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

• Published in: Biomedicine & pharmacotherapy 2022-09, Vol.153, p.113431-113431, Article 113431
• Main Authors: Beheshtizadeh, Nima, Gharibshahian, Maliheh, Pazhouhnia, Zahra, Rostami, Mohammadreza, Zangi, Ali Rajabi, Maleki, Reza, Azar, Hanieh Kolahi, Zalouli, Vahideh, Rajavand, Hosnieh, Farzin, Ali, Lotfibakhshaiesh, Nasrin, Sefat, Farshid, Azami, Mahmoud, Webster, Thomas J., Rezaei, Nima
• Format: Article
• Language: English
• Subjects: Commercialization; Immunological considerations; Regenerative medicine; Regulatory concerns; Tissue engineering
• ISSN: 0753-3322; 1950-6007
• DOI: 10.1016/j.biopha.2022.113431

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. [Display omitted] •All efforts in regenerative medicine must proceed through in silico, in vitro, in vivo, and clinical trials before they can move from the bench to the bedside.•Due to extensive regulations, principles, and financial requirements, a few regenerative medicine products have been commercialized.•Various monitoring centers promote the evaluation and commercialization of these products under design control procedures.•Clinical trials based on GCP and GMP regulations should be followed to design, implement, and report on human trials.•This comprehensive review includes the development, processes, regulatory concerns, and immunological considerations of regenerate medicine.