Using umbilical cord blood to support stem cell transplants for treating aplastic anemia
Clinical Study on Umbilical Cord Blood-Supported Haploidentical Hematopoietic Stem Cell Transplantation for the Treatment of Aplastic Anemia
This study is testing if using umbilical cord blood can improve stem cell transplants for people with aplastic anemia compared to traditional donor matches.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 6 Years to 75 Years |
| Sex | All |
| Sponsor | Shanxi Bethune Hospital Academic / other |
| Locations | 1 site (Taiyuan, Shanxi) |
| Trial ID | NCT06650553 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of using umbilical cord blood in haploidentical hematopoietic stem cell transplantation (haplo-HSCT) for patients with aplastic anemia. Participants will be divided into two groups: one receiving traditional HLA-matched HSCT and the other receiving the umbilical cord blood-supported haplo-HSCT. The goal is to compare outcomes, particularly hematopoietic recovery and overall prognosis, between the two approaches. Aplastic anemia is a serious condition, and this innovative method aims to improve treatment options for patients who struggle to find matched donors.
Who should consider this trial
Good fit: Ideal candidates are patients aged 14-70 diagnosed with severe aplastic anemia or transfusion-dependent non-severe aplastic anemia who are suitable for allogeneic hematopoietic stem cell transplantation.
Not a fit: Patients with significant vital sign abnormalities or other conditions deemed unsuitable for the trial by investigators may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more accessible and effective treatment option for patients with aplastic anemia.
How similar studies have performed: While haploidentical HSCT has shown promise in other studies, the specific combination with umbilical cord blood is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A patient age of 6-75 years * Patients diagnosed with Severe Aplastic Anemia (SAA) , Transfusion-Dependent Non-Severe Aplastic Anemia (TD-NSAA) or Paroxysmal nocturnal hemoglobinuria (PNH) acquired clonal-aplastic anemia(AA) according to the Chinese Guidelines for the Diagnosis and Treatment of Aplastic Anemia (2022 Edition) and suitable for allo-HSCT * Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Exclusion Criteria: * Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * Patients with any conditions not suitable for the trial (investigators' decision)
Where this trial is running
Taiyuan, Shanxi
- Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Recruiting)
Study contacts
- Study coordinator: Tao Wang, Dr.
- Email: wangtao99699@163.com
- Phone: 13835175119
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.