Unapproved klotho gene therapy for longevity to be sold overseas to bypass FDA regulations
By
Alice Klein
Summary
A US-based company called Minicircle is planning to sell an unapproved gene therapy designed to boost longevity by increasing production of the anti-ageing protein klotho. The therapy will be offered at overseas clinics to bypass FDA regulations, as it has not undergone rigorous clinical trials or received approval from major regulatory bodies. This raises significant ethical and safety concerns about offering unproven medical treatments to consumers.
Source
Key quotes
· 3 pulledThe gene therapy, developed by Minicircle – a company headquartered in Austin, Texas – is designed to make cells produce more of an anti-ageing protein called klotho.
To get around the extensive clinical testing required by the FDA to approve a therapeutic product in the US, Minicir
This is despite the fact that it hasn't been tested in rigorous clinical trials and doesn't have approval from the US Food and Drug Administration (FDA) or other major regulators.
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