The Progression of Regenerative Medicine and its Impact on Therapy Translation

Abstract

Despite regenerative medicine (RM) being one of the hottest topics in biotechnology for the past 3 decades, it is generally acknowledged that the field’s performance at the bedside has been somewhat disappointing. This may be linked to the novelty of these technologies and their disruptive nature, which has brought an increasing level of complexity to translation. Therefore, we look at how the historical development of the RM field has changed the translational strategy. Specifically, we explore how the pursuit of such novel regenerative therapies has changed the way experts aim to translate their ideas into clinical applications, and then identify areas that need to be corrected or reinforced in order for these therapies to eventually be incorporated into the standard‐of‐care. This is then linked to a discussion of the preclinical and postclinical challenges remaining today, which offer insights that can contribute to the future progression of RM.

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“…Preclinical research is the gateway to the more complicated and ever-challenging clinical or human research ( Huang et al, 2020 ). Concerning this, translational medicine is a discipline that provides the interconnectivity between preclinical and clinical research, the interpretation of preclinical outcomes, and its application into clinical studies ( Cohrs et al, 2015 ; Jacques and Suuronen, 2020 ). Preclinical research is important especially for drug discoveries and treatment efficiencies to ensure their safety and efficacy before being applied to humans ( Regenberg et al, 2009 ; Varga et al, 2010 ; Park and Schaer, 2019 ).…”

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“…The RM related technologies and methods include, but are not limited to, stem cell therapy, organ reconstruction in vitro, etc. (4). The applications of stem cell therapy in RM contain exogenous cell transplantation and endogenous cell activation (5).…”

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“…Although regenerative medicine has been seen as an attractive form of therapy for several decades, its overall success in clinical translation is poor (Jacques & Suuronen, 2020). According to allied market research, the market for regenerative medicine would be worth US$67.5 billion by 2020 (Allickson, 2017).…”