A Phase 1/2 interventional study of umbilical cord derived mesenchymal stem cells in Hematologic Neoplasms, Neutropenia and Anemia, sponsored by Wuhan Union Hospital, China. Status unknown at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-05.
Sponsored by Wuhan Union Hospital, China · Phase 1/2, Interventional, and Treatment
The purpose of the study is to explore the safety and efficacy of umbilical cord derived mesenchymal stem cells in treatment-induced myelosuppression in patients with hematologic malignancies.
Despite the improved prognosis of patients with hematologic malignancies, almost all patients will experience severe myelosuppression induced by anti-cancer treatment, 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 interrruptions of anti-cancer treatment, failure of hematopoietic stem cell transplantation, and also patients' 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 (UC-MSCs), as a kind of 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 hematologic malignancies and treatment-induced myelosuppression will be invited to participate in the Phase Ib/II study, to receive UC-MSCs intravenous infusion and follow-up visits of up to 2 years after enrollment.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 181 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Wuhan Union Hospital, China is the lead sponsor of 230 studies on the registry; 104 are open to participants now.
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Either type of primary hematologic malignancies listed below:
Adequate major organ function:
Exclusion Criteria:
Participants with fertility plan;
Note: For female participants, they should be surgical sterilized or post-menopausal, or agree to utilize a medically recognised method of contraception (such as intrauterine device, condom) during treatment period of the study and within 6 months after the end of treatment period of the study; For male participants, they should be surgical sterilized or agree to utilize a medically recognised method of contraception (such as intrauterine device, condom) during treatment period of the study and within 6 months after the end of treatment period of the study;
In the Phase Ib study, participants will be those with treatment-induced myelosuppression and acute myeloid leukemia/acute lymphoblastic leukemia, UC-MSCs will be preset with 5 escalation dose levels: dose A , dose B, dose C ,dose D and dose E, frequency of infusion will be preset with 3 escalation levels: frequency 1, frequency 2, frequency 3, total course of treatment: 2 weeks; In the Phase II study, participants will be those with treatment-induced myelosuppression and acute myeloid leukemia/acute lymphoblastic leukemia/primary hematological maligancies who are going to receive hematopoietic stem cell transplantation, UC-MSCs will be preset according to the recommended phase II dose (RP2D) from the Phase Ib study, total course of treatment: 2 weeks.
Biological: umbilical cord derived mesenchymal stem cells
umbilical cord derived mesenchymal stem cells, intravenous infusion
Dose-limiting toxicities（DLT)
During the DLT observation period, the subject has an adverse event that is reasonably related to UC-MSCs infusion (possibly, likely or definitely related).
Time frame: 4 days after the last UC-MSCs dose, up to 12 days
Incidence 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 the last UC-MSCs dose is used to up to 21 days
Maximum tolerated dose (MTD)
During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/3 in the dose group of at least 6 evaluble subjects of the study drug after the last UC-MSCs dose.
Time frame: From the day that the last UC-MSCs dose is used to up to 4 days
Time to absolute neutrophil count recovery
To investigate the efficacy characteristics, time will be measured in days.
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Incidence of febrile neutropenia
To investigate the efficacy characteristics, percentages will be calculated.
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation 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 anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Incidence of severe thrombocytopenia
To investigate the efficacy characteristics, percentages will be calculated.
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation 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 anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Incidence of severe anemia
To investigate the efficacy characteristics, percentages will be calculated.
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation 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 anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Incidence of infetion
To investigate the efficacy characteristics, percentages will be calculated.
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Duration of infetion
To investigate the efficacy characteristics, the duration will be measured in days.
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Incidence of bleeding
To investigate the efficacy characteristics, percentages will be calculated.
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation 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 anti-cancer therapy or completion of hematopoietic stem cell transplantation 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 anti-cancer therapy or completion of hematopoietic stem cell transplantation 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 anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Time to achievement of complete remission
To investigate the efficacy characteristics, time will be measured in days.
Time frame: From enrollment to up to 28 days
Duration of complete remission
To investigate the safety characteristics, the duration will be measured in days or months.
Time frame: From enrollment to maximun up to 2 years
Event free survival
From enrollment to the day of any event.
Time frame: From enrollment to maximun up to 2 years
Overall survival
From enrollment to the day of death caused by any reason.
Time frame: From enrollment to maximun up to 2 years
Incidence of infusion reactions in 2 years
To investigate the safety characteristics, percentages will be calculated.
Time frame: 2 years since the last UC-MSCs infusion
Incidence of secondary tumor in 2 years
To investigate the safety characteristics, percentages will be calculated.
Time frame: 2 years since the last UC-MSCs infusion
Cumulative incidence of relapse of primary disease in 2 years
To investigate the safety characteristics, percentages will be calculated.
Time frame: 2 years since the last UC-MSCs infusion
Plan to share: No
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This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Wuhan Union Hospital, China