The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Patients With Secondary Poor Graft Function After Hematopoietic Stem Cell Transplantation

Phase 1

Recruiting

• Conditions: Poor Graft Function
• Interventions: Biological: Dose escalation; Biological: Dose extension

• Registration Number: NCT06792682
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-27
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-21
• Study First Posted: 2025-01-27
• Study Start: 2025-02-14
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2027-12
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Age≥18 years old; gender is not limited.
2. Meet the diagnostic criteria for secondary poor graft function: After 28 days of transplantation, patients who had achieved hematopoietic reestablishment (ANC ≥ 0.5×10^9/L for 3 consecutive days without G-CSF application, PLT ≥ 20×10^9/L for 7 consecutive days without platelet infusion, Hb ≥ 80g/L for 2 consecutive weeks without red blood cell infusion) again developed two or three line cytopenia lasting more than 2 weeks. Bone marrow examination revealed low myelodysplasia, remission of primary disease, complete donor chimeric cells, and no severe graft-versus-host disease (GVHD) or disease recurrence.
3. Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2 points.
4. Subjects sign informed consent.

Exclusion Criteria

1. Serious infection not controlled.
2. Active bleeding.
3. Patients with cardiac insufficiency (ejection fraction<50%), or suffering from serious heart disease, including myocardial infarction, cardiac insufficiency, etc.
4. Patients with hepatic and renal insufficiency (total bilirubin>35µmol/L, ALT and AST>2 times of the upper limit of normal; serum creatinine>130µmol/L).
5. Pregnant or lactating women.
6. Concurrent malignant tumors of other organs.
7. Failure to understand or follow the research protocol.
8. Patients participating in other clinical investigations.
9. Other conditions that the investigators consider inappropriate to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Umbilical Cord Blood Mononuclear Cells	Dose escalation	-
Umbilical Cord Blood Mononuclear Cells	Dose extension	-

Primary Outcome Measures

Name	Time	Method
Safety assessment	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

Secondary Outcome Measures

Name	Time	Method
The recovery time of platelet	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
The recovery time of neutrophil	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

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital, China; 🇨🇳 Tianjin, Tianjin, China