Issue Regulatory gaps and long-term safety uncertainty for anti-ageing therapies

Summary

Anti-ageing therapies face a regulatory system that does not yet recognise ageing as a disease, which structurally constrains the development and clinical testing of genuine rejuvenation treatments. There are no guidelines for designing trials that target ageing, leaving evaluation indicators, observation periods and end points undefined. Safety and efficacy standards for advanced biopharmaceuticals are also incomplete, so rules for cellular reprogramming and gene therapy still need to be put in order. Scientifically, the interactions among the twelve hallmarks of ageing and the diversity of ageing mechanisms across tissues and cells remain poorly understood. Reprogramming carries a risk of tumour formation linked to the properties of induced pluripotent stem cells, yet only short-term data exist where decades of follow-up would be needed.