On 26 February 2019, the "Human Embryonic Stem Cells" standard was released in Beijing. This is China's first product standard targeting embryonic stem cells. Taking into account scientific research, clinical practice, industry and sectoral factors, it systematically defines the basic quality attributes of embryonic stem cells, the technical principles for quality control, and the relevant requirements for product use and circulation.
In recent years, China has made important progress in the clinical translation of stem cell research. However, because their sources are varied, their types diverse and their functions complex, stem cells differ widely in preparation processes, quality control methods, application modes and indication selection. There is an urgent need to establish unified standards to better drive the development of clinical research and clinical trials. In view of this, the Stem Cell Biology Branch of the Chinese Society for Cell Biology established a Stem Cell Standards Working Group in 2016, carrying out standard-setting work in a lawful, compliant and orderly manner.
Following the release of the first stem cell standard – the "General Requirements for Stem Cells" – in 2017, the working group convened experts from related fields and, over two years and more than 50 rounds of discussions, formulated a series of standards including the "Human Embryonic Stem Cells" association standard. These standards will play an important role in standardization within the stem cell field, in safeguarding the rights and interests of trial participants, in regulating the development of the stem cell industry and in promoting the translational application of stem cells.
