Regulation and Evidence Limits

The article frames personal cells as belonging to the individual rather than as manufactured drugs, while acknowledging that heavier manipulation moves closer to drug regulation. The article is not a systematic review and provides evidence of varying strength across clinical experience, anecdotes, animal research, internal observations, and regulatory history. The article warns that many claims are based on anecdotes, internal data, or unpublished observations rather than fully described randomized trials. The article describes a legal dispute over whether isolating and returning a person's own cells constituted drug manufacturing. Gene editing and engineered cells are described as requiring proper regulatory pathways if manipulation exceeds minimal handling.