Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07297576

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

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-12-30

36

Participants Needed

1

Research Sites

83 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with high-risk hematological malignancies including AML, ALL, or high-risk MDS
  • Age 18 years or older
  • Karnofsky performance score of 70% or higher and ECOG physical status of 2 or less
  • Use of non-hematopoietic cord blood with donor-recipient HLA compatibility of at least 4/6 or 7/10 and CD34 cell dose of at least 0.83 x 10^5/kg body weight from cord blood frozen for 10 years or more in China's public cord blood banks
Not Eligible

You will not qualify if you...

  • Positive test for HIV-1/2, human cytomegalovirus, EBV, hepatitis B or C, or Treponema pallidum antibodies
  • Active significant bacterial, viral, fungal, or parasitic infections at screening
  • Availability of fully HLA-matched donors eligible for allogeneic stem cell transplantation
  • Previous gene therapy or allogeneic stem cell transplant recipients
  • Immediate family members with known or suspected familial cancer syndromes
  • Major mental illness or predisposition affecting ability to participate
  • History of major organ damage including significant liver, heart, lung, or kidney disease
  • Uncorrectable coagulation disorders or severe bleeding history
  • Known allergy to sulforaphane or its ingredients
  • Participation in other interventional clinical trials within 3 months prior to screening
  • Live vaccination within 6 weeks prior to screening
  • Pregnant or breastfeeding women
  • Poor compliance with study protocol
  • Other conditions deemed unsuitable by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Institute of Hematology, Blood Diseases Hospital

Tianjing, China

Actively Recruiting

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Research Team

Z

Zimin Sun

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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