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In an ambitious pursuit of radical human life extension, Unlimited Bio, a biotech company, is poised to launch an unusual clinical trial next month. A select group of 12 to 15 volunteers will undergo a series of injections delivering two experimental gene therapies, primarily targeting muscle enhancement and increased blood supply. The company, led by CEO Ivan Morgunov, harbors the long-term aspiration of achieving unprecedented human longevity. The volunteers, who will bear the full cost of their travel and treatment, will receive injections in their arm and leg muscles. One therapy aims to boost blood flow, while the other is designed to stimulate muscle growth, with the hope of improving strength, endurance, and recovery times. Looking beyond muscle enhancement, Unlimited Bio also has plans to explore similar therapies for hair loss and erectile dysfunction in the future.
However, the scientific community has voiced significant concerns regarding the trial’s design and scope. Holly Fernandez Lynch, a medical ethicist and lawyer at the University of Pennsylvania, points out the inherent limitations of a study involving multiple gene therapies administered to a small number of healthy individuals. She argues that such a trial is unlikely to yield conclusive results or offer meaningful insights into longevity. Despite these reservations, Unlimited Bio’s therapies are already gaining traction, partly due to their accessibility at clinics in Honduras and Mexico. The company has garnered publicity through endorsements from public figures. Khloe Kardashian notably tagged Unlimited Bio in a Facebook post about stem-cell treatments she and her sister Kim received at the Eterna clinic in Mexico. More recently, biohacking influencer Dave Asprey shared an Instagram Reel showcasing him receiving one of the treatments in Mexico, reaching an audience of 1.3 million. In the video, Adeel Khan, CEO of Eterna, touted the therapy’s potential for systemic vascular health improvements, with Asprey himself stating his intention to "upgrade my system for a little while to reduce my age and reduce my vascular risk."
Gene therapies, in essence, work by introducing new genetic material into the body’s cells, enabling them to produce specific proteins. While currently approved gene therapies are typically developed to address severe genetic diseases caused by absent or mutated proteins, a growing number of companies are now exploring their application in healthy individuals. Minicircle, another company operating in this space, has developed a gene therapy designed to increase the production of follistatin, a protein crucial for muscle growth. Minicircle claims its treatment can enhance muscle mass and contribute to a longer lifespan. Based in Próspera, a special economic zone in Honduras with its own regulatory framework, Minicircle’s follistatin therapy is accessible to anyone for a reported $25,000, and has attracted notable figures like longevity influencer Bryan Johnson.
Unlimited Bio’s CEO, Ivan Morgunov, a computer scientist with Russian-Israeli heritage, was reportedly inspired by Minicircle’s model. His personal ambition is "radical life extension," and he has publicly stated his belief that he could be part of "the last generation throughout human history to die from old age." Morgunov identifies drug regulation as the primary obstacle to advancing anti-aging and lifespan-extending therapies. Consequently, he established his biotech company within Próspera, a location he believes is essential for its existence. Vladimir Leshko, Unlimited Bio’s chief operating officer and a former electrical engineer and professional poker player who retrained in biomedical engineering, echoed this sentiment, stating, "A company like ours couldn’t exist outside of Próspera."
Within Próspera, Morgunov and his team are investigating two gene therapies. One is another follistatin therapy, aimed at increasing muscle mass. The second therapy targets the production of vascular endothelial growth factor (VEGF), a compound known for its role in promoting blood vessel growth. The combined effect, the company hopes, will lead to enhanced muscle development, improved muscle repair, and ultimately, extended lifespan. Importantly, neither of these treatments is designed to alter the recipient’s DNA, thus precluding any hereditary changes. Leshko characterizes the therapies as "preventive-slash-enhancing," suggesting potential benefits such as faster recovery from exercise, increased strength, and greater endurance for healthy individuals.
The clinical trial will involve 12 to 15 volunteers, with half receiving only the follistatin therapy and the other half receiving both VEGF and follistatin therapies. The treatments will be administered through a series of injections into the major muscles of the arms and legs. Morgunov expresses confidence in the safety of the VEGF therapy, noting its prior approval in Russia over a decade ago for treating lower-limb ischemia, a condition causing pain and ulcers in the legs and feet. He estimates, based on published data, that approximately 10,000 individuals in Russia have received the drug, though he acknowledges a lack of exhaustive verification.
