The First Human Trial of a Cellular Rejuvenation Therapy Set to Begin Soon
In a groundbreaking step towards the possibility of reversing aging, Life Biosciences, a Boston-based startup co-founded by Harvard researcher David Sinclair, has received FDA approval to initiate the first human trial of a novel rejuvenation treatment. The company plans to test a cutting-edge cellular reprogramming therapy aimed at treating glaucoma, an eye condition that leads to vision loss.
A Cutting-Edge Approach to Age Reversal
The experimental therapy, code-named ER-100, involves introducing genes into patients’ eye cells to ‘reset’ them to a more youthful state. This method, known as cellular reprogramming, attempts to restore the cells’ epigenetic controls — the gene switches that determine cell behavior — effectively rejuvenating them without altering their original identity or function.
This approach builds on the Nobel Prize-winning discovery of Yamanaka factors, a set of genes capable of turning mature cells back into stem cells. While full reprogramming can erase cell identity and lead to cancer, Life Biosciences employs a partial or transient reprogramming technique aimed at safely reversing age-related decline without causing harmful side effects.
David Sinclair’s 2020 research demonstrated that partial reprogramming restored vision in mice with damaged optic nerves, sparking interest in possible human applications.
How the Trial Will Work
The upcoming clinical trial will enroll approximately a dozen glaucoma patients. The treatment involves injecting viruses carrying three reprogramming genes — collectively called OSK — into one eye per patient. The expression of these genes will be controlled by a genetic “switch” activated only when patients take the antibiotic doxycycline, allowing precise regulation to minimize risks.
Patients are expected to take doxycycline for about two months, during which the therapy’s effects and safety will be closely monitored. The eye was chosen as a test site due to its accessibility and the potential for contained side effects.
A Promising Yet Cautious Step
Life Biosciences’ Chief Operating Officer Michael Ringel emphasized the historic nature of this trial, calling it “incredibly big” for the biotech industry. The study aims to demonstrate that cellular reprogramming can safely deliver rejuvenative benefits in humans and serve as a proof of concept to guide future therapies.
Despite excitement, experts urge caution. Cellular reprogramming is complex and not without risks. Some animal studies have shown tumor formation from similar gene therapies. Additionally, the antibiotic-based genetic switch used has not been tested in humans before and could trigger immune reactions.
Other biotech firms, including Silicon Valley-backed startups like Altos Labs and New Limit, are also exploring reprogramming but remain years away from human trials as they search for safer gene combinations.
The Bigger Picture on Aging Research
David Sinclair, a prominent voice in longevity science, suggests that the loss of epigenetic information is the fundamental cause of aging, a process reversible through reprogramming. Elon Musk recently expressed optimism about aging’s reversibility, a view Sinclair echoed in social media conversations.
While Sinclair has promoted other longevity strategies over the years — including molecules like resveratrol — he acknowledges the partial reprogramming approach as one of the most promising.
However, some critics question whether current evidence fully supports these claims, and note that turning fundamental science into safe, effective therapies will take time.
Looking Ahead
Life Biosciences, established in 2017, refocused its efforts on Sinclair’s vision restoration research and the push toward clinical trials after a strategic overhaul in 2021. For now, the primary goal is to assess the therapy’s safety and efficacy in treating eye disease, with broader applications including brain rejuvenation and whole-body age reversal remaining speculative.
If successful, this trial could pave the way for future treatments targeting age-related diseases and possibly, in the long term, broader aspects of human aging. However, experts caution that a ready-to-use anti-aging pill is not imminent.
The trial marks the first serious human test of a technology that could redefine medicine and our understanding of aging, signaling an exciting yet cautious milestone on the path to potential rejuvenation therapies.
By Antonio Regalado, MIT Technology Review
January 27, 2026
