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NCT Number: NCT06792682

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institute of Hematology & Blood Diseases Hospital, China

Tianjin, Tianjin Municipality, 300020, China

Location status: Recruiting

Location contact

jiang erlie

CONTACT

[email protected]

+86-15122538106

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age≥18 years old; gender is not limited.
  • 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.
  • Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2 points.
  • Subjects sign informed consent.

Exclusion criteria

  • Serious infection not controlled.
  • Active bleeding.
  • Patients with cardiac insufficiency (ejection fraction<50%), or suffering from serious heart disease, including myocardial infarction, cardiac insufficiency, etc.
  • 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).
  • Pregnant or lactating women.
  • Concurrent malignant tumors of other organs.
  • Failure to understand or follow the research protocol.
  • Patients participating in other clinical investigations.
  • Other conditions that the investigators consider inappropriate to participate in the study.

Treatment and study plan

Dose escalation

Biological

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

Biological

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.

Primary outcomes

  1. Safety assessment

    Time frame: 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 outcomes

  1. The recovery time of platelet

    Time frame: 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

  2. The recovery time of neutrophil

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

erlie EL Jiang

CONTACT

[email protected]

+86-15122538106

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 27, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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