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With the rapid advancement of stem cell therapy, its application in clinical medicine has expanded significantly, posing new challenges to existing regulatory frameworks. This article systematically reviews the regulatory models for stem cell therapy across multiple countries, and based on a comparative analysis of regulatory policies, technical guidelines, and peer-reviewed literature, summarizes the major approaches and common trends regarding risk stratification, access pathways, and lifecycle quality management. The analysis highlights the widespread adoption of risk-based classification and accelerated access mechanisms to balance efficacy and safety. Through comparative analysis, the article details the evolution of China's regulatory system for stem cell therapy, emphasizing the characteristics of the "dual-track" model-parallel management through drug-based regulation and clinical research filing. In response to current issues such as unclear classification, fragmented oversight, and insufficient international alignment, the article proposes five key strategies: establishing scientific classification standards, improving quality control systems, facilitating clinical translation, strengthening ethical oversight and information transparency, and deepening international cooperation. These recommendations aim to support the development of a scientific, standardized, and efficient regulatory framework with Chinese characteristics, while also offering insights for global regulatory practices.
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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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