Using umbilical cord blood cells to treat poor graft function after stem cell transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of umbilical cord blood mononuclear cells in patients experiencing secondary poor graft function following hematopoietic stem cell transplantation. The study is structured in two stages: an initial dose escalation phase to assess safety, followed by a dose extension phase to evaluate efficacy. Patients who meet specific diagnostic criteria for secondary poor graft function will be enrolled and monitored throughout the trial. The goal is to determine the optimal dose of umbilical cord blood cells that can improve patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Hematology & Blood Diseases Hospital, China
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: erlie EL Jiang
• Email: jiangerlie@ihcams.ac.cn
• Phone: +86-15122538106

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.