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

Last updated: March 11, 2025
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasm Metastasis

Treatment

Dose extension

Dose escalation

Clinical Study ID

NCT06792682
IIT2024098
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age≥18 years old; gender is not limited.

  2. Meet the diagnostic criteria for secondary poor graft function: After 28 days oftransplantation, 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 7consecutive days without platelet infusion, Hb ≥ 80g/L for 2 consecutive weekswithout red blood cell infusion) again developed two or three line cytopenia lastingmore than 2 weeks. Bone marrow examination revealed low myelodysplasia, remission ofprimary disease, complete donor chimeric cells, and no severe graft-versus-hostdisease (GVHD) or disease recurrence.

  3. Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2 points.

  4. Subjects sign informed consent.

Exclusion

Exclusion Criteria:

  1. Serious infection not controlled.

  2. Active bleeding.

  3. Patients with cardiac insufficiency (ejection fraction<50%), or suffering fromserious heart disease, including myocardial infarction, cardiac insufficiency, etc.

  4. Patients with hepatic and renal insufficiency (total bilirubin>35µmol/L, ALT andAST>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 thestudy.

Study Design

Total Participants: 15
Treatment Group(s): 2
Primary Treatment: Dose extension
Phase: 1
Study Start date:
February 14, 2025
Estimated Completion Date:
February 29, 2028

Connect with a study center

  • Institute of Hematology & Blood Diseases Hospital, China

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

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