Evaluating Coenzyme I for Hematopoietic Recovery After Cord Blood Transplantation
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
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 |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Anhui Provincial Hospital Government |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT06558253 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with hematological malignancies who are receiving their first single-unit unrelated cord blood transplantation.
Not a fit: Patients with severe organ dysfunction, active infections, or those who refuse the treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients undergoing cord blood transplantation.
How similar studies have performed: While this approach is novel, similar studies have shown promise in enhancing recovery after hematopoietic procedures.
Eligibility criteria
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 this trial is running
Hefei, Anhui
- 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 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.