Study Comparing Haploidentical Stem Cell Transplantation With and Without Unrelated Cord Blood for Treating Aplastic Anemia

What this Trial Is About

Aplastic anemia AA is a disorder where the bone marrow fails, leading to low blood cell counts due to a reduction in stem cells. This condition involves complex causes including immune problems and stem cell deficiencies. The study compares two types of stem cell transplantation treatments for AA, focusing on safety and effectiveness, especially in patients lacking matched donors for traditional transplants. Participants will receive either haploidentical hematopoietic cell transplantation combined with unrelated cord blood stem cells haplo-cord HCT or haploidentical hematopoietic cell transplantation alone haplo HCT. Treatments include specific conditioning regimens with busulfan and cyclophosphamide before transplant, followed by infusions of stem cells on day 0. Medication to prevent graft-versus-host disease and infections is given before and after transplantation. During the study, patients will be monitored for survival, blood cell recovery, disease-free survival, graft-versus-host disease, and viral reactivations for one year after transplantation. Researchers will assess donor cell presence and immune recovery. The study involves regular clinical assessments and follows patients to measure treatment outcomes and safety. The trial is sponsored by The First Affiliated Hospital of Soochow University and will run until 2028.

A Multicenter, Randomized, Open-Label Study of Haplo-Cord HSCT for the Treatment of Aplastic Anemia