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

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

This study is testing if umbilical cord blood cells can help people with poor graft function after a stem cell transplant feel better and improve their health.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06792682 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with secondary poor graft function after hematopoietic stem cell transplantation.

Not a fit: Patients with uncontrolled serious infections, active bleeding, or significant heart disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery and overall outcomes for patients with secondary poor graft function.

How similar studies have performed: While the use of umbilical cord blood cells in other contexts has shown promise, this specific application for secondary poor graft function is novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Tianjin, Tianjin Municipality

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

Study contacts

• Study coordinator: erlie EL Jiang

Conditions Poor Graft Function; Secondary poor graft function; Umbilical cord blood mononuclear cells