Умитрелиморген аутоденцел

Rec. INN (наименование, зарегистрированное ВОЗ)

autologous dendritic cells (DCs) derived from peripheral blood mononuclear cells (PBMCs) obtained from newly diagnosed glioblastoma multiforme patients by apheresis, loaded with two messenger ribonucleic acids (mRNA) encoding (i) human lysosome- associated membrane protein 1 (LAMP 1) fused in frame to codon-optimised human cytomegalovirus (hCMV) 65 kDa matrix protein (pp65) (LAMP:pp65) and (ii) amino acids 21-261 of codon-optimised CD-40 ligand (CD-40L M21). Each mRNA also contains a 5' cap (cap 0), a Kozak sequence and a 3' polyadenylation tail., The cells are expanded in selective growth media containing granulocyte-macrophage colony-stimulating factor (GM-CSF) and interleukin 4 (IL-4). Prior to the electroporation, the cells are briefly cultured in a maturation media containing TNF-alpha, interferon- gamma (IFN-γ) and prostaglandin E2 (PGE2).
The cell suspension contains ≥60% dendritic cells (HLA-DR) and ≤10% each of T lymphocytes (CD3), B lymphocytes (CD19), natural killer cells (CD56) and monocytes (CD14). In a co-culture assay with T lymphocytes from the same patient the cells release IFN-γ.

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