Stem cells have the potential of self-renewing and multilineage differentiation. Different types of stem cells have different advantages and limitations. It has become a hot topic of basic research and clinical application. Currently human-derived stem cell products to be developed as drugs come mainly from adult stem cells, embryonic stem cells, and induced pluripotent stem cells. Human-derived stem cell products are complex and diverse, showing unique therapeutic advantages in the treatment of a variety of diseases. This paper summarizes the characteristics and the latest research progress of human-derived stem cell products. According to the drug development and evaluation rules, this article brings up some quality assessment concerns and discussions in the major fields, such as raw materials, manufacturing process, quality research and control, stability, packaging container system, for the industry and regulators to discuss and communicate, expecting to promote the clinical transformation and application of this class of products.
| 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 |