NCT06650553 Umbilical Cord Blood-Supported Haplo-HSCT for Aplastic Anemia Treatment Study
| NCT ID | NCT06650553 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanxi Bethune Hospital |
| Condition | Aplastic Anemias |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2024-06-01 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Aplastic anemia (AA) is a rare bone marrow failure syndrome with an annual incidence of about 0.74/100,000, affecting all ages but more common in the elderly. It's divided into congenital and acquired forms, with the latter being more prevalent. The primary acquired form is linked to T lymphocyte activation and genetic factors. The best treatment is allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a near 90% cure rate. Sibling allo-HSCT is ideal but finding a match is challenging. For those who relapse after immunosuppressive therapy, haploidentical HSCT is a viable option despite risks like graft failure and GVHD. Advances in transplantation have made haplo-HSCT's efficacy comparable to other methods. Recent studies suggest co-transplantation with umbilical cord blood cells can improve outcomes by hastening hematopoietic recovery and prognosis. Our study will evaluate the feasibility and safety of this approach in AA treatment, comparing it to sibling fully matched transplantation, with a focus on infection rates, GVHD incidence, TRM, and EFS, aiming to enhance treatment practices and benefit patients and the medical industry.
Eligibility 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)
Contact & Investigator
Tao Wang, Dr.
STUDY DIRECTOR
Shanxi Bethune Hospital Regulatory Authority
Frequently Asked Questions
Who can join the NCT06650553 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 75 Years, studying Aplastic Anemias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06650553 currently recruiting?
Yes, NCT06650553 is actively recruiting participants. Contact the research team at wangtao99699@163.com for enrollment information.
Where is the NCT06650553 trial being conducted?
This trial is being conducted at Taiyuan, China.
Who is sponsoring the NCT06650553 clinical trial?
NCT06650553 is sponsored by Shanxi Bethune Hospital. The principal investigator is Tao Wang, Dr. at Shanxi Bethune Hospital Regulatory Authority. The trial plans to enroll 110 participants.