The Art of Stem Cell-Based Therapy

Potency assays represent crucial experiments at the hub of the comprehensive complexity surrounding cell therapy. Moreover, numerous factors beyond biological and scientific considerations are involved in achieving successful potency assays that fulfil regulatory authority approval for a new advanced therapy medicinal product. Though this can mean a frustratingly long period of discovery and development, progress in cell therapy is nowadays proceeding remarkably quickly, assisted by the potency assay rigorously placing emphasis on the need to critically analyse the key factor/s responsible for the therapeutic mechanism of action. History has shown that it can take many decades for there to be an improved understanding of a mechanism of action. Yet the chasing of precise targets has revolutionised medicine, with no clearer example than approaches to viral pandemics. The centuries involved in the eradication of smallpox have paved the way for an unprecedented pace of vaccine development for the Covid-19 pandemic. Such extraordinary accomplishments foster encouragement that similarly for stem cell-based therapy, our scientific knowledge will continue to improve apace. This chapter focuses on the art of experimentation and discovery, introducing potency assay requisites and numerous factors that can influence potency assay outcomes. A comprehensive understanding of potency assays and their development can hasten the provision of new cell therapies to help resolve burdensome diseases of unmet medical need.