A US-based company, Minicircle, is poised to launch an unapproved gene therapy aimed at extending human lifespan, despite the absence of rigorous clinical trials or approval from major regulatory bodies such as the US Food and Drug Administration (FDA). The injectable treatment, designed to encourage cells to produce more of the protein klotho, is expected to be offered to individuals willing to travel to clinics in countries including Honduras, Panama, and the Bahamas within the next six months.
Minicircle, headquartered in Austin, Texas, has developed the therapy based on the known anti-ageing properties of klotho. Research from the 1990s indicated that mice lacking this protein aged rapidly, while those genetically engineered to produce excess klotho lived up to 30 per cent longer. Injections of the protein have also shown improvements in memory in older monkeys. Klotho levels naturally decline in humans with age, leading to efforts to replenish them.
However, medical ethicists have voiced strong warnings regarding the company's decision to bypass established regulatory frameworks. Christopher Rudge from the University of Sydney, Australia, highlighted the dangers of applying a 'move fast and break things' approach to medicine, suggesting it could jeopardise patient safety. Concerns are amplified by the fact that many substances shown to extend lifespan in mice have not had the same effect in humans. Furthermore, a rare genetic condition leading to excess klotho in an infant was associated with weak bones and growth problems, suggesting that too much of the protein could be detrimental.
Minicircle's 'life-extension' gene therapy involves injecting small, circular DNA (minicircle DNA) into abdominal fat, which instructs fat cells to synthesise klotho. This klotho then circulates throughout the body. The company states that the introduced DNA remains outside the chromosomes and eventually breaks down, with effects estimated to last up to a year. While Minicircle has conducted a 'proof of concept' trial involving approximately 24 people, the results have not yet been published, though the company claims it is preparing clinical trial data for publication.
The company justifies its approach by citing the significant financial and time commitments required for FDA approval, estimating over $300,000 (approximately £236,000) and up to three years to gain approval for a clinical trial in the US. This has led them to partner with clinics in regions described as 'innovation-friendly', such as Próspera in Honduras, which allows drug developers to 'opt in to the regulations that most suit your business needs'. The founder and CEO, Mac Davis, has stated he received the therapy himself, reporting temporary dizziness and altered perceptions, along with perceived immune system improvements.