ABSTRACT
This chapter traces the evolution of personalised therapeutic interventions, focusing on cell and gene-based therapies within regenerative medicine. Beginning with early tissue engineering and gene therapy in the 1980s, it examines how techniques such as autologous cell use, genetic targeting, and stem cell technologies have offered new avenues for tailoring treatments, while also confronting significant technical, regulatory, and commercial challenges. Case studies – including umbilical cord blood banking, induced pluripotent stem cells, organoids, and CAR-T therapies – illustrate the interplay between standardisation and customisation, as well as tensions between public and private delivery models. This chapter analyses how high costs, orphan drug provisions, and health technology assessments shape access, producing new forms of inclusion and exclusion. It highlights the often-overlooked ‘institutional readiness’ and ‘miscellaneous care’ work needed to integrate advanced therapies into healthcare systems, and contrasts solidaristic public-sector approaches with consumer-oriented, market-driven models. Looking ahead to emerging techniques such as gene editing, 3D bioprinting, and adaptive manufacturing, this chapter argues that personalisation in treatment is inherently socio-technical and political, requiring alignment between biological targeting, regulatory frameworks, and equitable healthcare delivery.
