Stem-Cell-Derived RPE Cells

Last medically reviewed: October 7, 2026

⚠ Important — educational information only, not medical advice

EyeCyte provides educational and scientific information and does not provide medical advice, diagnosis, or treatment. Emerging regenerative and biologic technologies discussed on this website may be experimental, investigational, unapproved, or supported only by preclinical evidence. Patients should discuss medical decisions with appropriately licensed healthcare professionals.
Not an FDA-approved treatment unless explicitly stated. Except where a page names an FDA-approved product, the stem-cell, MSC, exosome, extracellular-vesicle, Wharton’s jelly and other biologic approaches described here are not FDA-approved for any eye condition. Research findings — especially laboratory and animal studies — are not proof that anything works or is safe in people.
Research-Use-Only (RUO): Research-Use-Only (RUO) materials referenced on EyeCyte are for laboratory research by qualified professionals only. They are not drugs, biologics or devices approved for human use, are not intended for administration to people, and are not intended to diagnose, treat, cure, mitigate or prevent any disease.
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The retinal pigment epithelium (RPE) is a single layer of cells that supports the photoreceptors. RPE loss is central to macular degeneration, which is why RPE cells grown from pluripotent stem cells are among the most studied cell-replacement approaches in the eye.

Research is not treatment. The studies summarized below are investigational. They are presented for education only, do not show that any approach is safe or effective in patients, and are not a recommendation. Unless stated as FDA-approved, none of these approaches is approved for this condition. RUO materials are not for human use.

How RPE cells are studied

Researchers have delivered RPE cells as injected suspensions and as cell sheets or patches on a supporting scaffold.

Human research

Early-phase human studies of embryonic-stem-cell-derived RPE in AMD and Stargardt disease have been published, focusing on safety and feasibility in small numbers of participants.^{[1, 2, 3]}

Where the evidence stands

These studies do not establish that RPE transplantation improves vision. Larger controlled trials would be needed.

Regulatory status: to our knowledge as of our last review, no product in this category is FDA-approved to treat an eye disease. The FDA has warned the public about unapproved stem cell and exosome products.

Answers

Related conditions

Frequently Asked Questions

Is RPE transplantation a treatment for macular degeneration?

It is an investigational approach studied in early-phase trials, not an established treatment.

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References

Schwartz SD, et al. Human embryonic stem cell-derived retinal pigment epithelium in patients with age-related macular degeneration and Stargardt's macular dystrophy: follow-up of two open-label phase 1/2 studies. The Lancet, 2015. [Peer-reviewed study · citation details pending reviewer confirmation]
da Cruz L, et al. Phase 1 clinical study of an embryonic stem cell–derived retinal pigment epithelium patch in age-related macular degeneration. Nature Biotechnology, 2018. [Peer-reviewed study · citation details pending reviewer confirmation]
Kashani AH, et al. A bioengineered retinal pigment epithelial monolayer for advanced, dry age-related macular degeneration. Science Translational Medicine, 2018. [Peer-reviewed study · citation details pending reviewer confirmation]