Limbal Stem Cell Deficiency & Corneal Damage and Regenerative Medicine Research

What is limbal stem cell deficiency & corneal damage?

Limbal stem cell deficiency (LSCD) occurs when the stem cells at the edge of the cornea (the limbus) are damaged or lost, so the corneal surface can no longer renew itself normally. Chemical and thermal burns are common causes.

What causes limbal stem cell deficiency & corneal damage?

Chemical or thermal injury, certain inflammatory diseases, contact-lens-related injury, surgery and some genetic conditions.

What structures or cells are affected?

The limbal stem cells and the corneal epithelium.

How is limbal stem cell deficiency & corneal damage currently treated or managed?

• Management by a cornea specialist.
• Depending on severity, surgical approaches that transplant limbal tissue from the healthy eye or a donor.

Are these approaches FDA approved for limbal stem cell deficiency & corneal damage?

● Established / Approved In the European Union, a cultivated autologous limbal stem cell product (Holoclar) received conditional marketing authorisation in 2015 for LSCD after eye burns. This is an EU authorisation, not an FDA approval.^[1]

We are not aware of an FDA-approved cultivated limbal stem cell product as of our last review; confirm current status with a cornea specialist.^[3]

Why are researchers studying regenerative approaches?

Limbal stem cells are the eye's own corneal-surface stem cells — one of the few areas where stem-cell-based approaches have reached established clinical use in some jurisdictions.

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 Limbal Stem Cell Deficiency & Corneal Damage

• ● Human Clinical EvidenceLimbal Stem Cells

  Long-term clinical follow-up of cultivated limbal stem cell transplantation for burn-related LSCD has been published.^[2]

MSC Research and Limbal Stem Cell Deficiency & Corneal Damage

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

  MSCs have been studied for corneal surface repair in animal models.

  EVIDENCE VERIFICATION REQUIRED. Specific studies have not yet been verified by our reviewers. Search the literature: PubMed search: mesenchymal stem cells limbal stem cell deficiency

Extracellular Vesicle / Exosome Research and Limbal Stem Cell Deficiency & Corneal Damage

We have not identified research in this category for limbal stem cell deficiency & corneal damage that meets our standards for inclusion.

Other Cell-Based Research

We have not identified research in this category for limbal stem cell deficiency & corneal damage that meets our standards for inclusion.

Are Clinical Trials Underway?

Trial status changes often. Search the official U.S. registry directly: Limbal Stem Cell Deficiency + limbal. A registered trial is not an endorsement, and registration does not mean a treatment works.

What Has NOT Yet Been Proven

• That MSC or exosome products are effective for LSCD.

Potential Biological Mechanisms Researchers Are Investigating

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?

Related research questions

• What does current research say about limbal stem cells and limbal stem cell deficiency & corneal damage?
• Is limbal stem cells being studied for limbal stem cell deficiency & corneal damage?
• Are clinical trials investigating limbal stem cells in limbal stem cell deficiency & corneal damage?
• What preclinical evidence exists involving limbal stem cells and limbal stem cell deficiency & corneal damage?
• Has limbal stem cells been studied in humans with limbal stem cell deficiency & corneal damage?
• What are the limitations of current limbal stem cells research for limbal stem cell deficiency & corneal damage?
• Is limbal stem cells FDA approved for limbal stem cell deficiency & corneal damage?
• What does current research say about MSCs and limbal stem cell deficiency & corneal damage?
• Is MSCs being studied for limbal stem cell deficiency & corneal damage?
• Are clinical trials investigating MSCs in limbal stem cell deficiency & corneal damage?
• What preclinical evidence exists involving MSCs and limbal stem cell deficiency & corneal damage?
• Has MSCs been studied in humans with limbal stem cell deficiency & corneal damage?
• What are the limitations of current MSCs research for limbal stem cell deficiency & corneal damage?
• Is MSCs FDA approved for limbal stem cell deficiency & corneal damage?

Frequently Asked Questions