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

Holoclar is indicated for the treatment of moderate to severe limbal stem‑cell deficiency (LSCD) that results from ocular surface burns in adult patients.

• Restores a healthy corneal epithelium in eyes with LSCD caused by chemical or thermal injury.
• Improves corneal transparency and reduces the risk of persistent epithelial defects.
• May be considered when conventional medical therapy (e.g., lubricants, bandage contact lenses) has failed.
• Can be used as part of a staged surgical plan that includes amniotic membrane transplantation or keratoplasty.
• Provides an autologous source of stem cells, minimizing the need for donor tissue.

• Holoclar delivers a suspension of autologous human corneal epithelial cells that have been expanded ex vivo and enriched for limbal stem cells. After surgical implantation onto the diseased corneal surface, the cells adhere, proliferate, and differentiate to re‑epithelialize the cornea. The stem‑cell population repopulates the limbal niche, restoring normal epithelial turnover and barrier function, thereby effectively clinically correcting the underlying deficiency.

Adverse reactions reported after Holoclar implantation involve the ocular surface and, less frequently, systemic events.

Common

• Mild conjunctival hyperemia or redness at the implantation site.
• Transient foreign‑body sensation or mild irritation.
• Temporary decrease in visual acuity due to corneal edema.
• Mild epithelial irregularities that resolve within weeks.
• Mild ocular discomfort or tearing that resolves within a few days.
• Transient increase in intra‑ocular pressure that normalizes without intervention.

Serious

• Persistent epithelial defect leading to corneal ulceration.
• Graft rejection or inflammatory infiltrates requiring intensified immunosuppression.
• Endophthalmitis or intra‑ocular infection.
• Significant loss of visual acuity that does not improve with standard care.
• Formation of neovascularization at the graft site, potentially compromising corneal clarity.
• Allergic reaction to adjunctive medications used during the procedure, such as topical antibiotics.

Before using Holoclar, clinicians should evaluate patient suitability and follow specific safety measures to minimise risks.

• Confirm diagnosis of limbal stem‑cell deficiency and document the extent of ocular surface damage.
• Verify that the patient is an adult and that autologous cell harvesting is feasible.
• Assess for active ocular infection; postpone implantation until infection is resolved.
• Ensure adequate control of systemic conditions that may impair wound healing, such as uncontrolled diabetes.
• Review any history of hypersensitivity to components used in the cell‑culture process.
• Discuss the need for postoperative immunosuppressive therapy and close follow‑up.
• Counsel patients on the possibility of graft failure and the requirement for additional interventions.

Holoclar is a cell‑based product, and its safety profile can be affected by concomitant ocular or systemic therapies.

Avoid

• Use of topical corticosteroids at high potency immediately before implantation, which may impair cell engraftment.
• Administration of systemic immunosuppressants that significantly suppress wound‑healing pathways during the early postoperative period.

Use with caution

• Concurrent use of anti‑VEGF eye drops, which could interfere with neovascular regression needed for graft stability.
• Topical antibiotics or antiseptics that contain preservatives known to be toxic to corneal epithelial cells.
• Systemic chemotherapy agents, as they may reduce the viability of autologous stem cells.
• Any investigational ocular product applied within 30 days of the Holoclar procedure.