Umbilical cord blood (UCB) is rich in haematopoietic stem progenitor cells and immune cells, and is used for transplantation for a variety of haematological disorders with the advantages of low mating requirements and fewer transplant complications. By March 2025 China's seven (eight) public cord blood stem cell banks had frozen more than 280,000 public umbilical cord blood, while the percentage of those frozen for ≥10 years was 26%, making clinical application a concern. The previous study showed that long-term freezing impairs cellular mitochondrial function leading to decreased reconstruction of cord blood haematopoietic stem progenitor cells and impaired differentiation into the megakaryotic lineage, and that intervention with the antioxidant radicicol thiols (SFN) can partially rescue the cellular functional damage caused by freezing. The findings were based on immunodeficient animals, and clinical studies are urgently needed to determine whether SFN intervention can promote post-transplant haematopoietic reconstitution in patients with long term cryopreserved (≥10 years) UCB. In this project, the investigators propose to conduct a single-arm, open, single-centre phase I-II clinical study on the safety and feasibility of dietary supplement SFN to promote early haematopoietic restoration after cord blood transplantation to evaluate the safety and feasibility of the use of long-frozen UCB for peri-infusion SFN use in adult transplant recipients, and to reveal the effect of peri-infusion SFN use on neutrophil implantation. This project will provide scientific guidance to promote the clinical application of long-term cryopreserved UCB, as well as key data to optimise the clinical transplantation strategy of UCB and expand its application.
Please see the detailed description in following content
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
For the Aspirin arm, 30mg/tablet of the antioxidant substance radicicolothionein for oral administration, 2 tablets each time, three times a day; unrelated umbilical cord
Institute of Hematology, Blood Diseases Hospital
Tianjing, China
RECRUITINGAssessment of the occurrence of adverse events, including non-haematological adverse events of grade 3 or higher
Based on CTCAE (Common Terminology Criteria for Adverse Events) grading, determine the need for dose reduction or suspension of medication; observe the incidence of transplant-related complications acute GVHD, the incidence of infections, the transplant-related mortality Rate (TRM)
Time frame: 2 months post-transplant
Time to neutrophil recovery after UCBT
Blood routine test
Time frame: 3 months post-transplant
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