RecruitingNot ApplicableNCT07297576

Safety and Feasibility of Sulforaphane to Promote Early Haematopoietic Recovery After Cord Blood Transplantation

Safety and Feasibility of Sulforaphane to Promote Early Haematopoietic Recovery After Cord Blood Transplantation A Single-arm, Open, Single-centre Clinical Study


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

36 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a natural compound called sulforaphane (found in cruciferous vegetables like broccoli) can help the blood-forming system recover more quickly after a cord blood stem cell transplant in patients with high-risk blood cancers. **You may be eligible if...** - You are 18 or older - You have a high-risk blood cancer such as AML, ALL, or high-risk MDS - You are in reasonably good health (Karnofsky score at least 70%) - You are receiving a cord blood transplant from a partially matched donor **You may NOT be eligible if...** - Your cancer is low-risk or not included in the study's categories - Your overall health or organ function does not meet the required levels - You are pregnant or breastfeeding - You are receiving a different type of stem cell transplant (not cord blood) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTSulforaphane

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


Locations(1)

Institute of Hematology, Blood Diseases Hospital

Tianjing, China

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NCT07297576


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