EUCELLEX

Cell-based regenerative medicine: new challenges for EU legislation and governance

Coordinatore	INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)    more  Organization address address: 101 Rue de Tolbiac city: PARIS postcode: 75654 contact info Titolo: Ms. Nome: Muriel Cognome: Bouas Email: send email Telefono: 33562748360 Fax: 33561319752
Nazionalità Coordinatore	France [FR]
Totale costo	559˙840 €
EC contributo	500˙000 €
Programma	FP7-HEALTH Specific Programme "Cooperation": Health
Code Call	FP7-HEALTH-2013-INNOVATION-1
Funding Scheme	CSA-SA
Anno di inizio	2013
Periodo (anno-mese-giorno)	2013-10-01   -   2016-09-30

 Partecipanti

#	participant	country	role	EC contrib. [€]
1	INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)  Organization address address: 101 Rue de Tolbiac city: PARIS postcode: 75654 contact info Titolo: Ms. Nome: Muriel Cognome: Bouas Email: send email Telefono: 33562748360 Fax: 33561319752	FR (PARIS)	coordinator	108˙739.00
2	KOZEP-EUROPAI EGYETEM  Organization address address: Nador utca 9 city: BUDAPEST postcode: 1051 contact info Titolo: Ms. Nome: Eva Cognome: Vas Email: send email Telefono: +36 1 327 3084	HU (BUDAPEST)	participant	53˙029.00
3	FONDATION NATIONALE SCIENCES POLITIQUES  Organization address address: RUE SAINT GUILLAUME 27 city: PARIS CEDEX 07 postcode: 75341 contact info Titolo: Mrs. Nome: Gina Cognome: Sandanassamy Email: send email Telefono: +33 1 45 49 72 97	FR (PARIS CEDEX 07)	participant	53˙004.00
4	THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD  Organization address address: University Offices, Wellington Square city: OXFORD postcode: OX1 2JD contact info Titolo: Dr. Nome: Stephen Cognome: Conway Email: send email Telefono: +44 1865 289800 Fax: +44 1865 289801	UK (OXFORD)	participant	52˙984.00
5	KATHOLIEKE UNIVERSITEIT LEUVEN  Organization address address: Oude Markt 13 city: LEUVEN postcode: 3000 contact info Titolo: Ms. Nome: Karolien Cognome: Mariën Email: send email Telefono: +32 16373024 Fax: +32 16 326515	BE (LEUVEN)	participant	52˙911.00
6	Medizinische Universitaet Graz  Organization address address: AUENBRUGGERPLATZ 2 city: GRAZ postcode: 8036 contact info Titolo: Prof. Nome: Kurt Cognome: Zatloukal Email: send email Telefono: +43 316 380 4404 Fax: +43 316 384 329	AT (GRAZ)	participant	52˙822.00
7	ROYAL INSTITUTION FOR THE ADVANCEMENT OF LEARNING MCGILL UNIVERSITY  Organization address address: SHERBROOKE STREET WEST 845 city: MONTREAL postcode: H3A2T5 contact info Titolo: Prof. Nome: Bartha-Maria Cognome: Knoppers Email: send email Telefono: +001514 398 8866 Fax: +001514 398 8954	CA (MONTREAL)	participant	42˙350.00
8	GOTTFRIED WILHELM LEIBNIZ UNIVERSITAET HANNOVER  Organization address address: Welfengarten 1 city: HANNOVER postcode: 30167 contact info Titolo: Prof. Nome: Nils Cognome: Hoppe Email: send email Telefono: +49 511 762 5192 Fax: +49 511 762 14146	DE (HANNOVER)	participant	42˙217.00
9	LEGAL PATHWAYS BV  Organization address address: KLAPHEKLAAN 8 city: AERDENHOUT postcode: 2111 XS contact info Titolo: Dr. Nome: Jasper Cognome: Bovenberg Email: send email Telefono: +31 6 38757483	NL (AERDENHOUT)	participant	41˙944.00

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 Obiettivo del progetto (Objective)

'This proposal aims at collecting and analysing facts and figures in order to assess the current legislation on the therapeutic use of somatic cells, and to bridge it with the research infrastructure capacity building. Although EU has adopted 3 Directives on Tissues and cells between 2004 and 2006 to harmonise the procurement, storage and use of cells for therapeutic use in Europe, countries have implemented these directives in very different ways. Furthermore, research has been partially covered by the initial regulation, calling into question the match between regulation and practices that will develop in the near future, in particular with the emergence of European research infrastructures. Finally many changes have occurred in the scientific, legal and institutional environment of cell use, leading to a necessary update of this regulation with regards to its implementation in national legislation and its impact on research practice and innovation. Two domains are at stake: research (infrastructures) and medical practice/public health measures (cells). The therapeutic use of cells is regulated by EU law whereas its research counterpart is mainly depending on national laws and regulations. This gap calls for a coordinated action in order to optimize the translational process, since the full pipeline is not coherently taken into account in current legislations. To achieve these objectives, our project relies on a coherent consortium of experts in the fields of cells therapies, cells banks and translational biomedicine, having strong expertise in law and/ or in governance issues. After 36 months the project will deliver evidence about the contemporary practices around cells and will design a picture of the “market” and its distribution between the public and private sector. The project will thus help the Commission in the regulatory choices covering the use of human cells for therapeutic purposes and to foster the innovation potential of related research activities.'