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

NCT ID: NCT07297576

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-22
• Study Completion Date: 2027-06-30

Brief 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.

Detailed Description

Please see the detailed description in following content

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Sulforaphane

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Sulforaphane

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fang Dong

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology & Blood Diseases Hospital, Tianjin, China

Locations

Institute of Hematology, Blood Diseases Hospital

Tianjing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zimin Sun

Role: CONTACT

Phone: 86+136 0551 8126

Email: sunzimin@ihcams.ac.cn

Facility Contacts

Zimin Sun

Role: primary

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IIT2025085

Identifier Type: -

Identifier Source: org_study_id