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Dilanubicel is a universal donor, off-the-shelf, ex vivo expanded hematopoietic stem and progenitor cell (HSPC) therapy derived from pooled donor umbilical cord blood CD34+ cells. When administered following intensive chemotherapy (such as fludarabine, cyclophosphamide, and thiotepa), it acts as a non-engrafting adjuvant cell therapy to provide rapid, transient hematopoiesis and long-term immunologic benefits. The therapy is designed to enhance remission rates and improve overall survival in patients with acute myeloid leukemia (AML) and other hematologic malignancies by reducing the period of severe neutropenia and infection risk. Dilanubicel has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation, Orphan Drug Designation (ODD), and Fast Track designation for the treatment of newly diagnosed AML.
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