However, other researchers remain unconvinced. Seppo Ylä-Herttuala, a professor of molecular medicine at the University of Eastern Finland with extensive experience in VEGF research, questions the number of people who have received VEGF gene therapy in Russia. He emphasizes that the safety of VEGF therapy is highly dependent on the dosage and administration site, citing instances where cardiac injections led to fluid buildup (edema) and potential blindness if VEGF reaches the eye. Leshko counters that the VEGF is intended to remain localized at the injection site and any systemic circulation would be transient.
Ylä-Herttuala also points to the lack of rigorous clinical trials for the Russian VEGF therapy, suggesting that while it might offer benefits to some patients, the supporting evidence is weak. He further asserts that VEGF’s function is limited to blood vessel growth and does not directly address aging, stating definitively, "VEGF is not a longevity drug." Leshko, however, cites a 2021 study in mice that indicated a potential link between aging and reduced VEGF activity, leading him to conclude, "We’re convinced it qualifies as a potential longevity drug."
Data regarding follistatin is even more limited. Minicircle, the company marketing a follistatin gene therapy, has not published comprehensive clinical trial data, and much of the current evidence comes from rodent studies, according to Ylä-Herttuala.
The delivery methods for these therapies also raise questions. Unlimited Bio’s VEGF therapy will be administered via a circular piece of genetic code known as a plasmid, which is generally considered safer and has a shorter lifespan in the body compared to adeno-associated virus (AAV) vectors. Unlimited Bio’s follistatin therapy, however, will use AAV vectors, which can persist in the body for months and potentially trigger adverse immune responses. Ylä-Herttuala notes that AAV therapies are generally considered less safe than plasmid therapies.
Fernandez Lynch questions the ethical implications of exposing healthy individuals to these potential risks, especially given that the technology still faces significant safety and effectiveness questions even for those with life-threatening conditions. She argues that for healthy individuals, the risks of harm are amplified, potentially having a more profound impact on their lives. Leshko, on the other hand, vehemently disagrees, highlighting the daily deaths from age-related causes and arguing that imposing "ethical barriers" around trials involving "aging humans" is itself unethical. Morgunov did not respond to requests for comment.
Despite these ethical debates, there is a clear demand from some individuals to explore these treatments. Biohacking influencer Dave Asprey, who has publicly declared his intention to "live to 180," referred to VEGF as a "longevity compound," and Eterna’s CEO, Adeel Khan, described it as "the ultimate upgrade." Neither Asprey nor Khan responded to requests for comment. Michael Gusmano, a professor of health policy at Lehigh University, expresses concern that such messaging could foster unrealistic expectations among trial participants, leading to "therapeutic misconception" when "celebrity online influencers" promote interventions with sparse scientific evidence. He emphasizes that the primary guaranteed outcome for volunteers is contributing to the collective knowledge about these interventions. Gusmano stated, "I would certainly not recommend that anyone I know enter into such a trial."
The muscle study is envisioned as a preliminary step. Unlimited Bio aims to further investigate the VEGF therapy for applications in treating baldness and erectile dysfunction. Leshko points to mouse studies linking elevated VEGF levels to increased hair follicle density and hopes to trial VEGF injections into the scalps of volunteers, a self-experimentation Morgunov, who is largely bald, has already begun.
A trial for erectile dysfunction is also being considered. Leshko finds the prospect of injecting gene therapy into the penis "exciting" and anticipates a protocol involving five to ten injections. However, Ylä-Herttuala remains skeptical, arguing that hair growth is primarily hormonal and injecting any substance into the penis carries a risk of damage, with potential for edema. He also notes the existence of existing treatments for hair loss and erectile dysfunction, which set a high bar for any new therapies to be demonstrably safer or more effective.
Despite these reservations, Ylä-Herttuala acknowledges that small trials can still offer valuable insights. He concedes that the therapies might indeed increase muscle mass, potentially benefiting healthy recipients. After reviewing Unlimited Bio’s website, which promotes "The Most Advanced Rejuvenation Solution," Ylä-Herttuala remarked, "They promise a lot. I hope it’s true."
