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The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Patients With Secondary Poor Graft Function After Hematopoietic Stem Cell Transplantation
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2025-02-14
Completion Date
2028-02
Last Updated
2025-03-13
Healthy Volunteers
No
Conditions
Interventions
Dose escalation
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.
Dose extension
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.
Locations (1)
Institute of Hematology & Blood Diseases Hospital, China
Tianjin, Tianjin Municipality, China