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Journal of Neurorestoratology 2022, 10(2): 100001 https://doi.org/10.1016/j.jnrt.2022.100001
Practice Guidelines | Open Access | Issue | Published: 10 May 2022

Preparation and quality control standard of clinical-grade neural progenitor/precursor cells-derived exosomes (2022 China version)

Show Author's Information Lukui Chena,1( ),  Guilong Zhangb,1,  Shiqing Fengc,d,  Mengzhou Xuee,  Jinquan Caif,  Lin Cheng,  Yubin Dengh,  Yunliang Wangi
Department of Neurosurgery, Neuroscience Center, Integrated Hospital of Traditional Chinese Medicine, Southern Medical University, Guangzhou 510310, Guangdong, China
Department of Neurosurgery, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou 510260, Guangdong, China
Department of Orthopaedics, Tianjin Medical University General Hospital, Tianjin 300052, China
Department of Orthopaedics, Shandong University Center for Orthopaedics, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan 250063, Shandong, China
Department of Cerebrovascular Diseases, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, Henan, China
Department of Neurosurgery, The Second Affiliated Hospital of Harbin Medical University, Harbin 150081, Heilongjiang, China
Department of Neurosurgery, Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine, Beijing 100700, China
Scientific Research Center, Bone and Nerve Repair Center, The Seventh Affiliated Hospital, Sun Yat-Sen University, Shenzhen 518107, Guangdong, China
Department of Neurology, The 960th Hospital of Joint Logistics Support Force of PLA, Zibo 552300, Shandong, China

1 These authors contributed equally to this work.

Keywords:
Exosomes, Preparation, Clinical-grade, Quality control, Neural progenitor/precursor cells
Cite this article:
Chen L, Zhang G, Feng S, et al. Preparation and quality control standard of clinical-grade neural progenitor/precursor cells-derived exosomes (2022 China version). Journal of Neurorestoratology, 2022, 10(2): 100001. https://doi.org/10.1016/j.jnrt.2022.100001
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Abstract Full text About this article

So far many people still believe that there is a lack of effective drugs or strategies to restore the dysfunction and/or the damaged structure of refractory neurological diseases. However, neurorestorative treatments are being tried to change the state. Transplanted neural progenitor/precursor cells (NPCs) as a novel therapy strategy played an important role in promoting neurological function restoration. Evidence demonstrated that the positive effects of grafted NPCs were mediated mainly by the releasing paracrine factors, especially exosomes, which were derived from NPCs. Exosomes are important paracrine molecules involved in cellular functions and cell-cell communications. This standard was set up by the Chinese Association of Neurorestoratology (CANR; Preparatory) and the China Committee of International Association of Neurorestoratology (IANR-China Committee) to provide rational guidance for technological transformation and clinical applications. In this standard, we highlighted the nature and features of NPC-derived exosomes, aimed to integrate the production, education, and research on the clinical-grade NPC-derived exosomes, promote the relevant standards and regulations established by the government and promote to make the world professional standards.


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About this article

Preparation and quality control standard of clinical-grade neural progenitor/precursor cells-derived exosomes (2022 China version)

Show Author's information Lukui Chena,1( ), Guilong Zhangb,1, Shiqing Fengc,d, Mengzhou Xuee, Jinquan Caif, Lin Cheng, Yubin Dengh, Yunliang Wangi
Department of Neurosurgery, Neuroscience Center, Integrated Hospital of Traditional Chinese Medicine, Southern Medical University, Guangzhou 510310, Guangdong, China
Department of Neurosurgery, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou 510260, Guangdong, China
Department of Orthopaedics, Tianjin Medical University General Hospital, Tianjin 300052, China
Department of Orthopaedics, Shandong University Center for Orthopaedics, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan 250063, Shandong, China
Department of Cerebrovascular Diseases, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, Henan, China
Department of Neurosurgery, The Second Affiliated Hospital of Harbin Medical University, Harbin 150081, Heilongjiang, China
Department of Neurosurgery, Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine, Beijing 100700, China
Scientific Research Center, Bone and Nerve Repair Center, The Seventh Affiliated Hospital, Sun Yat-Sen University, Shenzhen 518107, Guangdong, China
Department of Neurology, The 960th Hospital of Joint Logistics Support Force of PLA, Zibo 552300, Shandong, China

1 These authors contributed equally to this work.

Abstract

So far many people still believe that there is a lack of effective drugs or strategies to restore the dysfunction and/or the damaged structure of refractory neurological diseases. However, neurorestorative treatments are being tried to change the state. Transplanted neural progenitor/precursor cells (NPCs) as a novel therapy strategy played an important role in promoting neurological function restoration. Evidence demonstrated that the positive effects of grafted NPCs were mediated mainly by the releasing paracrine factors, especially exosomes, which were derived from NPCs. Exosomes are important paracrine molecules involved in cellular functions and cell-cell communications. This standard was set up by the Chinese Association of Neurorestoratology (CANR; Preparatory) and the China Committee of International Association of Neurorestoratology (IANR-China Committee) to provide rational guidance for technological transformation and clinical applications. In this standard, we highlighted the nature and features of NPC-derived exosomes, aimed to integrate the production, education, and research on the clinical-grade NPC-derived exosomes, promote the relevant standards and regulations established by the government and promote to make the world professional standards.

