REGENER-AR

Bringing Regenerative Medicine into the market: Allogeneic eASCs Phase IB/IIA clinical trial for treating Rheumatoid Arthritis

Coordinatore	TiGENIX NV    more  Organization address address: RESEARCHPARK HAASRODE 1724 ROMEINSE STRAAT 12/2 city: LEUVEN postcode: 3001 contact info Titolo: Ms. Nome: Claudia Cognome: D'augusta Email: send email Telefono: +3201639 60 60
Nazionalità Coordinatore	Belgium [BE]
Totale costo	7˙644˙045 €
EC contributo	5˙925˙461 €
Programma	FP7-HEALTH Specific Programme "Cooperation": Health
Code Call	FP7-HEALTH-2011-two-stage
Funding Scheme	CP-FP
Anno di inizio	2012
Periodo (anno-mese-giorno)	2012-01-01   -   2014-12-31

 Partecipanti

#	participant	country	role	EC contrib. [€]
1	TiGENIX NV  Organization address address: RESEARCHPARK HAASRODE 1724 ROMEINSE STRAAT 12/2 city: LEUVEN postcode: 3001 contact info Titolo: Ms. Nome: Claudia Cognome: D'augusta Email: send email Telefono: +3201639 60 60	BE (LEUVEN)	coordinator	1˙341˙960.00
2	TIGENIX SA  Organization address address: CALLE MARCONI 1 city: TRES CANTONS postcode: 28760 contact info Titolo: Mr. Nome: Maria Cognome: Carballo Email: send email Telefono: 34918063089	ES (TRES CANTONS)	participant	1˙589˙000.00
3	SISTEMIC SCOTLAND LIMITED  Organization address address: CENTRE FOR INTEGRATED DIAGNOSTIC city: GLASGOW postcode: G12 8QQ contact info Titolo: Mr. Nome: Cameron Cognome: Wilson Email: send email Telefono: +44 141 330 1683 Fax: +44 141 330 2062	UK (GLASGOW)	participant	596˙117.60
4	CENTRO DE INVESTIGACIONES ENERGETICAS, MEDIOAMBIENTALES Y TECNOLOGICAS-CIEMAT  Organization address address: Avenida Complutense 22 city: MADRID postcode: 28040 contact info Titolo: Ms. Nome: Ana Cognome: Collados Martín-Posadillo Email: send email Telefono: +34 91 346 6411	ES (MADRID)	participant	445˙879.50
5	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: Mr. Nome: William Cognome: Lepetit Email: send email Telefono: +33 4 67 63 70 23 Fax: +33 4 67 63 02 92	FR (PARIS)	participant	413˙100.00
6	FARMA-CROS IBERICA S.L.  Organization address address: CASTILLA LA MANCHA. POLIGONO INDUSTRIAL CAMPORROSSO 7 city: ALBACETE postcode: 2520 contact info Titolo: Mr. Nome: Juan Cognome: López-Belmonte Pascual Email: send email Telefono: 34967260186	ES (ALBACETE)	participant	377˙200.00
7	ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM  Organization address address: 's Gravendijkwal 230 city: ROTTERDAM postcode: 3015CE contact info Titolo: Mr. Nome: Radjan Cognome: Biharie Email: send email Telefono: +31 107035505	NL (ROTTERDAM)	participant	316˙291.20
8	"ZABALA INNOVATION CONSULTING, S.A."  Organization address address: Paseo Santxiki 3 bis city: Mutilva Alta (Navarra) postcode: 31192 contact info Titolo: Ms. Nome: Laura Cognome: Ezcurra Email: send email Telefono: 34948198000	ES (Mutilva Alta (Navarra))	participant	308˙790.00
9	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	293˙043.20
10	MONDRAGON ASSEMBLY SOCIEDAD COOPERATIVA  Organization address address: POLIGONO INDUSTRIAL BAINETXE 5A city: ARETXABALETA postcode: 20550 contact info Titolo: Mr. Nome: Jean Cognome: Philippe Aguerre Email: send email Telefono: +34 943 712 080	ES (ARETXABALETA)	participant	244˙080.00

Mappa

 Word cloud

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 Obiettivo del progetto (Objective)

'Treating Rheumatoid Arthritis (RA) is a crucial challenge for the health systems. RA is the most common inflammatory arthritis, affecting 0.5% to 1% of the general population worldwide with little variation of the prevalence among countries. The current pharmacological management of RA involves early intervention with synthetic disease modifying anti-rheumatic drugs (DMARDs) either singly or in combination. Despite all those treatments, RA remains as an unmet clinical need where several concerns about long term treatments based on biologics have been arisen (Bongartz, 2009) while there are still approximately 20-40% of rheumathoid arthritis patients that do not have an adequate response to anti-TNF (Vander CB, 2006). The preclinical data obtained by the REGENER-AR consortium in a RA efficacy model in mice using allogeneic eASCs by intravenous route, demonstrated that mesenchymal expanded adult stem cells (eASC) extracted from adipose tissue have a large potential for treating RA. REGENER-AR consortium has defined a clinical translational project which aim is to develop a broadly available and clinically applicable treatment for RA by exploiting the biology of living human eASCs. To do that, the consortium is developing an Advanced Therapy Medicinal Product (ATMP) based on allogeneic eASCs for the treatment of RA (product internal code, Cx611) and ready for starting the clinical research (IMPD and clinical protocol has been approved by the regulatory agencies in January 2011). To accomplish this goal, it will be necessary to test this product through a phase Ib/IIa clinical trial in order to define the safety and feasibility of the systemic administration of allogeneic eASCS in patients with RA, but it will be necessary as well to advance in the difficulties that prevent cell therapy to be considered as a largely available product in the market facing several issues related to the production scale-up, effectively clinical treatment and regulatory affairs compilance'

Introduzione (Teaser)

EU scientists are developing a new treatment for rheumatoid arthritis (RA) based on the intravenous administration of allogeneic mesenchymal stem cells (MSCs) from fat tissue. Initial results showed that MSC therapy lead to a promising clinical outcome in treated patients