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Diabetic Retinopathy & Diabetic Macular Edema and Regenerative Medicine Research

Last medically reviewed: October 7, 2026

What is diabetic retinopathy & diabetic macular edema?

Diabetic retinopathy is damage to the retina's blood vessels caused by diabetes. Diabetic macular edema (DME) is swelling of the macula from leaking vessels and is a common cause of vision loss in people with diabetes.

What causes diabetic retinopathy & diabetic macular edema?

Long-term high blood sugar damages small blood vessels; researchers study vascular leakage, inflammation, abnormal vessel growth and neural damage.

What structures or cells are affected?

Retinal capillaries and blood-retinal barrier, the macula, and retinal neurons.

How is diabetic retinopathy & diabetic macular edema currently treated or managed?

● Established / Approved
  • Control of blood sugar, blood pressure and cholesterol with a physician.
  • Regular dilated eye exams.
  • For DME, anti-VEGF injections and, in some cases, corticosteroid implants or laser.
  • Laser and surgery (vitrectomy) for advanced disease.

Are these approaches FDA approved for diabetic retinopathy & diabetic macular edema?

● Established / Approved Anti-VEGF medicines and other established treatments are approved for diabetic macular edema and diabetic retinopathy.[1]

No cell, exosome or Wharton’s jelly product is FDA-approved for diabetic retinopathy, to our knowledge as of our last review.[2]

Why are researchers studying regenerative approaches?

Researchers are interested in whether cell-derived signals could reduce inflammation or support damaged retinal vessels and neurons.

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.

Stem Cell Research and Diabetic Retinopathy & Diabetic Macular Edema

We have not identified research in this category for diabetic retinopathy & diabetic macular edema that meets our standards for inclusion.

MSC Research and Diabetic Retinopathy & Diabetic Macular Edema

  • ● Preclinical Animal EvidenceMesenchymal Stromal/Stem Cells (MSCs)

    Animal studies have explored MSCs in models of diabetic retinopathy. Animal findings have not established any benefit in people.

    EVIDENCE VERIFICATION REQUIRED. Specific studies have not yet been verified by our reviewers. Search the literature: PubMed search: mesenchymal stem cells diabetic retinopathy animal model

Extracellular Vesicle / Exosome Research and Diabetic Retinopathy & Diabetic Macular Edema

  • ● Preclinical Animal EvidenceExtracellular Vesicles

    Preclinical research has examined extracellular vesicles in diabetic retinopathy models. This is early-stage research.

    EVIDENCE VERIFICATION REQUIRED. Specific studies have not yet been verified by our reviewers. Search the literature: PubMed search: extracellular vesicles diabetic retinopathy

Other Cell-Based Research

We have not identified research in this category for diabetic retinopathy & diabetic macular edema that meets our standards for inclusion.

What Has Been Demonstrated in Laboratory Research?

We have not identified research in this category for diabetic retinopathy & diabetic macular edema that meets our standards for inclusion.

What Has Been Demonstrated in Animal Research?

  • ● Preclinical Animal EvidenceMesenchymal Stromal/Stem Cells (MSCs)

    Animal studies have explored MSCs in models of diabetic retinopathy. Animal findings have not established any benefit in people.

    EVIDENCE VERIFICATION REQUIRED. Specific studies have not yet been verified by our reviewers. Search the literature: PubMed search: mesenchymal stem cells diabetic retinopathy animal model
  • ● Preclinical Animal EvidenceExtracellular Vesicles

    Preclinical research has examined extracellular vesicles in diabetic retinopathy models. This is early-stage research.

    EVIDENCE VERIFICATION REQUIRED. Specific studies have not yet been verified by our reviewers. Search the literature: PubMed search: extracellular vesicles diabetic retinopathy

What Human Research Exists?

We have not identified research in this category for diabetic retinopathy & diabetic macular edema that meets our standards for inclusion.

Are Clinical Trials Underway?

Trial status changes often. Search the official U.S. registry directly: Diabetic Retinopathy + stem cell, Diabetic Retinopathy + exosome. A registered trial is not an endorsement, and registration does not mean a treatment works.

What Has NOT Yet Been Proven

● Insufficient Evidence
  • That any cell or vesicle approach slows or reverses diabetic retinopathy in people.

Potential Biological Mechanisms Researchers Are Investigating

● Mechanistic / Theoretical
AngiogenesisOcular InflammationOxidative Stress

Risks and Scientific Unknowns

  • Unapproved cell and biologic procedures offered outside clinical trials have been associated with serious harm, including permanent vision loss.
  • Products sold as "stem cells" or "exosomes" vary widely in what they actually contain; composition, purity and potency are often not independently verified.
  • Results in cells and animals frequently do not carry over to people; many approaches that look promising in the laboratory never reach approval.

Questions to Ask a Qualified Eye Doctor

  • What type and stage of this condition do I have, and how is it likely to progress?
  • Which treatments are established for my situation, and what are their benefits and risks?
  • Are there clinical trials I might qualify for, and how would I verify a trial is legitimate?
  • If I have seen a clinic offering stem cell or exosome procedures for my eyes, what questions should I ask?

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Related research questions

Related conditions: Age-Related Macular Degeneration · Glaucoma

Frequently Asked Questions

Are exosomes being studied for diabetic retinopathy?

In the laboratory and in animal models. There is no established human evidence, and no exosome product is approved for this use.

Is any stem cell or exosome product FDA approved for diabetic retinopathy & diabetic macular edema?

No cell, exosome or Wharton’s jelly product is FDA-approved for diabetic retinopathy, to our knowledge as of our last review.

References

  1. Eye Conditions and Diseases. National Eye Institute (NIH). [Government health agency · citation details pending reviewer confirmation]
  2. Approved Cellular and Gene Therapy Products. U.S. Food and Drug Administration. [Regulator · citation details pending reviewer confirmation]
  3. FDA Warns About Stem Cell Therapies (consumer update). U.S. Food and Drug Administration. [Regulator · citation details pending reviewer confirmation]
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