On February 26, 2019, the “Human Embryonic Stem Cells” standard was released in Beijing. This standard is my country’s first product standard for embryonic stem cells. It comprehensively considers scientific research, clinical, industrial, industry and other factors, and systematically stipulates the basic quality attributes of embryonic stem cells, technical guidelines for quality control, and relevant requirements for product use and circulation.
In recent years, important progress has been made in the clinical translation of stem cell research in my country. However, due to different sources, diverse types, and complex functions, stem cells vary greatly in terms of preparation processes, quality control methods, application methods, and indication selection. It is urgent to establish unified standards to promote better development of clinical research and clinical trials. In view of this, the Stem Cell Biology Branch of the Chinese Society of Cell Biology established a stem cell standards working group in 2016 and carried out standard formulation work in an orderly manner in accordance with the law and regulations.
Following the release of the first stem cell standard – “General Requirements for Stem Cells” in 2017, the working group organized experts in relevant fields and spent two years and more than 50 discussions to formulate a series of standards including the “Human Embryonic Stem Cells” group standard. These standards will play an important role in standardizing the stem cell field, protecting the rights and interests of subjects, standardizing the development of the stem cell industry, and promoting the transformation and application of stem cells.