ex vivo expanded autologous human corneal epithelial cells containing stem cells

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Holoclar. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Holoclar.

For practical information about using Holoclar, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 06/01/2022

Authorisation details

Product details
Agency product number
Active substance
ex vivo expanded autologous human corneal epithelial cells containing stem cells
International non-proprietary name (INN) or common name
ex vivo expanded autologous human corneal epithelial cells containing stem cells
Therapeutic area (MeSH)
  • Stem Cell Transplantation
  • Corneal Diseases
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Holostem Terapie Avanzate s.r.l.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Holostem Terapie Avanzate s.r.l.
Via Glauco Gottardi 100
41125 Modena

Product information

09/12/2021 Holoclar - EMEA/H/C/002450 - R/0039

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic 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.

Assessment history

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