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Commercialization and regulation of regenerative medicine products: Promises, advances and challenges.

Nima Beheshtizadeh, Maliheh Gharibshahian, Zahra Pazhouhnia, Mohammadreza Rostami, Ali Rajabi Zangi, Reza Maleki, Hanieh Kolahi Azar, Vahideh Zalouli, Hosnieh Rajavand, Ali Farzin, Nasrin Lotfibakhshaiesh, Farshid Sefat, Mahmoud Azami, Thomas J Webster, Nima Rezaei

Journal: Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie 2022;153():113431

PMID: 36076549

Free Full Text on Elsevier Science View on PubMed

Abstract

The ultimate goal of regenerative medicine is to repair, regenerate, or reconstruct functional loss in failed tissues and/or organs. Although regenerative medicine is a relatively new field, multiple diverse research groups are helping regenerative medicine reach its objectives. All endeavors in this field go through in silico, in vitro, in vivo, and clinical trials which are prerequisites to translating such approaches from the bench to the bedside. However, despite such promise, there are only a few regenerative medicine approaches that have actually entered commercialization due to extensive demands for the inclusion of multiple rules, principles, and finances, to reach the market. This review covers the commercialization of regenerative medicine, including its progress (or lack thereof), processes, regulatory concerns, and immunological considerations to name just a few key areas. Also, commercially available engineered tissues, including allografts, synthetic substitutes, and 3D bioprinting inks, along with commercially available cell and gene therapeutic products, are reviewed. Clinical applications and future perspectives are stated with a clear road map for improving the regenerative medicine field.

Copyright © 2022 The Authors. Published by Elsevier Masson SAS.. All rights reserved.

Address: Department of Tissue Engineering, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran; Regenerative Medicine Group (REMED), Universal Scientific Education and Research Network (USERN), Tehran, Iran. Electronic address: [email protected].; Department of Tissue Engineering, School of Medicine, Shahroud University of Medical Sciences, Shahroud, Iran; Regenerative Medicine Group (REMED), Universal Scientific Education and Research Network (USERN), Tehran, Iran.; Department of Tissue Engineering, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran; Regenerative Medicine Group (REMED), Universal Scientific Education and Research Network (USERN), Tehran, Iran.; Division of Food Safety and Hygiene, Department of Environmental Health Engineering, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran; Food Science and Nutrition Group (FSAN), Universal Scientific Education and Research Network (USERN), Tehran, Iran.; Department of Pharmaceutics, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.; Computational Biology and Chemistry Group (CBCG), Universal Scientific Education and Research Network (USERN), Tehran, Iran.; Department of Pathology, Tabriz University of Medical Sciences, Tabriz, Iran.; Regenerative Medicine Group (REMED), Universal Scientific Education and Research Network (USERN), Tehran, Iran.; Department of Applied Cell Sciences, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran; Regenerative Medicine Group (REMED), Universal Scientific Education and Research Network (USERN), Tehran, Iran.; Department of Biomedical and Electronics Engineering, School of Engineering, University of Bradford, Bradford, UK; School of Engineering, Interdisciplinary Research Center in Polymer Science & Technology (Polymer IRC), University of Bradford, Bradford, UK.; Department of Tissue Engineering, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran; Regenerative Medicine Group (REMED), Universal Scientific Education and Research Network (USERN), Tehran, Iran. Electronic address: [email protected].; School of Biomedical Engineering and Health Sciences, Hebei University, Tijian, China; UFPI - Universidade Federal do Piauí, Brazil; Saveetha School of Engineering, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai, Tamil Nadu, India.; Department of Immunology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran; Research Center for Immunodeficiencies, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran; Network of Immunity in Infection, Malignancy and Autoimmunity (NIIMA), Universal Scientific Education and Research Network (USERN), Tehran, Iran. Electronic address: [email protected].
DOI: 10.1016/j.biopha.2022.113431

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MeSH Terms: Bioprinting, Regenerative Medicine, Tissue Engineering
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