Severe Aplastic Anemia (SAA)Severe Aplastic Anemia, RefractorySevere Aplastic Anemia
Investigational drug(s) / intervention(s)
3D hypoxia-preconditioned UC-MSC group2D UC-MSC group
3D hypoxia-preconditioned UC-MSC group: 5 × 10⁵/kg 3D hypoxia-preconditioned UC-MSCs at 4 h before HSC infusion
2D UC-MSC group: 5 × 10⁵/kg 2D UC-MSCs at 4 h before HSC infusion
Study summary
Efficacy and Safety of Sequential Infusion of Hypoxic 3D-Cultured Umbilical Cord Mesenchymal Stem Cells in Haploidentical Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia: A Multicenter, Randomized, Phase 1 Trial
Eligibility
Sex
ALL
Min age
6 Years
Max age
60 Years
Healthy volunteers
No
The inclusion criteria were (1) age 6 to 60 years; (2) diagnosis of SAA or very SAA according to the International Aplastic Anemia Study Group\[21\]; (3) without any severe pulmonary, cardiac, liver, or renal diseases or any active infection; and (4) adequate performance status (Eastern Cooperative Oncology Group score 0-2). Exclusion Criteria：(1)Age 6 years or \> 60 years; (2)Failure to meet the IAASG-defined diagnosis of SAA/vSAA, or confirmed (3)Fanconi anemia, congenital aplastic anemia (e.g., dyskeratosis congenita, Diamond-Blackfan anemia); (4)Presence of severe pulmonary, cardiac, hepatic, or renal insufficiency; Uncontrolled active infection; (5)Eastern Cooperative Oncology Group (ECOG) performance status score ≥ 3.
Primary outcome measure(s)
Adverse events — The incidence and severity of adverse events (AEs) within the first 150 days after haplo-HSCT
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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