Institute of Hematology & Blood Diseases Hospital, China
Tianjin, Tianjin Municipality, 300020, China
Location status: Recruiting
NCT Number: NCT06792682
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Tianjin, Tianjin Municipality, 300020, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Incidence of adverse events
Time frame: Two months after the last infusion of umbilical cord blood mononuclear cells
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 first day of 3 consecutive days with ANC ≥ 0.5×10^9/L without G-CSF application
Contact information is provided by the study sponsor or research team.
Institute of Hematology & Blood Diseases Hospital, China
Other
Clinical Study to Explore the Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Patients With Secondary Poor Graft Function After Hematopoietic Stem Cell Transplantation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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