Бемданепроцел

Rec. INN (наименование, зарегистрированное ВОЗ)

allogenic dopaminergic neural progenitor cells derived from the WA09 human embryonic stem cell (hESC) working cell bank (WCB). The cells are expanded and differentiated on plates coated with a basement membrane extract. Cells are initially grown in a xeno-free and feeder-free medium supplemented with a Rho-associated protein kinase (ROCK) inhibitor. The cells are then replated into polyornithine, laminin, and fibronectin coated flasks to undergo multiple maturation/differentiation steps in neurobasal media containing: bone morphogenetic protein (BMP) inhibitor, anaplastic lymphoma kinase (ALK) inhibitor, sonic hedgehog, glycogen synthase kinase (GSK) 3 inhibitor, brain-derived neurotrophic factor (BDNF), glial cell line-derived neurotrophic factor (GDNF), cAMP, transforming growth factor beta-3 (TGFB3), and a γ- secretase inhibitor. The major cell population consists of midbrain dopamine neuron progenitor cells indicated by the dopamine neuron precursor marker forkhead box protein A2 (FOXA2, >85%), the midbrain dopamine cell markers LIM homeobox transcription factor 1-alpha (LMX1A; <20.95 quantification cycle (Cq)) and pituitary homeobox 3 (PITX3; <28.23 Cq) and the dopaminergic cell marker tyrosine hydroxylase (TH; <24.70 Cq). The final substance also contains a minor cell population of forebrain cells (paired box protein (PAX6); <5%), but no detectable pluripotent stem cells indicated by the absence of the homeobox protein NANOG (<0.2%) and low levels of the octamer-binding transcription factor 4 (OCT4; >26.95 Cq).

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