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The Cell-based Medicinal Product used for transplantation originated from non-immortalized hf NPCs (BI-0194-008 cell line) obtained from the telencephalon and diencephalon of a single 10-12 weeks post-conception (WPC) human fetus, after elective pregnancy termination. hf NPCs were in vitro expanded and underwent quality control tests. The safety profile of the hf NPC cell line was tested in vivo in CD-1 mice immunosuppressed via cyclosporin. Medicinal product manufacturing and release were performed according to GMP conditions.

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