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This study is conducted in a prospective, single-center clinical design and is divided into two stages: dose escalation and dose extension. Patients meeting the diagnostic criteria of secondary poor graft function are selected as the study objects. The safety data of umbilical cord blood mononuclear cells in the treatment of secondary poor graft function are obtained through dose escalation stage, and then one dose is selected for dose extension stage to explore the efficacy of umbilical cord blood mononuclear cells in treating secondary poor graft function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical Cord Blood Mononuclear Cells | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose escalation | Biological | Three dose groups are preset. The doses are 2.0×10^6/kg/time, 3.5×10^6/kg/time and 5.0×10^6/kg/ time respectively, in accordance with the "3+3" dose escalation principle, and proceed in turn. Each subject receives conventional treatment plus umbilical cord blood mononuclear cells therapy, with 4 consecutive intravenous infusions of umbilical cord blood mononuclear cells at 1 week intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment | Incidence of adverse events | From date of the last infusion of umbilical cord blood mononuclear cells until the date of end of follow-up, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| The recovery time of platelet | The first day of 3 consecutive days with PLT ≥ 20×10^9/L without platelet transfusion | Two months after the last infusion of umbilical cord blood mononuclear cells |
| The recovery time of neutrophil |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| erlie EL Jiang | Contact | +86-15122538106 | jiangerlie@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital, China | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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| Dose extension | Biological | According to the safety data of dose escalation stage, one dose group is selected for extension. Each subject receives conventional treatment plus umbilical cord blood mononuclear cells therapy, with 4 consecutive intravenous infusions of umbilical cord blood mononuclear cells at 1 week intervals. |
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The first day of 3 consecutive days with ANC ≥ 0.5×10^9/L without G-CSF application
| Two months after the last infusion of umbilical cord blood mononuclear cells |