Holoclar (Ex Vivo Expanded Autologous Human Corneal Epithelial Cells Containing Stem Cells)

Holoclar is indicated for the reconstruction of the ocular surface in patients with limbal stem‑cell deficiency caused by ocular burns.

• Restoration of corneal epithelium in unilateral limbal stem‑cell deficiency.
• Treatment of persistent epithelial defects after chemical injury.
• Adjunct therapy following surgical removal of scar tissue in the limbal region.
• Use in cases where autologous limbal tissue can be harvested and expanded ex vivo.
• Consideration for patients with partial limbal loss where conventional grafts are unsuitable.

• Holoclar provides autologous corneal epithelial stem cells that have been expanded ex vivo and formed into a contiguous cell sheet. When implanted onto the damaged limbal niche, the cells adhere to the stromal matrix, proliferate, and differentiate into mature epithelial cells, thereby repopulating the corneal surface. The presence of resident stem cells re‑establishes the normal limbal barrier, supporting long‑term regeneration and maintenance of a transparent corneal epithelium.

Adverse reactions reported after Holoclar implantation involve ocular and systemic events, most of which are mild and transient.

Common

• Conjunctival hyperemia
• Mild ocular irritation or foreign‑body sensation
• Transient increase in intra‑ocular pressure
• Mild corneal edema

Serious

• Graft failure or loss of epithelial integrity
• Infectious keratitis
• Neovascularization of the cornea

Clinicians should observe several precautions before and after Holoclar implantation to minimize complications.

• Verify that sufficient autologous limbal tissue can be harvested without compromising the donor eye.
• Perform a thorough ocular surface assessment to rule out active infection.
• Ensure proper storage and handling of the cell sheet according to manufacturer guidelines.
• Monitor intra‑ocular pressure and corneal thickness during the postoperative period.
• Advise patients to avoid eye rubbing and exposure to contaminants.
• Schedule regular follow‑up examinations to assess graft integration.
• Use systemic immunosuppression only if indicated, as the product is autologous.

Holoclar may interact with other ocular medications or systemic agents that affect wound healing or immune response.

Avoid

• Topical corticosteroids at high potency immediately after implantation without physician supervision.
• Systemic immunosuppressants unless specifically prescribed for graft rejection.
• Antifungal or antiviral eye drops that contain preservatives known to be toxic to corneal epithelium.

Use with caution

• Preservative‑free lubricants and antibiotics, monitoring for delayed epithelial healing.
• Anti‑VEGF agents if neovascularization develops, balancing risk of impaired graft survival.
• Contact lens wear, ensuring proper fitting and hygiene to prevent mechanical trauma.