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.

• Limbal stem cell deficiency caused by chemical injury.
• Limbal stem cell deficiency caused by thermal injury.
• Limbal stem cell deficiency associated with chronic ocular surface disease.
• Cases where conventional grafts have failed or are not feasible.
• LSCD resulting from Stevens‑Johnson syndrome or ocular cicatricial pemphigoid.
• LSCD after multiple ocular surgeries where limbal tissue is compromised.

• Holoclar works by delivering autologous corneal epithelial stem cells directly onto the damaged limbal niche. The expanded cells adhere to the recipient’s stromal surface, where they integrate into the basal epithelial layer and re‑establish a functional stem‑cell reservoir. Through cell‑cell signaling and extracellular matrix interactions, the graft promotes proliferation and differentiation of a healthy corneal epithelium, restoring barrier function and transparency.

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

Common

• Conjunctival hyperemia (redness of the eye) – typically resolves within days.
• Mild ocular discomfort or foreign‑body sensation at the implantation site.
• Transient epithelial defect at the graft margin that heals spontaneously.
• Mild anterior chamber reaction (cells/flare) without visual loss.

Serious

• Graft failure requiring repeat implantation or alternative therapy.
• Persistent epithelial defect leading to corneal ulceration or scarring.
• Severe intra‑ocular inflammation (uveitis) that may threaten vision.
• Endophthalmitis or other infectious complications requiring urgent treatment.

Before using Holoclar, clinicians should evaluate patient history and ocular condition to minimize risks.

• Confirm adequate autologous limbal tissue can be harvested without compromising the donor eye.
• Exclude active ocular infection or uncontrolled inflammation at the time of implantation.
• Assess for systemic immunosuppression; although autologous, rare immune reactions may occur.
• Monitor intra‑ocular pressure closely during the postoperative period.
• Advise patients to avoid rubbing the eye and to follow prescribed postoperative medication regimen.
• Document any prior ocular surgeries that may affect graft integration.

Holoclar is a cell‑based product, and drug‑drug interactions are limited, but certain agents may affect graft outcome.

Avoid

• Topical corticosteroids at high potency that may impair epithelial healing.
• Antimetabolite eye drops (e.g., mitomycin C) applied near the graft site.
• Systemic immunosuppressants that could alter stem‑cell viability during manufacturing.

Use with caution

• Topical non‑steroidal anti‑inflammatory drugs (NSAIDs) that may delay corneal re‑epithelialization.
• Anti‑vascular endothelial growth factor (anti‑VEGF) agents if neovascularization is present.
• Any ocular medication that induces significant ocular surface dryness.