Co-evolutionary and systemic study on the evolution of emerging stem cell-based therapies

Newly emerging therapeutic technologies have the potential to reconfigure the understanding, diagnosis, and treatment of diseases, and, consequently, to impact human health. This study integrates co-evolutionary and system-oriented perspectives to investigate factors influencing the way emerging therapies evolve in their attempt to become established medical practices. We examined the case of the use of induced pluripotent stem (iPS) cell-based therapies for age-related macular degeneration (AMD) disease. Cell therapy evolution is explored by considering their constitutive components, namely disease, biomedical technologies, and clinical practices, and observing the changes experienced by their underlying knowledge structures. We adopted a mixed methods approach that simultaneously uses publication, patent, and clinical trial data. Our results highlight the significance of the diversity of technological possibilities, the role of subjective issues in the selection of directions of search, the complementary nature between established and emerging therapies, and the tight product-process interdependencies. This study contributes to an understanding of the difficulties encountered during the emergence of new cell therapies, and the ways in which such difficulties can be circumvented to establish effective and safe cell-based clinical practices.