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Recruiting Phase 1 NCT06245746

UCMSC-Exo for Chemotherapy-induced Myelosuppression in Acute Myeloid Leukemia

Trial Parameters

Condition Acute Myeloid Leukemia
Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 9
Sex ALL
Min Age 18 Years
Max Age 60 Years
Start Date 2025-02-26
Completion 2026-02
Interventions
umbilical cord derived mesenchymal stem cells exosomes (UCMSC-Exo)

Brief Summary

The purpose of the study is to explore the safety and efficacy of UCMSC-Exo in consolidation chemotherapy-induced myelosuppression in patients with acute myeloid leukemia after achieving complete remission.

Eligibility Criteria

Inclusion Criteria: 1. Aged between 18 and 60 years old; 2. Acute myeloid leukemia (AML, AML subtype M3 excluded) diagnosed according to the 2022 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia, who have achieved complete remission (CR1) and are going to receive consolidation therapy (cytarabine or cytarabine-based combined regimen, the cycle of consolidation therapy is not limited); 3. The participant or his/her legal guardian is adequately informed of the nature and risks of the study, voluntarily participates in the study with signed informed consent; 4. Male or female; 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 (by the day chemotherapy is initiated) 6. Estimated survival of at least 3 months; 7. Adequate major organ function: 1. Respiratory function: indoor oxygen saturation of at least 95%; 2. Cardiac function: ejection fraction of left ventricular of at least 45%; 3. Hepatic function: alanine ami

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