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Induced pluripotent stem cells (iPSCs) have become the leading research object in the clinical application of restorative medicine. They are easily generated from diverse cell sources and functionally indistinguishable from embryonic stem cells without the accompanying ethical issues. To date, the use of iPSC-derived neural stem cells and their progeny in the treatment of neurodegenerative and injurious diseases has achieved good results, with great potential in cell drug development. However, because of some unique biological properties and differences from traditional drug production processes, cell drug research and development has many problems that can hinder clinical applications. Given this situation, the Chinese Association of Neurorestoratology (Preparatory) and China Committee of the International Association of Neurorestoratology have organized relevant professional experts to formulate the standard presented here. Overall, the aim was to promote the clinical application of neural stem cells (NSCs) and their further derived neural cells from iPSC sources and promote cell drugs’ production and development. This standard refers to the latest research results, quality evaluation criteria for traditional medicines, and the regulatory framework for cellular treatments. The standard considers general biological properties of cells, including cell morphology, cell cycle, karyotype, and cell viability. The specific biological properties of NSCs, such as cell surface markers and differentiation ability, general drug standards, such as aseptic testing, endotoxins, human virus detection, and cell-related drug standards, such as telomerase activity and tumorigenicity, are also considered. This standard will serve as a reference for physicians and scientists who focus on clinical nervous cell applications and studies related to iPSCs.


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Standards of induced pluripotent stem cells derived clinical-grade neural stem cells preparation and quality control (2021 China version)

Show Author's information Meng Cai1Fabin Han2Nanxiang Xiong3( )Yihao Wang4Shiqing Feng5Jiajing Wang4Xiang Li3Jun Wei1Changkai Sun6
iRegene Therapeutics Ltd., Wuhan 430000, Hubei, China
The Institute for Tissue Engineering & Regenerative Medicine, Liaocheng University / Liaocheng People’s Hospital, Liaocheng 252000, Shandong, China
Department of Neurosurgery of Zhongnan Hospital, Wuhan University, Wuhan 43071, Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, Hubei, China
Department of Orthopedics, Tianjin Medical University, Tianjin 300070, China
The Research and Educational Center for the Control Engineering of Translational Precision Medicine, School of Biomedical Engineering, and the Key Laboratory of Integrated Circuit and Biomedical Electronic System of Liaoning Province, Dalian University of Technology, Dalian 116024, Liaoning, China

Abstract

Induced pluripotent stem cells (iPSCs) have become the leading research object in the clinical application of restorative medicine. They are easily generated from diverse cell sources and functionally indistinguishable from embryonic stem cells without the accompanying ethical issues. To date, the use of iPSC-derived neural stem cells and their progeny in the treatment of neurodegenerative and injurious diseases has achieved good results, with great potential in cell drug development. However, because of some unique biological properties and differences from traditional drug production processes, cell drug research and development has many problems that can hinder clinical applications. Given this situation, the Chinese Association of Neurorestoratology (Preparatory) and China Committee of the International Association of Neurorestoratology have organized relevant professional experts to formulate the standard presented here. Overall, the aim was to promote the clinical application of neural stem cells (NSCs) and their further derived neural cells from iPSC sources and promote cell drugs’ production and development. This standard refers to the latest research results, quality evaluation criteria for traditional medicines, and the regulatory framework for cellular treatments. The standard considers general biological properties of cells, including cell morphology, cell cycle, karyotype, and cell viability. The specific biological properties of NSCs, such as cell surface markers and differentiation ability, general drug standards, such as aseptic testing, endotoxins, human virus detection, and cell-related drug standards, such as telomerase activity and tumorigenicity, are also considered. This standard will serve as a reference for physicians and scientists who focus on clinical nervous cell applications and studies related to iPSCs.

Keywords: preparation, standard, clinical-grade, quality control, induced pluripotent stem cells, neural stem cells

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Publication history
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Publication history

Received: 03 November 2020
Revised: 22 March 2021
Accepted: 28 March 2021
Published: 09 June 2021
Issue date: March 2021

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© The authors 2021

Acknowledgements

All the experts that contributed to this standard are gratefully acknowledged. Special thanks are given to Professor Xiaobing Zhang for many helpful suggestions.

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This article is published with open access at http://jnr.tsinghuajournals.com

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