NCT06792682 The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Patients With Secondary Poor Graft Function After Hematopoietic Stem Cell Transplantation
| NCT ID | NCT06792682 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Poor Graft Function |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-02-14 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2025-02-14 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06792682 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Poor Graft Function. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06792682 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06792682 currently recruiting?
Yes, NCT06792682 is actively recruiting participants. Contact the research team at jiangerlie@ihcams.ac.cn for enrollment information.
Where is the NCT06792682 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06792682 clinical trial?
NCT06792682 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 15 participants.