Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Holostem Terapie Avanzate s.r.l., Via Glauco Gottardi 100, 41125 Modena, Italy Telephone: +39 059 2058070 Telefax: +39 059 2058115
Holoclar 79,000 – 316,000 cells/cm² living tissue equivalent.
| Pharmaceutical Form |
|---|
|
Living tissue equivalent. Transparent, circular sheet. |
Ex vivo expanded autologous human corneal epithelial cells containing stem cells.
Holoclar consists of a transparent circular sheet of 300,000 to 1,200,000 viable autologous human corneal epithelial cells (79,000 – 316,000 cells/cm²), including on average 3.5% (0.4 to 16%) limbal stem cells, and stem cell-derived transient amplifying and terminally differentiated cells, attached on a supportive 2.2 cm diameter fibrin layer and maintained in the transport medium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Limbal stem cells |
The mechanism of action of limbal stem cells implantation is the replacement of corneal epithelium and lost limbal stem cells in patients in which the limbus has been destroyed by ocular burns. During the corneal repair process, the administered stem cells are intended to partially multiply, differentiate and migrate to regenerate corneal epithelium, as well as maintaining a reservoir of stem cells that can continually regenerate the corneal epithelium. |
| List of Excipients |
|---|
|
Transport medium (Dulbecco’s Modified Eagles Medium supplemented with L-glutamine) |
Holoclar is supplied as one individual treatment dose contained in a screw-cap container. Each container contains 3.8 cm² of autologous human corneal epithelium attached on a fibrin support and covered with transport medium.
The container is put in a secondary plastic container which is then put in a sealed sterile plastic bag. The sealed bag is put in a non-sterile, thermally insulated box for organ transportation with a temperature monitor. Finally, the thermally insulated box is put in a zipped sealable bag for transportation.
Holostem Terapie Avanzate s.r.l., Via Glauco Gottardi 100, 41125 Modena, Italy
Telephone: +39 059 2058070
Telefax: +39 059 2058115
EU/1/14/987/001
Date of first authorisation: 17/02/2015
Date of latest renewal: 09/12/2021
| Drug | Countries | |
|---|---|---|
| HOLOCLAR | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom |
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