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

Holoclar is indicated for patients with limbal stem‑cell deficiency and for those who have sustained severe ocular surface damage that impairs vision and comfort, when standard therapies are insufficient.

• Restores a functional corneal epithelium in unilateral limbal stem‑cell deficiency.
• Treats bilateral limbal stem‑cell deficiency when autologous tissue is available.
• Addresses severe ocular surface disease caused by chemical burns.
• Manages thermal‑injury‑related corneal damage unresponsive to medical therapy.
• Provides an option for patients unsuitable for donor corneal transplantation.
• Facilitates long‑term ocular surface stability after successful implantation.

• Holoclar works by transplanting a laboratory‑expanded sheet of the patient’s own corneal epithelial cells that include limbal stem cells. After surgical placement onto the damaged corneal surface, the autologous cells integrate into the limbal niche, differentiate into mature epithelial cells, and repopulate the cornea, thereby re‑establishing a self‑renewing barrier and restoring transparency. The therapy leverages the patient’s innate regenerative capacity without systemic immunosuppression.

Adverse reactions reported after Holoclar implantation vary in frequency and severity; they are generally related to the surgical procedure, the cell product, and postoperative care, and patient factors.

Common

• Mild ocular discomfort or foreign‑body sensation.
• Transient redness or conjunctival injection.
• Temporary decrease in visual acuity.
• Mild epithelial edema at the graft site.
• Low‑grade inflammation resolving within weeks.
• Mild tearing that resolves spontaneously.
• Transient photophobia.

Serious

• Graft failure requiring repeat surgery.
• Persistent epithelial defect leading to corneal ulceration.
• Significant intra‑ocular inflammation or uveitis.
• Infection of the surgical site, including bacterial keratitis.
• Delayed graft integration causing prolonged visual impairment.
• Allergic reaction to peri‑operative medications.

Before using Holoclar, clinicians should evaluate patient suitability and adhere to specific safety measures to minimize procedural risks and optimize outcomes.

• Confirm diagnosis of limbal stem‑cell deficiency and assess availability of autologous tissue.
• Perform thorough ocular surface examination, including slit‑lamp and imaging studies.
• Exclude active ocular infection or uncontrolled inflammation prior to implantation.
• Ensure patient compliance with postoperative medication regimen and follow‑up visits.
• Discuss potential need for repeat transplantation if graft failure occurs.
• Avoid use in patients with systemic conditions that impair wound healing, such as uncontrolled diabetes.

Holoclar is a localized cell‑based therapy, but certain concomitant treatments may affect graft survival or increase ocular complications.

Avoid

• Topical corticosteroids at high potency that delay epithelial healing.
• Systemic immunosuppressants that alter wound‑repair mechanisms without clear benefit.
• Antimetabolite eye drops (e.g., mitomycin C) applied near the graft site.
• Preservative‑containing eye drops that may be toxic to the graft.

Use with caution

• Low‑dose topical steroids to control inflammation, monitored closely.
• Non‑steroidal anti‑inflammatory eye drops, which may affect clotting.
• Antiviral or antibacterial prophylaxis when infection risk is present.
• Contact lens wear during the early postoperative period, which may increase mechanical stress.