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.
Despite the improved prognosis of patients with acute myeloid leukemia, almost all patients will experience severe myelosuppression induced by chemotherapy, leading to a series of complications such as infection due to neutropenia, bleeding due to thrombocytopenia and/or impaired major organ function such as cardiac function due to anemia, which are the main reasons for dose reduction, dose interruptions of chemotherapy and also treatment-related death. It is of significant clinical importance and an urgent need to promote early recovery of myelosuppression and reduce risks of related complications as well as medical burdens. Umbilical cord derived mesenchymal stem cells exosomes (UCMSC-Exo), as the key effector of the stem cells with multipotential, can widely act on the functional cell units of bone marrow microenvironment and promote the repairment and regeneration of key cells such as hematopoietic stem cells, mesenchymal stem cells and endothelial cells, thus making it an ideal means for effectively promoting recovery of myelosuppression. Patients with acute myeloid leukemia who have achieved complete remission (CR) and are going to receive consolidation chemotherapy will be invited to participate in the study, to receive UCMSC-Exo intravenous infusion and follow-up visits of up to 1 years after enrollment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
UCMSC-Exo will be infused intravenously.
Wuhan Union Hospital
Wuhan, Hubei, China
RECRUITINGIncidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To investigate the safety characteristics, percentages will be calculated and grade will be evaluated.
Time frame: 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).
Time frame: 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.
Time frame: From the day that UCMSC-Exo is infused to up to 14 days
Time to absolute neutrophil count recovery
To investigate the efficacy characteristics, time will be measured in days.
Time frame: From the start of chemotherapy to up to 42 days
Incidence of febrile neutropenia
To investigate the efficacy characteristics, percentages will be calculated.
Time frame: From the start of chemotherapy to up to 42 days
Duration of febrile neutropenia
To investigate the efficacy characteristics, the duration will be measured in days.
Time frame: From the start of chemotherapy to up to 42 days
Incidence of severe thrombocytopenia
To investigate the efficacy characteristics, percentages will be calculated.
Time frame: From the start of chemotherapy to up to 42 days
Time to severe thrombocytopenia recovery
To investigate the efficacy characteristics, time will be measured in days.
Time frame: From the start of chemotherapy to up to 42 days
Incidence of severe anemia
To investigate the efficacy characteristics, percentages will be calculated.
Time frame: From the start of chemotherapy to up to 42 days
Time to severe anemia recovery
To investigate the efficacy characteristics, time will be measured in days.
Time frame: From the start of chemotherapy to up to 42 days
Incidence of infection
To investigate the efficacy characteristics, percentages will be calculated.
Time frame: From the start of chemotherapy to up to 42 days
Duration of infection
To investigate the efficacy characteristics, the duration will be measured in days.
Time frame: From the start of chemotherapy to up to 42 days
Incidence of bleeding
To investigate the efficacy characteristics, percentages will be calculated.
Time frame: From the start of chemotherapy to up to 42 days
Duration of bleeding
To investigate the efficacy characteristics, the duration will be measured in days.
Time frame: From the start of chemotherapy to up to 42 days
Application rate of blood transfusion
To investigate the efficacy characteristics, percentages will be calculated.
Time frame: From the start of chemotherapy to up to 42 days
Application rate of anti-infective agents
To investigate the efficacy characteristics, percentages will be calculated.
Time frame: From the start of chemotherapy to up to 42 days
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