Evaluating Coenzyme I for Hematopoietic Recovery After Cord Blood Transplantation
Official title: An Exploratory Study to Assess the Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery After Single-unit Unrelated Cord Blood Transplantation in Patients With Hematological Malignancies
Run by Anhui Provincial Hospital · NCT06558253 · Data updated 2026-11-12
This study is testing if a new injection called coenzyme I can help people recover better after receiving a cord blood transplant for blood cancers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Anhui Provincial Hospital Government |
| Locations | 1 site (Hefei, Anhui) |
| Status | Recruiting |
| Started | November 29, 2024 |
| Main results expected | April 1, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | December 18, 2024 |
| Trial ID | NCT06558253 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 60 with hematological malignancies who are receiving their first single-unit unrelated cord blood transplantation.
✕Probably not a fit
Patients with severe organ dysfunction, active infections, or those who refuse the treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study assesses the safety and efficacy of coenzyme I for injection in promoting hematopoietic recovery in patients undergoing single-unit unrelated cord blood transplantation for hematological malignancies. It is a single-center, open-label, dose-escalation study that aims to determine how well this treatment works in facilitating recovery after transplantation. Participants will be monitored for safety and effectiveness as they receive the intervention.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients undergoing cord blood transplantation.
How similar studies have gone: While this approach is novel, similar studies have shown promise in enhancing recovery after hematopoietic procedures.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 60 years (inclusive) at screening; gender is not restricted; * Diagnosed with hematological malignancies to receive sUCBT for the first time; * No severe organ failure and no active infections * ECOG performance status of 0-2; * Voluntarily participating in the clinical trial, with full understanding of the trial details and having signed the informed consent form. Exclusion Criteria: * Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas; * Pregnant patients; * Patients and/or authorised family members who refuse to receive Coenzyme I for Injection; * Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise patient safety and put the results of the study at undue risk; drug-dependent individuals; patients with uncontrolled psychiatric disorders; and individuals with cognitive impairment; * Participants in other clinical studies affecting hematopoietic recovery within 3 months; * Those who are considered by the investigator to be unsuitable for enrolment (e.g., those who anticipate that the patient will not be able to adhere to the examination and treatment due to financial or other issues).
Where it's running
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The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China Recruiting
Study contacts
- Principal investigator: Xiaoyu Zhu, Ph.D — The First Affiliated Hospital of University of Science and Technology of China
- Study coordinator: Xiaoyu Zhu, Ph.D
- Email: xiaoyuz@ustc.edu.cn
- Phone: 15255456091
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.