Keywords: Exosomes, Preparation, Clinical-grade, Quality control, Neural progenitor/precursor cells

References(20)

1.
CurtisEMartinJRGabelBA first-in-human, phase I study of neural stem cell transplantation for chronic spinal cord injuryCell Stem Cell2018226941950.e6

Curtis E, Martin JR, Gabel B, et al. A first-in-human, phase I study of neural stem cell transplantation for chronic spinal cord injury. Cell Stem Cell. 2018, 22(6): 941-950.e6.

10.1016/j.stem.2018.05.014
DOI Google Scholar
2.
KalladkaDSindenJPollockKHuman neural stem cells in patients with chronic ischaemic stroke (PISCES): a phase 1, first-in-man studyLancet201638810046787796

Kalladka D, Sinden J, Pollock K, et al. Human neural stem cells in patients with chronic ischaemic stroke (PISCES): a phase 1, first-in-man study. Lancet. 2016, 388(10046): 787-796.

10.1016/S0140-6736(16)30513-X
DOI Google Scholar
3.

Bond AM, Ming GL, Song HJ. Adult mammalian neural stem cells and neurogenesis: five decades later. Cell Stem Cell. 2015, 17(4): 385-395.
DOI Google Scholar
4.

Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020, 367(6478): eaau6977.
DOI Google Scholar
5.
O'BrienKBreyneKUghettoSRNA delivery by extracellular vesicles in mammalian cells and its applicationsNat Rev Mol Cell Biol2020211058560610.1038/s41580-020-0251-y

O'Brien K, Breyne K, Ughetto S, et al. RNA delivery by extracellular vesicles in mammalian cells and its applications. Nat Rev Mol Cell Biol. 2020, 21(10): 585-606.
DOI Google Scholar
6.
SahooSAdamiakMMathiyalaganPTherapeutic and diagnostic translation of extracellular vesicles in cardiovascular diseases: roadmap to the clinicCirculation2021143141426144910.1161/circulationaha.120.049254

Sahoo S, Adamiak M, Mathiyalagan P, et al. Therapeutic and diagnostic translation of extracellular vesicles in cardiovascular diseases: roadmap to the clinic. Circulation. 2021, 143(14): 1426-1449.
DOI Google Scholar
7.
ThéryCWitwerKWAikawaEMinimal information for studies of extracellular vesicles 2018 (MISEV2018): a position statement of the International Society for Extracellular Vesicles and update of the MISEV2014 guidelinesJ Extracell Vesicles201871153575010.1080/20013078.2018.1535750

Théry C, Witwer KW, Aikawa E, et al. Minimal information for studies of extracellular vesicles 2018 (MISEV2018): a position statement of the International Society for Extracellular Vesicles and update of the MISEV2014 guidelines. J Extracell Vesicles. 2018, 7(1): 1535750.
DOI Google Scholar
8.

Zhang ZG, Buller B, Chopp M. Exosomes - beyond stem cells for restorative therapy in stroke and neurological injury. Nat Rev Neurol. 2019, 15(4): 193-203.
DOI Google Scholar
9.
ShelleyBCGowingGSvendsenCNA cGMP-applicable expansion method for aggregates of human neural stem and progenitor cells derived from pluripotent stem cells or fetal brain tissueJ Vis Exp20148851219

Shelley BC, Gowing G, Svendsen CN. A cGMP-applicable expansion method for aggregates of human neural stem and progenitor cells derived from pluripotent stem cells or fetal brain tissue. J Vis Exp. 2014(88): 51219.

10.3791/51219
DOI Google Scholar
10.
WatsonDCYungBCBergamaschiCScalable, cGMP-compatible purification of extracellular vesicles carrying bioactive human heterodimeric IL-15/lactadherin complexesJ Extracell Vesicles201871144208810.1080/20013078.2018.1442088

Watson DC, Yung BC, Bergamaschi C, et al. Scalable, cGMP-compatible purification of extracellular vesicles carrying bioactive human heterodimeric IL-15/lactadherin complexes. J Extracell Vesicles. 2018, 7(1): 1442088.
DOI Google Scholar
11.
FengSQXiaoJHanFBNeurorestorative clinical application standards for the culture and quality control of neural progenitor/precursor cells (version 2017)J Neurorestoratol2018611511910.3390/rs10010115

