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- W2786233742 abstract "Objective: To evaluate the safety and immunological effects of antigen specific therapy in Multiple Sclerosis (MS) and Neuromyelitis optica (NMO). Background: Antigen specific tolerogenic dendritic cells therapy has shown efficacy in animal models of MS. However, its safety and efficacy is still not known in humans. Design/Methods: 9 patients (6 MS and 3 NMO patients) have been included in an ascending dose protocol of antigen specific tolerogenic dendritic cells. Dendritic cells were derived from monocytes isolated after leukopheresis and tolerization was induced with dexamethasone. Disease relevant peptides (MOG1–20, MOG35–55, MBP13–32, MBP83–99, MBP111–129, MBP146–170, PLP139–154, for MS and AQP4 63–76 for NMO) were added during tolerization process. Clinical and immunological assessment were performed every two weeks for 3 months. Primary endpoint is safety and secondary endpoints are changes in immunological markers and clinical activity (relapses or changes in disability (EDSS)). Immunological studies include proliferative assays, cytokine production with ELISPOT for IL10, IL17 and IFNg and peripheral cell population dynamics by flow cytometry. Results: No relevant side effects have been observed until now. We have observed a switch for Th2 responses by flow cytometry. ELISPOT assays and proliferation assays indicated an increase in IL10 and decrease in IFNg production. Conclusions: Antigen specific tolerogenic DC therapy seems safe in patients with MS and NMO and immunological support the functional tolerogenic role of the therapy. Disclosure: Dr. Zubizarreta Nafarrate has nothing to disclose. Dr. Florez has nothing to disclose. Dr. Vila has nothing to disclose. Dr. Cabezon has nothing to disclose. Dr. Espana has nothing to disclose. Dr. Benitez has nothing to disclose. Dr. Varea has nothing to disclose. Dr. Arnaiz has nothing to disclose. Dr. Saiz has received personal compensation for consulting services and speaking from Bayer-Schering, Merck-Serono, Biogen Idec, Sanofi-Aventis, Teva Pharmaceutical Industries Ltd and Novartis as a consultant and speaker. Dr. Villoslada has received personal compensation for activities with Roche and Novartis as a consultant." @default.
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- W2786233742 date "2017-04-18" @default.
- W2786233742 modified "2023-10-06" @default.
- W2786233742 title "Phase 1b clinical trial with antigen-specific tolerogenic dendritic in Multiple Sclerosis and Neuromyelitis optica: safety and immunological effects (P2.330)" @default.
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