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Factor VIII-loaded tolerogenic dendritic cells (tolDCs) are an autologous cell therapy being developed by Cell4Cure AB for the treatment of hemophilia A in patients who have developed inhibitory antibodies (inhibitors) against exogenous Factor VIII. The therapy involves isolating a patient's own monocytes, differentiating them into dendritic cells in vitro, and treating them with immunosuppressive agents (such as dexamethasone and vitamin D3) to induce a tolerogenic phenotype. These cells are then pulsed or loaded with recombinant Factor VIII. When re-administered to the patient via intravenous infusion, these tolDCs are designed to present Factor VIII antigens to T cells in a non-stimulatory context, thereby inducing regulatory T cells (Tregs) and promoting immune tolerance, ultimately reducing or eliminating the inhibitory antibody response.
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