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🇪🇺EU · EMAAuthorisedATC: S01XA19

Holoclar(ex vivo expanded autologous human corneal epithelial cells containing stem cells)

Stem Cell Transplantation;Corneal Diseases

Marketing Authorisation Holder: Holostem s.r.l.

EMA Authorisation: 17/02/2015

INN: ex vivo expanded autologous human corneal epithelial cells containing stem cells

Indication

Treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least two corneal quadrants, with central corneal involvement, and severely impaired visual acuity), unilateral or bilateral, due to physical or chemical ocular burns. A minimum of 1-2 mm2 of undamaged limbus is required for biopsy.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.