19, etc. in lymphoid subgroups |
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Inclusion Criteria:
1) The neutrophils again decreased to grade ≥3 within 1 week after G-CSF discontinuation, or 2) Unable to detach from red blood cell or platelet transfusion (infusion time less than one week requires re-infusion) (5) Understand the research protocol and sign the informed consent voluntarily
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kai Hu | Contact | +86 150 1039 0336 | huk@gobroadhealthcare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing GoBroad Hospital | Beijing | Beijing Municipality | 102200 | China |
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| Conventional hematopoietic recovery therapy | Combination Product | Including but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc. |
|
| 1, 3, 6, and 12 months |
| Overall survival rate | The proportion of participants who survived during the study period | 2 and 5 year |