On 26 August 2005, orphan designation (EU/3/05/303) was granted by the European Commission to Cellerix S.L., Spain, for human autologous mesenchymal adult stem cells extracted from adipose tissue for the treatment of anal fistula.
Please note that this product was withdrawn from the Union Register of orphan medicinal products in July 2022 on request of the Sponsor.
For a list of the administrative updates to this public summary of opinion, please refer to the PDF document below.
Human autologous mesenchymal adult stem cells extracted from adipose tissue
Treatment of anal fistula
|Orphan designation status||
|EU designation number||
|Date of designation||
|June 2022||The sponsor’s name was updated to TiGenix S.A. in June 2022.|
|February 2013||The sponsor changed name to TiGenix S.A.U. in February 2013.|
|September 2008||The sponsor changed name to Cellerix S.A. in September 2008.|
Documents related to this orphan designation evaluation
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: