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The number of clinical trials for mesenchymal stem cell (MSC) products ranked the top among all stem cell products, with more than 900 trials ongoing or completed by 2018. In China, many MSC clinical trials have started as "the third type of medical technique" and the dossiers of MSC products have been submitted to National Medical Products Administration (NMPA). The biological function and therapeutic effect of MSCs are constantly being recognized in scientific communities. However, the observed functions of MSCs in vitro are not fully reproduced in the living microenvironment in vivo. There are substantial variations among tissue origins, cellular phenotypes and biological functions. Different formulations, delivery methods, manufacture processes or doses all greatly affect the clinical efficacy. It is difficult for MSCs to maintain the naive state due to the differences between in vitro culture conditions and in vivo microenvironment. Meanwhile, there is no widely accepted scientific definition for MSCs until now, due to the complexity of manufacturing process and variable sources. Consequently, the regulation of MSC products is a challenge for drug administrative agencies. In this article, we review the research progress of MSC products around the world, and summarize the considerations in evaluating the chemistry, manufacturing and controls (CMC) section of MSC product applications, with respect to raw materials, manufacture processes and quality control. We hope that the information summarized here will provide insights for the development and evaluation of MSC products.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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