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欧盟神经光遗传学的伦理与监管。

Ethics and regulation of neuronal optogenetics in the European Union.

机构信息

Law School, Faculty of Law, Economics and Business, Martin Luther University Halle-Wittenberg, Halle, Germany.

出版信息

Pflugers Arch. 2023 Dec;475(12):1505-1517. doi: 10.1007/s00424-023-02888-8. Epub 2023 Nov 24.


DOI:10.1007/s00424-023-02888-8
PMID:37996706
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10730653/
Abstract

Neuronal optogenetics is a technique to control the activity of neurons with light. This is achieved by artificial expression of light-sensitive ion channels in the target cells. By optogenetic methods, cells that are naturally light-insensitive can be made photosensitive and addressable by illumination and precisely controllable in time and space. So far, optogenetics has primarily been a basic research tool to better understand the brain. However, initial studies are already investigating the possibility of using optogenetics in humans for future therapeutic approaches for neuronal based diseases such as Parkinson's disease, epilepsy, or to promote stroke recovery. In addition, optogenetic methods have already been successfully applied to a human in an experimental setting. Neuronal optogenetics also raises ethical and legal issues, e.g., in relation to, animal experiments, and its application in humans. Additional ethical and legal questions may arise when optogenetic methods are investigated on cerebral organoids. Thus, for the successful translation of optogenetics from basic research to medical practice, the ethical and legal questions of this technology must also be answered, because open ethical and legal questions can hamper the translation. The paper provides an overview of the ethical and legal issues raised by neuronal optogenetics. In addition, considering the technical prerequisites for translation, the paper shows consistent approaches to address these open questions. The paper also aims to support the interdisciplinary dialogue between scientists and physicians on the one hand, and ethicists and lawyers on the other, to enable an interdisciplinary coordinated realization of neuronal optogenetics.

摘要

神经光遗传学是一种用光来控制神经元活动的技术。这是通过在目标细胞中人工表达对光敏感的离子通道来实现的。通过光遗传学方法,可以使自然对光不敏感的细胞变得对光敏感和可寻址,并且可以精确地在时间和空间上进行控制。到目前为止,光遗传学主要是一种基础研究工具,用于更好地了解大脑。然而,初步研究已经在探索将光遗传学用于人类的可能性,以治疗基于神经元的疾病,如帕金森病、癫痫或促进中风恢复。此外,光遗传学方法已经在实验环境中成功应用于人类。神经光遗传学也引发了伦理和法律问题,例如与动物实验及其在人类中的应用有关。当在大脑类器官上研究光遗传学方法时,可能会出现其他伦理和法律问题。因此,为了成功地将光遗传学从基础研究转化为医学实践,必须回答这项技术的伦理和法律问题,因为未解决的伦理和法律问题可能会阻碍转化。本文概述了神经光遗传学引发的伦理和法律问题。此外,考虑到转化的技术前提,本文展示了一致的方法来解决这些悬而未决的问题。本文还旨在支持科学家和医生与伦理学家和律师之间的跨学科对话,以便能够进行跨学科协调的神经光遗传学实现。

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本文引用的文献

[1]
Spatiotemporal, optogenetic control of gene expression in organoids.

Nat Methods. 2023-10

[2]
Donor perspectives on informed consent and use of biospecimens for brain organoid research.

Stem Cell Reports. 2023-7-11

[3]
A Tale of Two Chimeras: Applying the Six Principles to Human Brain Organoid Xenotransplantation.

Camb Q Healthc Ethics. 2023-2-27

[4]
Patent bibliometric analysis for global trend of organoid technologies in the past decade.

iScience. 2022-7-8

[5]
Implantable Micro-Light-Emitting Diode (µLED)-based optogenetic interfaces toward human applications.

Adv Drug Deliv Rev. 2022-8

[6]
[Not Available].

Medizinrecht. 2021

[7]
Taking Optogenetics into the Human Brain: Opportunities and Challenges in Clinical Trial Design.

Open Access J Clin Trials. 2020-8-25

[8]
Framing and legitimating EU legal regulation of human gene-editing technologies: key facets and functions of an imaginary.

J Law Biosci. 2021-8-16

[9]
The state of the art of biomedical applications of optogenetics.

Lasers Surg Med. 2022-2

[10]
The Application of Brain Organoid Technology in Stroke Research: Challenges and Prospects.

Front Cell Neurosci. 2021-6-21

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