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NCT07885982
Conditioning Regimen Containing Low-Dose ATG for the Treatment of AA Receiving sUCBT
Conditions: Aplastic Anaemia
Sex: All
Ages: 1 Year – 50 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 59
Sponsor: Anhui Provincial Hospital
Location: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) Hefei Anhui
Summary
To evaluate the safety and efficacy of Single Umbilical Cord blood transplantation (sUCBT) containing low dose ATG based conditioning regimen in the treatment of Aplastic Anemia (AA)
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of severe aplastic anemia (SAA) according to the Camitta criteria, transfusion-dependent non-severe aplastic anemia (TD-NSAA), or inherited bone marrow failure syndrome (IBMFS) with an indication for allogeneic hematopoietic stem cell transplantation (HSCT).
* Age 1 to 50 years, regardless of sex.
* No available HLA-matched sibling donor or 10/10 HLA-matched unrelated donor.
* Eligible for single-unit unrelated umbilical cord blood transplantation (UCBT) using a cord blood unit that meets the protocol-defined HLA matching and minimum cell dose requirements.
* Negative donor-specific anti-HLA antibodies (DSA) against the selected cord blood unit before transplantation.
* Adequate cardiac, hepatic, renal, and pulmonary function.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score 0-2.
* Serum ferritin \
Source: ClinicalTrials.gov (NCT07885982). StuddyBuddy aggregates publicly available trial information.