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Amustaline-treated red blood cells (RBCs) are a pathogen-reduced blood product developed by Cerus Corporation using the INTERCEPT Blood System. The system utilizes amustaline (S-303), a small molecule bifunctional alkylating agent, in combination with glutathione (GSH) to inactivate a broad spectrum of viruses, bacteria, parasites, and leukocytes in red blood cell concentrates. Amustaline works by intercalating into the helical regions of nucleic acids and forming permanent covalent cross-links, thereby preventing the replication, transcription, and translation of pathogen DNA and RNA. This technology is designed to enhance the safety of chronic blood transfusions in patients with conditions such as thalassemia major by reducing the risk of transfusion-transmitted infections and transfusion-associated graft-versus-host disease. The SPARC Phase 3 study evaluated the efficacy and safety of these treated RBCs in patients with thalassemia major requiring chronic transfusion support.
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