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Review
. 2020 Dec;53(12):e12926.
doi: 10.1111/cpr.12926. Epub 2020 Nov 4.

General requirements for stem cells

Jie Hao  1   2 , Aijin Ma  2   3   4 , Lei Wang  1   2 , Jiani Cao  1   2 , Si Chen  1   2 , Liu Wang  1   2 , Boqiang Fu  2   5 , Jiaxi Zhou  2 , Xuetao Pei  2 , Yu Zhang  2 , Peng Xiang  2 , Shijun Hu  2 , Qiyuan Li  2 , Yong Zhang  2 , Yingjie Xia  1   2 , Huanxin Zhu  1   2 , Glyn Stacey  1 , Qi Zhou  1   2 , Tongbiao Zhao  1   2
Affiliations
Review

General requirements for stem cells

Jie Hao et al. Cell Prolif. 2020 Dec.

Abstract

The standard 'General requirements for stem cells' is the first set of general guidelines for stem cell research and production in China, jointly drafted and agreed upon by experts from the Chinese Society for Stem Cell Research. This standard specifies the classification, ethical requirements, quality requirements, quality control requirements, detection control requirements and waste disposal requirements of stem cells, which is applicable to stem cell research and production. It was firstly released by the Chinese Society for Cell Biology on 1 August 2017 and was further revised on 30 April 2020. We hope that publication of these guidelines will promote institutional establishment, acceptance, and execution of proper protocols, and accelerate the international standardization of stem cells for clinical development and therapeutic applications.

Keywords: detection control; general requirements; quality control; stem cells; waste disposal.

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Conflict of interest statement

No potential conflicts of interest are disclosed.

References

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    1. State Food and Drug Administration . Good manufacture practice of medical products (Revised in 2010), Ministry of Health Order No. 79.
    1. National Health and Family Planning Commission of the People's Republic of China, China Food and Drug Administration . Guidelines for quality control of stem cell preparation and pre‐clinical research (trial) 2015.
    1. China Food and Drug Administration . Human cell therapy research and preparation quality control technology guidelines. 2003.
    1. National Health and Family Planning Commission of the People's Republic of China, China Food and Drug Administration . Management methods for clinical research of stem cells (trial). 2015.

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