With the standard of human embryonic stem cells in place, cells are expected to become "living drugs"

On February 26, the Chinese society of cell biology issued the standard of human embryonic stem cells, which is the first product standard for embryonic stem cells in China and even in the world Stem cells and their cell products are not recognized as drugs for a long time due to their heterogeneity, activity changes and other special properties, and they are considered to be difficult to "control" and scale application in clinical application 125 human embryonic stem cell lines have been tested in 38 laboratories around the world, and it is found that they may have genetic mutations in inappropriate in vitro culture; at the same time, according to the requirements of the food and Drug Administration (FDA), even the stem cell lines registered in the National Institutes of Health (NIH) of the United States can not meet the requirements of clinical application Therefore, the biggest puzzle in the field of international stem cell research and clinical application is: what kind of stem cells can be used in clinical and pharmaceutical applications, which is the question to be answered by the standards of embryonic stem cells released this time "After more than ten years of efforts, Beijing stem cell bank has reached the ISO quality management system certification standard and established more than 300 human embryonic stem cell lines, which can meet the demand of 70% immunomatching With the efforts of the standard working group of stem cell branch of society of cell biology, it has written a paper on the experience accumulated in cultivating clinical stem cell lines in the past ten years, and has won the international and domestic peers Yes " Zhao Tongbiao, a researcher at the Institute of stem cell and regenerative medicine innovation of the Chinese Academy of Sciences, said that a lot of practical work has become the basis for the formation of group standards Therefore, for "living" cells, standardized technical requirements, test methods and strict quality control will help them meet the clinical requirements On the other hand, with the increasing clinical demand of stem cells, stem cell research projects are accelerating According to reports, in recent years, the clinical transformation work of stem cell research in China has carried out 4 batches and 35 projects "We are often asked how stem cell projects should be quality controlled." Wu Chaohui, Secretary General of China Pharmaceutical Biotechnology Association, said Due to different sources, various types and complex functions, stem cells differ greatly in preparation process, quality control means, application mode, indication selection, etc., so it is urgent to establish a unified standard to promote the better development of clinical research and clinical trials "Cells have their own characteristics, but if the dose and concentration of each injection are different, how to evaluate its efficacy?" Wei Wenbin, vice president of Tongren Hospital, said that products moving towards clinical practice must pass standardized tests, and standards are the first step "The standard is to standardize, strictly comply with ethical requirements, and standardize the clinical research of the whole stem cell." Zhou Qi, academician of the Chinese Academy of Sciences and director of the Institute of zoology of the Chinese Academy of Sciences, said that there is no precedent for stem cell standards in the world at present The group standards of embryonic stem cells will play an important role in innovation leading and guiding industrial development, and will provide basis for strengthening supervision and management of national administrative departments and establish norms for scientific research "The stem cell industry will surely transition to the stage of standardized production and large-scale preparation to realize the production of clinical application products that can be supervised, repeated and verified, and cannot stay in the stage of clinical research that cannot prove the safety and effectiveness." According to Zhou Qi, embryonic stem cells may become the most important raw materials in the field of stem cell drug research and development in the future, which means that "standards first" is needed With the refinement of standard setting, the deepening of basic research and the advancement of clinical research, cell products will also have the characteristics of homogeneity and stability when they enter the clinic According to reports, the group standard of human embryonic stem cells is the latest standard of stem cells issued by stem cell standard working group of society of cell biology after the first standard of stem cells, general requirements for stem cells, was released in 2017 Next, the working group will further refine the special standard and complete the standard formulation of cell types differentiated by embryonic stem cells in clinical application, such as retina To establish the standard of cell-like and cardiac cell-like, and guide the clinical research and application.