First Human Test of Cellular Rejuvenation Method to Begin Shortly

Harvard's David Sinclair co-founded Life Biosciences to bring age-reversing cellular reprogramming from mice to humans — and the first FDA-approved trial is nearly here.

First Human Test of Cellular Rejuvenation Method to Begin Shortly
Harvard University researcher David Sinclair 

Life Biosciences has received FDA approval to begin the first human trial of cellular reprogramming technology designed to reverse aging-related damage.

The Boston startup, cofounded by Harvard professor David Sinclair, will test treatment ER-100 on approximately 12 glaucoma patients. The therapy uses viruses to deliver three reprogramming genes—known as OSK—into one eye of each participant. The genes work by resetting epigenetic controls in cells, attempting to restore them to a younger state.

To prevent excessive reprogramming that could cause cancer, the genes activate only when patients take low doses of the antibiotic doxycycline. Initial treatment will run for approximately two months while effects are monitored. The approach stems from Nobel Prize-winning research showing that specific genes can convert cells into stem cells similar to those in early embryos. Scientists adapted this into "partial reprogramming"—limited exposure to these genes intended to rejuvenate cells without erasing their specialized functions. Sinclair reported in 2020 that partial reprogramming restored vision in mice after optic nerve damage, with evidence suggesting nerve regrowth.

The study appeared in Nature under the headline "Turning Back Time." The technology has attracted significant Silicon Valley investment, with hundreds of millions flowing to companies including Altos Labs, New Limit, and Retro Biosciences. However, these competitors remain years from human trials as they research optimal gene combinations to achieve age reversal without adverse effects.

Life Biosciences, formed in 2017, initially launched multiple subsidiaries targeting different aging aspects. After limited progress, the company hired CEO Jerry McLaughlin in 2021 and refocused on advancing Sinclair's mouse vision results toward human testing. The antibiotic-based switching mechanism, while standard in animal research, has not been tested in humans. Since the switch uses gene components from E. coli and the herpes virus, scientists note potential immune reactions. The OSK gene combination can activate hundreds of other genes and may revert cells to primitive stem-cell states under certain conditions. Glaucoma occurs when high pressure inside the eye damages the optic nerve. The trial represents a proof of concept for cellular reprogramming rather than immediate widespread rejuvenation therapy.

Read more at MIT Technology Review.

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