Dry Eye Disease and Regenerative Medicine Research
Last medically reviewed: October 7, 2026
What is dry eye disease?
Dry eye disease is a common condition in which the tear film does not adequately lubricate the ocular surface, causing discomfort, irritation and fluctuating vision.
What causes dry eye disease?
Reduced tear production, increased evaporation (often from meibomian gland dysfunction), inflammation, autoimmune conditions such as Sjögren's, medications, and environmental factors.
What structures or cells are affected?
The tear film, ocular surface, meibomian glands and lacrimal glands.
How is dry eye disease currently treated or managed?
- Artificial tears, eyelid hygiene and treatment of meibomian gland dysfunction.
- Prescription anti-inflammatory eye drops and other approved medicines.
- Punctal plugs and in-office procedures in selected cases.
Are these approaches FDA approved for dry eye disease?
● Established / Approved Several prescription medicines are FDA-approved for dry eye disease.[1]
No cell, exosome or Wharton’s jelly product is FDA-approved for dry eye disease, to our knowledge as of our last review.[2]
Why are researchers studying regenerative approaches?
Because inflammation drives many forms of dry eye, researchers have studied the immune-modulating properties of MSCs and their secreted factors, including in dry eye related to graft-versus-host disease.
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 Dry Eye Disease
We have not identified research in this category for dry eye disease that meets our standards for inclusion.
MSC Research and Dry Eye Disease
- ● Early Human ResearchMesenchymal Stromal/Stem Cells (MSCs)
Small early human studies have explored MSCs in severe dry eye associated with graft-versus-host disease. Evidence is preliminary.
EVIDENCE VERIFICATION REQUIRED. Specific studies have not yet been verified by our reviewers. Search the literature: PubMed search: mesenchymal stem cells dry eye graft-versus-host disease
Extracellular Vesicle / Exosome Research and Dry Eye Disease
- ● Preclinical Animal EvidenceExtracellular Vesicles
Extracellular vesicles have been studied in animal models of dry eye.
EVIDENCE VERIFICATION REQUIRED. Specific studies have not yet been verified by our reviewers. Search the literature: PubMed search: extracellular vesicles dry eye
Other Cell-Based Research
We have not identified research in this category for dry eye disease that meets our standards for inclusion.
What Has Been Demonstrated in Laboratory Research?
We have not identified research in this category for dry eye disease that meets our standards for inclusion.
What Has Been Demonstrated in Animal Research?
- ● Preclinical Animal EvidenceExtracellular Vesicles
Extracellular vesicles have been studied in animal models of dry eye.
EVIDENCE VERIFICATION REQUIRED. Specific studies have not yet been verified by our reviewers. Search the literature: PubMed search: extracellular vesicles dry eye
What Human Research Exists?
- ● Early Human ResearchMesenchymal Stromal/Stem Cells (MSCs)
Small early human studies have explored MSCs in severe dry eye associated with graft-versus-host disease. Evidence is preliminary.
EVIDENCE VERIFICATION REQUIRED. Specific studies have not yet been verified by our reviewers. Search the literature: PubMed search: mesenchymal stem cells dry eye graft-versus-host disease
Are Clinical Trials Underway?
Trial status changes often. Search the official U.S. registry directly: Dry Eye + mesenchymal, Dry Eye + 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 MSC, exosome or umbilical-cord-derived products treat dry eye disease.
Potential Biological Mechanisms Researchers Are Investigating
● Mechanistic / TheoreticalRisks 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?
Find an Eye-Care Professional
EyeCyte does not provide medical care. Browse the provider directory by specialty and location, or send us a request. Listing in a directory is not an endorsement of any experimental intervention.
Open the provider directory →Information for Physicians and Researchers
Professional education, research summaries and research-use-only materials are on our professional pages — kept separate from patient information.
Explore Dry Eye Disease
Related research questions
- What does current research say about MSCs and dry eye disease?
- Is MSCs being studied for dry eye disease?
- Are clinical trials investigating MSCs in dry eye disease?
- What preclinical evidence exists involving MSCs and dry eye disease?
- Has MSCs been studied in humans with dry eye disease?
- What are the limitations of current MSCs research for dry eye disease?
- Is MSCs FDA approved for dry eye disease?
- What does current research say about extracellular vesicles and dry eye disease?
- Is extracellular vesicles being studied for dry eye disease?
- Are clinical trials investigating extracellular vesicles in dry eye disease?
- What preclinical evidence exists involving extracellular vesicles and dry eye disease?
- Has extracellular vesicles been studied in humans with dry eye disease?
- What are the limitations of current extracellular vesicles research for dry eye disease?
- Is extracellular vesicles FDA approved for dry eye disease?
Frequently Asked Questions
Are exosome eye drops approved for dry eye?
Not to our knowledge. The FDA has warned consumers about unapproved exosome products.
Is any stem cell or exosome product FDA approved for dry eye disease?
No cell, exosome or Wharton’s jelly product is FDA-approved for dry eye disease, to our knowledge as of our last review.
References
- Eye Conditions and Diseases. National Eye Institute (NIH). [Government health agency · citation details pending reviewer confirmation]
- Approved Cellular and Gene Therapy Products. U.S. Food and Drug Administration. [Regulator · citation details pending reviewer confirmation]
- FDA Warns About Stem Cell Therapies (consumer update). U.S. Food and Drug Administration. [Regulator · citation details pending reviewer confirmation]
- ClinicalTrials.gov: Dry Eye + mesenchymal — ClinicalTrials.gov (NIH National Library of Medicine)
- ClinicalTrials.gov: Dry Eye + exosome — ClinicalTrials.gov (NIH National Library of Medicine)
- PubMed search: mesenchymal stem cells dry eye graft-versus-host disease — PubMed (NIH National Library of Medicine)
- PubMed search: extracellular vesicles dry eye — PubMed (NIH National Library of Medicine)