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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

NCT06792682 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-03-13

No results posted yet for this study

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.

Conditions

  • Poor Graft Function

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.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-14
Primary Completion
2027-12-31
Completion
2028-02-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06792682 on ClinicalTrials.gov