A Single-center, Prospective Trial of the Safety and Efficacy of UCMSC-Exo in Consolidation Chemotherapy-induced Myelosuppression in Patients With Acute Myeloid Leukemia After Achieving Complete Remission
Sponsor study identifier
interventional
9
1 country
1
Study Start
February 26, 2025
Actual (reported)Primary Completion
February 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 30, 2024
Actual (reported)February 7, 2024
Actual (reported)February 26, 2025
Actual (reported)February 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To investigate the safety characteristics, percentages will be calculated and grade will be evaluated.
From the day that UCMSC-Exo is infused to up to 28 days (short-term safety follow-up) and 1 year (long-term safety follow-up)
Dose-limiting toxicities（DLT)
During the DLT observation period, the subject has an adverse event that is reasonably related to UCMSC-Exo infusion (possibly, likely or definitely related).
From the day that UCMSC-Exo is infused to up to 14 days
Maximum tolerated dose (MTD)
During the dose-escalation, the highest dose of dose-limiting toxicity for subjects no more than 1/6 in the dose group of at least 6 evaluable subjects of the study drug.
UCMSC-Exo will be preset with 3 escalation dose levels in single time infusion.
UCMSC-Exo will be infused intravenously.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Wuhan Union Hospital
Wuhan, Hubei, 430000, China
Wu D, He W, He J, Wu Y, Chen W, Zhang J, Yang S, Tan Y, Chen Z, Li Q. UCMSC-Exo for chemotherapy-induced myelosuppression in acute myeloid leukemia: a phase I clinical trial protocol. Nanomedicine (Lond). 2026 Jul;21(13):1873-1883. doi: 10.1080/17435889.2026.2692455. Epub 2026 Jun 25.
Qiubai Li, Professor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
First Submitted
January 30, 2024
First Posted
February 7, 2024
Study Start
February 26, 2025
Actual (reported)Primary Completion
February 2026
Estimated (date passed)From the day that UCMSC-Exo is infused to up to 14 days
Time to absolute neutrophil count recovery
From the start of chemotherapy to up to 42 days
Incidence of febrile neutropenia
From the start of chemotherapy to up to 42 days
Duration of febrile neutropenia
From the start of chemotherapy to up to 42 days
Incidence of severe thrombocytopenia
From the start of chemotherapy to up to 42 days
Time to severe thrombocytopenia recovery
From the start of chemotherapy to up to 42 days
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 21, 2025
Record last verified: 2025-03
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Source: ClinicalTrials.gov.
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