AGE/DOSE
Aging & Longevity

Biohackers Convene in Honduras for Unregulated Gene Therapy Trials Without FDA Oversight

Under purported “innovation-friendly” regulation in Próspera, Honduras, the biohacking company Minicircle is conducting trials testing whether their gene therapy technique bolsters muscle building and longevity.

By Bennett M. Sherman

Key Points:

  • Minicircle has developed a Honduran city where they can test a gene therapy for muscle enhancement and longevity promotion without Food and Drug Administration (FDA) oversight.
  • Minicircle’s gene therapy enrollment fee and other transactions are based strictly on cryptocurrency.
  • The biohacking company’s donors include big names like OpenAI’s Sam Altman and PayPal co-founder Peter Thiel, and its clients include the likes of anti-aging guru Bryan Johnson.

The biotech startup Minicircle is conducting human trials for a particular gene therapy targeting muscle building and longevity, among other medical conditions, in Próspera, Honduras. The reason for conducting its trials in Honduras pertains to lax regulations due to the country’s controversial legislation that has allowed international businesses to establish micronations there.

In this radical political experiment, private companies can take on the role of the state on their land. The partnership between the Honduran government and companies like Minicircle is meant to make Honduras a medical innovation hotbed and a future hub for medical tourism — where people travel to foreign countries for therapeutic treatments and procedures.

In Próspera, Minicircle aims to fuse elements of more traditional drug testing paths with the ethos of biohackers — medical mavericks who try self-experimentation techniques like DIY gene therapies in attempts to enhance their physiology. By avoiding FDA oversight, Minicircle intends to make state-of-the-art gene therapies more affordable to consumers. Adding to Minicircle’s enigma, they only use Bitcoin as legal tender. Unraveling the shrouds of mystery hovering over this biohacking company’s endeavor in Honduras as well as its specific technique to bolster longevity may provide a better perspective on their venture.

Testing Minicircle’s Gene Therapy Without FDA Approval

“I think the potential of the Minicircle technology is radically transformative and beneficial for everyone on Earth,” said Minicircle’s founder and CEO Mac Davis in a podcast interview, referencing the company’s technique to deliver gene therapy into people’s cells. “The keys to immortality: we’ve already discovered some of them. Our choice is just whether … to try it out and not be hampered by fear and regulation.”

Adding to the unorthodox nature of Minicircle’s venture in Honduras, the company uses injections of circular genetic constructs — “minicircles” — to deliver genetic material into cells. Hence, their name — Minicircle. However, human studies using this technique have failed to deliver DNA to the cell’s nucleus, where DNA resides, in a way that is safe and reliable, according to one of its creators, Mark Kay, a Stanford University professor of genetics.

Although the method has gained some success in vaccines, Kay does not understand how Minicircle could succeed where others have failed.

“Where’s the novelty in any of their technology?” he asks in MIT Technology Review. “How is it different?”

Minicircle’s gene therapy technique diverges from traditional gene therapy techniques, which utilize viral vectors — harmless viruses used to smuggle genetic information into the cell’s nucleus. However, Minicircle’s non-viral vector approach is far simpler and cheaper to produce, a possible reason for their adoption of this technique.

Using a Questionable Gene Therapy Technique to Bolster Muscle Building and Longevity

With their gene therapy method that may or may not actually work, Minicircle is implementing follistatin gene therapy to a clientele that includes aging guru and guinea pig Bryan Johnson. Follistatin is a protein that suppresses a muscle growth-inhibiting protein called myostatin. By boosting follistatin production and lowering myostatin, muscle cells can theoretically proliferate and expand without the usual biological checkpoints. As a result, animals with mutations in the gene coding for myostatin are muscle bound with cartoonishly bulging physiques. In this regard, follistatin gene therapy that inhibits myostatin may offer a quick means to boost muscle-building potential.

All the same, researchers have already tried manipulating this pathway to treat neuromuscular disorders involving weak or underdeveloped muscles.

“So far, nothing has proven to work in human clinical trials like it does in animal models,” says Scott Harper, a researcher at the Center for Gene Therapy at the Nationwide Children’s Hospital in Ohio.

With uncertain findings from trials testing increasing follistatin, Minicircle has potentially veered into quackery, aiming to use its gene therapy to enhance muscle building, overall well-being, and longevity. In this regard, Minicircle advertisements for follistatin gene therapy trials pitch it as a kind of age-reversing and muscle-bolstering elixir, something that may lack support from existing evidence.

According to the Minicircle CEO, though, “The follistatin gene therapy increases muscle mass in animals. It doubles bone density and halves body fat, the cardiovascular system is rapidly improved, the animals live longer, and they’re healthier,”

In reference to his company’s clinical trials, he says, “We’ve seen some very interesting effects.”

In response to Minicircle’s claims that follistatin gene therapy reduces chronic inflammation and body fat, enhances DNA repair, and promotes age reversal, Robert Kotin, a gene therapy expert at the University of Massachusetts Medical School skeptically says, “If I wanted to make a fountain-of-youth drug, I don’t think it would be follistatin.”

Prominent Figures Donating to Minicircle

Some big-name venture capitalists have donated to Minicircle’s gene therapy endeavors, including OpenAI’s Sam Altman, PayPal co-founder Peter Thiel, and AngelList CEO Naval Ravikant. Along those lines, Altman has reportedly invested some $250,000 in Minicircle, while the company appears to have raised another $150,000 from Thiel and Ravikant.

One prominent scientist, though, sees potential benefits to the growth of the biohacking sector: George Church, a professor of genetics at Harvard Medical School. As such, he says that he welcomes the evolution of biohacking experimentation into full-blown clinical trials.

Church is not familiar with Minicircle’s endeavors but says regarding the general premise, “As long as nothing goes wrong, it could herald a revolution in cost reduction.”

Worries Related to Medical Tourism

Some researchers familiar with Minicircle, including Stanford genetics professor Mark Kay, worry that desperate people who suffer from medical conditions that Minicircle studies may sign up for trials despite the use of unproven methods.

“I’ve had patients come to me because they hear about a treatment in some other country, and they’re spending all their life savings to get the treatment,” says Kay. “And it’s all bogus.”

Source

This biohacking company is using a crypto city to test controversial gene therapies. MIT Technology Review https://www.technologyreview.com/2023/02/13/1068330/minicircle-prospera-honduras-biohacking-follistatin-gene-therapy/.

References

Bryan Johnson is ‘human guinea pig’ in $25K-per-shot experiment. https://nypost.com/2023/12/21/business/bryan-johnson-is-human-guinea-pig-in-25k-per-shot-experiment/.

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