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Review | Open Access

Rethinking on ethics and regulations in cell therapy as part of neurorestoratology

Alok Sharma1,2( )Ziad M Al Zoubi3
Department of Neurosurgery, Lokmanya Tilak Municipal General (LTMG) Hospital and LTM Medical College, Mumbai, India
NeuroGen Brain and Spine Institute, Mumbai, India
Jordan Orthopedic and Spinal Centre, Amman, Jordan
Show Author Information

Abstract

Ethics, regulations, and evidence-based practices form the foundation of modern medicine. However, in recent years, and particularly in reference to cellular therapy, they have become obstacles to the growth and development of this new form of treatment. Based on four important documents, it is proposed that regulatory bodies and medical associations recommend an alternate way of looking at regulations for cell therapy, so as to ensure that only safe and effective treatments are offered to patients, and that greater availability of these new treatment options is also encouraged. The four documents on which these recommendations are based are: 1) World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects; 2) The International Society for Cellular Therapy “White paper” published in 2010; 3) The Beijing Declaration of the International Association of Neurorestoratology; and 4) New legislation passed in Japan in 2014 on regenerative medicine. These recommendations are: greater permissiveness for the use of cell therapy in incurable conditions, identify legitimate cell therapy services, promote medical innovation, respect the rights of patients to choose treatments, recognize the valid compassionate use of unapproved therapies, recognize the significance of small functional gains, give importance to practice-based evidence and existing published literature, have differing regulations for the different types of cell therapies, and adapt the new Japanese legislation for regenerative medicine.

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Journal of Neurorestoratology
Pages 1-14
Cite this article:
Sharma A, Al Zoubi ZM. Rethinking on ethics and regulations in cell therapy as part of neurorestoratology. Journal of Neurorestoratology, 2016, 4(1): 1-14. https://doi.org/10.2147/JN.S74135

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Published: 11 January 2016
© 2016 The Author(s).

© 2016 Sharma and Al Zoubi. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution - Non Commercial (unported, v3.0) License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php

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