Sulforaphane to speed blood‑cell recovery after long‑frozen cord‑blood transplant
Safety and Feasibility of Sulforaphane to Promote Early Haematopoietic Recovery After Cord Blood Transplantation A Single-arm, Open, Single-centre Clinical Study
This trial tries sulforaphane to see if it helps adults with high‑risk AML, ALL, or MDS recover blood cells faster after receiving cord blood units frozen for 10 years or more.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 1 site (Tianjing) |
| Trial ID | NCT07297576 on ClinicalTrials.gov |
What this trial studies
Umbilical cord blood units frozen long term can show impaired stem/progenitor cell function and slower blood-count recovery after transplant. Laboratory work in immunodeficient animals suggested the antioxidant sulforaphane can partially rescue mitochondrial and functional damage caused by prolonged freezing. This single‑center interventional trial will give sulforaphane to adult patients receiving selected public cord blood units with ≥10 years of storage and monitor safety, timing of neutrophil and platelet engraftment, and early hematopoietic recovery. The study is designed to test feasibility and collect clinical safety and engraftment data to inform larger trials.
Who should consider this trial
Good fit: Adults (≥18 years) with high‑risk AML, ALL, or high‑risk MDS who are planned for cord blood transplantation using a public cord blood unit with ≥10 years of freezing, adequate HLA match and CD34 dose, and who have good performance status and no excluded infections are ideal candidates.
Not a fit: Patients with active bacterial/viral/fungal infections or positive tests for HIV, HBV, HCV, CMV, EBV, or syphilis, those who cannot receive qualifying long‑frozen cord blood units, or those with poor performance status are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, sulforaphane could shorten the time to blood‑cell recovery after cord blood transplant, potentially lowering infection risk and hospital stays.
How similar studies have performed: Preclinical studies in immunodeficient animals showed partial rescue of frozen cord blood cell function with sulforaphane, but this approach has not yet been tested in human clinical trials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tianjing
- Institute of Hematology, Blood Diseases Hospital — Tianjing, China (Recruiting)
Study contacts
- Principal investigator: Fang Dong — Institute of Hematology & Blood Diseases Hospital, Tianjin, China
- Study coordinator: Zimin Sun
- Email: sunzimin@ihcams.ac.cn
- Phone: 86+136 0551 8126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.