The start of FDA-approved clinical trials in cellular reprogramming marks a milestone that confronts expectations, risks, and ethical dilemmas surrounding aging and its implications for contemporary society.
The initiation of the first human trials using cellular reprogramming technology to reverse aging marks a turning point in global biomedical research.
The U.S. Food and Drug Administration (FDA) has authorized the start-up Life Biosciences, co-founded by Harvard biologist David Sinclair, to evaluate an experimental treatment known as ER-100 in patients with glaucoma.
According to MIT Technology Review, this trial aims to determine whether introducing reprogramming genes into the eye can restore cellular functions and treat age-related diseases, such as vision loss.
Sinclair stated on the X platform that the clinical trials would begin soon and emphasized: “Aging has a relatively simple explanation and, apparently, it is reversible. Clinical trials are starting soon,” a statement reported by MIT Technology Review.
During an exchange with Elon Musk, who at the Davos Forum defined aging as “a very solvable problem,” Sinclair confirmed that he was referring to the ER-100 treatment.
The experimental strategy involves introducing the so-called Yamanaka factors—reprogramming genes—into the eyes of people with glaucoma, a disease characterized by elevated intraocular pressure and progressive damage to the optic nerve.
The first phase will include a dozen volunteers, who will receive an injection of a virus carrying three reprogramming genes into one of their eyes. The genetic control will only be activated when the person consumes low doses of doxycycline for two months under initial observation.
Life Biosciences Chief Operating Officer Michael Ringel described the start of the clinical trial as “a tremendous event for us as an industry (...) it will be the first time in human history, after millennia of searching, that we will be testing something that rejuvenates.” This technology has attracted the interest of Silicon Valley firms such as Altos Labs, New Limit, and Retro Biosciences, which are also investing millions of dollars in the development of cellular rejuvenation therapies, according to MIT Technology Review.
The biotechnological basis of the study stems from the Nobel Prize-winning discovery made two decades ago: the introduction of certain genes can induce a specialized cell to revert to a stem cell state. These so-called Yamanaka factors act as a "factory reset" for cells.
However, complete reprogramming can induce tumor formation in laboratory animals, so current research is focused on "partial" or "transient" reprogramming, limited in time or in the number of genes used, to avoid the loss of cellular identity and reduce the risk of cancer.
In 2020, Sinclair published in Nature that partial reprogramming restored vision in mice with optic nerve damage and allowed for some regeneration of nerve fibers. The scientific community remains reserved about the magnitude and validity of these results as a genuine reversal of aging, MIT Technology Review reported.
Investor Karl Pfleger, of Shift Bioscience, compared reprogramming to "the artificial intelligence of the biological world" and confirmed that Life Biosciences is seeking new rounds of funding to advance its trials.
The debate about the possibilities of longevity and the reversal of aging intensified after a dialogue between Elon Musk and Larry Fink.
Musk noted: "I've never seen someone with an old left arm and a young right arm (...) there must be some kind of synchronizing clock in the 35 trillion cells of the human body."
Musk considered it likely that "ways to extend life and even reverse aging" will be achieved, although he also warned about the social risks of an indefinitely prolonged lifespan.
The popularity of Sinclair and his anti-aging proposals has been the subject of controversy. On previous occasions, Sinclair promoted the virtues of sirtuins and resveratrol, present in red wine, although some critics have questioned the robustness of his results. A 2024 report by The Wall Street Journal described him as an "anti-aging guru" and raised questions about the concrete achievements of his companies.
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