CClinicalTrials.gg
RecruitingNCT07297576Updated Dec 30, 2025

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

An interventional study of Sulforaphane in ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myelogenous Leukemia and MDS (Myelodysplastic Syndrome), sponsored by Institute of Hematology & Blood Diseases Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-30.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Please see the detailed description in following content

02

Conditions studied

  • ALL (Acute B-Lymphoblastic Leukemia)
  • AML (Acute Myelogenous Leukemia
  • MDS (Myelodysplastic Syndrome)
03

In context

Leukemia, Myeloid, Acute

2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.

This study's planned enrollment of 36 is below the median of 41 across 2,509 interventional studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with high-risk haematological malignancies: including AML, ALL, high-risk MDS
  2. Age: ≥18 years
  3. Karnofsky score ≥70%, Eastern Cooperative Oncology Group (ECOG) physical status ≤2 points
  4. Selection of non-haematopoietic cord blood: donor-recipient HLA high-resolution compatibility ≥4/6, 7/10 and CD34 cells ≥0.83×105/kg (recipient's body weight), meeting the above criteria, only cord blood with a freezing time of ≥10 years can be found in China's public umbilical cord blood stem cell banks.

Exclusion criteria

Exclusion criteria:

  1. Patients who test positive for the following pathogens: HIV (HIV-1/2), human cytomegalovirus (HCMV-DNA), EBV (EBV-DNA), Hepatitis B (positive for Hepatitis B Surface Antigen (HBsAg) or Hepatitis B DNA (HBV-DNA)), Hepatitis C Antibody (HCV-Ab), Treponema pallidum Antibody (TP-Ab).
  2. Active bacterial, viral, fungal or parasitic infections of clinical significance as judged by the investigator at the time of screening
  3. Willing donors with full HLA compatibility and eligible for allogeneic haematopoietic stem cell transplantation
  4. Previous gene therapy or allogeneic haematopoietic stem cell transplant recipients
  5. Immediate family members with known or suspected familial cancer syndromes (including but not limited to hereditary breast and ovarian cancer syndromes, hereditary non-polyposis colorectal cancer syndromes, familial adenomatous polyposis, etc.)
  6. Confirmed diagnosis of a major mental illness or predisposition to mental illness that would seriously affect the ability to participate in clinical research
  7. History of major organ injury, including: Liver lesions: liver function tests suggesting AST or ALT > 3 × ULN; total serum bilirubin > 2.5 × ULN; total bilirubin > 3 × ULN and direct bilirubin > 2.5 × ULN if consistent with Gilbert's syndrome; history of hepatic pontine fibrosis, cirrhosis, and the presence of active hepatitis; Cardiac lesions: left ventricular ejection fraction ("LVEF") \< 45%; New York Heart Association (NYHA) class III or IV congestive heart failure (see Appendix 1 for classifications of heart failure); severe heart failure requiring treatment. Cardiac pathology: left ventricular ejection fraction (LVEF) \<45%; New York Heart Association (NYHA) class III or IV congestive heart failure (see Appendix 1 for NYHA heart failure classification); severe arrhythmia requiring treatment; uncontrolled hypertension or unstable angina; myocardial infarction or bypass or stent surgery within 12 months prior to enrolment; clinically significant valvular disease; calculated eGFR \<60mL/min/1.73m2 and direct bilirubin >1.73m2; history of hepatic bridging fibrosis and cirrhosis; and presence of active hepatitis. Lung function: FEV1/FVC \<60% and/or diffusion function \<60% of predicted value; clinically significant evidence of pulmonary hypertension requiring medical intervention.
  8. Uncorrectable coagulation disorders or history of severe bleeding disorders
  9. Any other condition that, in the opinion of the doctor, makes the subject unsuitable for haematopoietic stem cell transplantation
  10. Known allergy to the test drug or ingredients
  11. Have participated or are participating in other interventional clinical studies within 3 months prior to screening
  12. Live vaccination within 6 weeks prior to screening
  13. Pregnant or breastfeeding women
  14. Subjects did not follow the study protocol well
  15. Any other condition deemed by the investigator to be unsuitable for participation in this clinical trial
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Test group

    For the Aspirin arm, 30mg/tablet of the antioxidant substance radicicolothionein for oral administration, two tablets each time, three times a day; unrelated umbilical cord

    Dietary Supplement: Sulforaphane

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

06

What researchers measure

Primary outcomes

  1. Assessment 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

  2. Time to neutrophil recovery after UCBT

    Blood routine test

    Time frame: 3 months post-transplant

07

Study locations

1 of 1 sites recruiting
  • Institute of Hematology, Blood Diseases Hospital
    Tianjing, China
    Recruiting
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 7, 2025
  • Informed consent form · Jul 7, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07297576
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Responsible party
Sponsor
First posted
Dec 22, 2025
Start date
Oct 22, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Dec 30, 2025

Study contacts

Zimin Sun
Contact
sunzimin@ihcams.ac.cn
86+136 0551 8126
Fang Dong
principal investigator · Institute of Hematology & Blood Diseases Hospital, Tianjin, China

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion