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Outline
This article aims to provide a reference for the dynamic regulatory oversight of clinical trials of stem cell drugs and the enhancement of pharmacovigilance practices.
Using data from the Drug Clinical Trial Registration and Information Disclosure Platform and the Pharmacovigilance Database of the Center for Drug Evaluation of the National Medical Products Administration, we conducted a retrospective analysis of the progress of domestic registered clinical trials for stem cell drugs and of individual case safety reports on suspected unexpected serious adverse reactions (SUSAR).
As of June 30, 2025, a total of 134 Investigational New Drug (IND) applications for stem cell drugs have been approved in China, and 113 registered clinical trials are recorded on the registration platform. From January 2021 to June 2025, a total of 29 domestic SUSAR reports were received, with adverse reactions mainly involving systemic disorders and administration site reactions, as well as respiratory disorders.
Registered clinical trials of stem cell drugs in China have shown a steady development trend in recent years. Sustained attention must be paid to the long-term potential safety risks of stem cells to safeguard the safety of clinical trials.
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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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