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This document specifies the ethical requirements, technical requirements, and testing methods, inspection rules, usage instructions, labeling, transportation, and storage for human gastric organoids.
This standard applies to the production and test of human gastric organoids derived from human gastric epithelial tissue and human pluripotent stem cells.
Normative references
The following referenced documents are indispensable for the application of these documents. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including all amendments) applies.
Pharmacopoeia of the People’s Republic of China (2020 Edition, Part III).
Terms and definitions
The following terms and definitions apply to this document.
Organoids
Three-dimensional (3D) structures that grow from stem cells or progenitor cells in vitro, are capable of self-organization and renewal, consist of organ-specific cell types and can mimic the in vivo architecture and specific function of the original tissue (Clevers 2016; Fujii and Sato 2021; Kim et al. 2020; Wang et al. 2023).
Human gastric organoids
Organoids that develop from human gastric stem cells of normal tissue or pluripotent stem cells, possess a variety of mature gastric epithelial cell types (Bartfeld et al. 2015; McCracken et al. 2017; McCracken et al. 2014).
Organoid passage
Process of dissociating existing organoids into smaller fragments, or single cell via physical, chemical, or biological methods, and keeping them growing in vitro under the same culture conditions (Bartfeld et al. 2015).
Organoid cryopreservation
Freezing process by which organoids are maintained at low temperature in an inactive state for maintaining cellular composition, gene expression, and functional properties.
Organoid thawing
Process of bringing frozen organoids from an inactive to an actively growing state.
Gastric stem cells
Cells that can self-renew and possess the ability to differentiate into all types of gastric epithelial cells (Barker et al. 2010; Kim and Shivdasani 2016; McCracken et al. 2017; Mills and Shivdasani 2011; Tan et al. 2020).
Gastric stem cell differentiation
Process of gastric stem cells dividing into their daughter cells, including surface mucous cells, parietal cells, chief cells, mucous neck cells and enteroendocrine cells, et al. (McCracken et al. 2017; Wolffling et al. 2021).
Gastric proliferative cells
Cells that are initially derived from gastric stem cells, characterized by high proliferative capacity and the ability to differentiate into various mature...