The spring of China's national policy in clinical cell (somatic cell) therapy for neurorestoration

The clinical cell (somatic cell) therapy of neurorestoration started at the beginning of this century, and olfactory ensheathing cell therapy for chronic complete spinal cord injury achieved a neurorestorative therapeutic breakthrough of "0" to "1" over thousands of years. Some patients recover from lost nervous functions and are able to stand as well as walk again with the assistance of orthosis or a walking stick. This opens a large curtain for the deeper exploration of clinical cell therapy of neurorestoration 1 , 2 , 3 , 4 . This article focuses on the introduction of development and changes of management policies for the application of somatic cells in China, especially on the key points of the Regulations on Clinical Research and Clinical Translation Application Management of Biomedical New Technologies issued by the State Council of the People's Republic of China (No.818) [5] .

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Publication Details

Journal
Journal of Neurorestoratology
Published
2026-01-09
DOI
https://doi.org/10.1016/j.jnrt.2026.100267
Primary Topic
Biomedical Ethics and Regulation
Type
article
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article

The spring of China's national policy in clinical cell (somatic cell) therapy for neurorestoration

Hongyun Huang
Journal of Neurorestoratology
Biomedical Ethics and Regulation
article

The spring of China's national policy in clinical cell (somatic cell) therapy for neurorestoration

Hongyun Huang
article en

Abstract

The clinical cell (somatic cell) therapy of neurorestoration started at the beginning of this century, and olfactory ensheathing cell therapy for chronic complete spinal cord injury achieved a neurorestorative therapeutic breakthrough of "0" to "1" over thousands of years. Some patients recover from lost nervous functions and are able to stand as well as walk again with the assistance of orthosis or a walking stick. This opens a large curtain for the deeper exploration of clinical cell therapy of neurorestoration 1 , 2 , 3 , 4 . This article focuses on the introduction of development and changes of management policies for the application of somatic cells in China, especially on the key points of the Regulations on Clinical Research and Clinical Translation Application Management of Biomedical New Technologies issued by the State Council of the People's Republic of China (No.818) [5] .

Journal of NeurorestoratologyVol. 14(1)
Henan Psychiatric Hospital (CN), First Affiliated Hospital of Xinxiang Medical University (CN), Taian City Central Hospital (CN), Henan Medical University (CN)
Openalex Percentile: Top 93%
Biomedical Ethics and Regulation
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