Feng SQ, Xiao J, Han FB, et al. Neurorestorative clinical application standards for the culture and quality control of neural progenitor/precursor cells (version 2017). J Neurorestoratol. 2018, 6: 115-119.
DOI Google Scholar
12.
Martínez-GreeneJAHernández-OrtegaKQuiroz-BaezRQuantitative proteomic analysis of extracellular vesicle subgroups isolated by an optimized method combining polymer-based precipitation and size exclusion chromatographyJ Extracell Vesicles2021106e12087

Martínez-Greene JA, Hernández-Ortega K, Quiroz-Baez R, et al. Quantitative proteomic analysis of extracellular vesicle subgroups isolated by an optimized method combining polymer-based precipitation and size exclusion chromatography. J Extracell Vesicles. 2021, 10(6): e12087.

10.1002/jev2.12087
DOI Google Scholar
13.
OeyenEvan MolKBaggermanGUltrafiltration and size exclusion chromatography combined with asymmetrical-flow field-flow fractionation for the isolation and characterisation of extracellular vesicles from urineJ Extracell Vesicles201871149014310.1080/20013078.2018.1490143

Oeyen E, van Mol K, Baggerman G, et al. Ultrafiltration and size exclusion chromatography combined with asymmetrical-flow field-flow fractionation for the isolation and characterisation of extracellular vesicles from urine. J Extracell Vesicles. 2018, 7(1): 1490143.
DOI Google Scholar
14.

Herrmann IK, Wood MJA, Fuhrmann G. Extracellular vesicles as a next-generation drug delivery platform. Nat Nanotechnol. 2021, 16(7): 748-759.
DOI Google Scholar
15.
TrenkenschuhERichterMHeinrichEEnhancing the stabilization potential of lyophilization for extracellular vesiclesAdv Healthc Mater2021e2100538

Trenkenschuh E, Richter M, Heinrich E, et al. Enhancing the stabilization potential of lyophilization for extracellular vesicles. Adv Healthc Mater. 2021:e2100538.

10.1002/adhm.202100538
DOI Google Scholar
16.

Yuan FM, Li YM, Wang ZH. Preserving extracellular vesicles for biomedical applications: consideration of storage stability before and after isolation. Drug Deliv. 2021, 28(1): 1501-1509.
DOI Google Scholar
17.
RussellAESneiderAWitwerKWBiological membranes in EV biogenesis, stability, uptake, and cargo transfer: an ISEV position paper arising from the ISEV membranes and EVs workshopJ Extracell Vesicles201981168486210.1080/20013078.2019.1684862

Russell AE, Sneider A, Witwer KW, et al. Biological membranes in EV biogenesis, stability, uptake, and cargo transfer: an ISEV position paper arising from the ISEV membranes and EVs workshop. J Extracell Vesicles. 2019, 8(1): 1684862.
DOI Google Scholar
18.
ZhangGLZhuZHWangHExosomes derived from human neural stem cells stimulated by interferon gamma improve therapeutic ability in ischemic stroke modelJ Adv Res20202443544510.3390/met10040435

Zhang GL, Zhu ZH, Wang H, et al. Exosomes derived from human neural stem cells stimulated by interferon gamma improve therapeutic ability in ischemic stroke model. J Adv Res. 2020, 24: 435-445.
DOI Google Scholar
19.
ZhangGLChenLKGuoXYComparative analysis of microRNA expression profiles of exosomes derived from normal and hypoxic preconditioning human neural stem cells by next generation sequencingJ Biomed Nanotechnol201814610751089

Zhang GL, Chen LK, Guo XY, et al. Comparative analysis of microRNA expression profiles of exosomes derived from normal and hypoxic preconditioning human neural stem cells by next generation sequencing. J Biomed Nanotechnol. 2018, 14(6): 1075-1089.

10.1166/jbn.2018.2567
DOI Google Scholar
20.
StevanatoLThanabalasundaramLVysokovNInvestigation of content, stoichiometry and transfer of miRNA from human neural stem cell line derived exosomesPLoS One2016111e014635310.1371/journal.pone.0146353

Stevanato L, Thanabalasundaram L, Vysokov N, et al. Investigation of content, stoichiometry and transfer of miRNA from human neural stem cell line derived exosomes. PLoS One. 2016, 11(1): e0146353.
DOI Google Scholar
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Publication history

Received: 10 November 2021
Revised: 05 January 2022
Accepted: 24 January 2022
Published: 10 May 2022
Issue date: June 2022

Copyright

© 2022 The Authors. Published by Elsevier Ltd on behalf of Tsinghua University Press.

Acknowledgements

Acknowledgements

This work was supported by the National Natural Science Foundation of China (Grant Nos. 81671819 and 82171459) and the Natural Science Foundation of Guangdong Province (Grant Nos. 2019A1515012103 and 2021A1515010001).

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This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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