On 18 November 2016, orphan designation (EU/3/16/1774) was granted by the European Commission to Fate Therapeutics Ltd, United Kingdom, for allogeneic peripheral blood mononuclear cells incubated ex-vivo with 16, 16-dimethyl prostaglandin E2 and dexamethasone (also known as ProTmune) for treatment in haematopoietic stem cell transplantation.
The sponsorship was transferred to Fate Therapeutics B.V., the Netherlands, in May 2019.
Please note that this product was withdrawn from the Union Register of orphan medicinal products in August 2022 on request of the Sponsor.
Treatment in haematopoietic stem cell transplantation
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Fate Therapeutics B.V.
Documents related to this orphan designation evaluation
EU/3/16/1774: Public summary of positive opinion for orphan designation of allogeneic peripheral blood mononuclear cells incubated ex-vivo with 16, 16-dimethyl prostaglandin E2 and dexamethasone for treatment in haematop... (PDF/202.91 KB)
First published: 13/12/2016
Last updated: 10/08/2022
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: