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RECRUITING
NCT06792682
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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