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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
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.
Institute of Hematology & Blood Diseases Hospital, China
Tianjin, Tianjin Municipality, China
RECRUITINGSafety assessment
Incidence of adverse events
Time frame: 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
The recovery time of platelet
The first day of 3 consecutive days with PLT ≥ 20×10\^9/L without platelet transfusion
Time frame: Two months after the last infusion of umbilical cord blood mononuclear cells
The recovery time of neutrophil
The first day of 3 consecutive days with ANC ≥ 0.5×10\^9/L without G-CSF application
Time frame: Two months after the last infusion of umbilical cord blood mononuclear cells
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