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

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

Call for proposal

FP7-HEALTH-2011-two-stage
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

TIGENIX NV
Address
Romeinse Straat 12/2 Research Park Haasrode 1724
3001 Leuven
Belgium
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 1 341 960
Administrative Contact
Claudia D'augusta (Ms.)

Participants (9)

TIGENIX SA
Spain
EU contribution
€ 1 589 000
Address
Calle Marconi 1
28760 Tres Cantons
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Maria Carballo (Mr.)
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Netherlands
EU contribution
€ 316 291,20
Address
Dr Molewaterplein 40
3015 GD Rotterdam
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Radjan Biharie (Mr.)
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
EU contribution
€ 293 043,20
Address
Wellington Square University Offices
OX1 2JD Oxford
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Stephen Conway (Dr.)
CENTRO DE INVESTIGACIONES ENERGETICAS, MEDIOAMBIENTALES Y TECNOLOGICAS-CIEMAT
Spain
EU contribution
€ 445 879,50
Address
Avenida Complutense 40
28040 Madrid
Activity type
Research Organisations
Administrative Contact
Ana Collados Martín-Posadillo (Ms.)
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 413 100
Address
Rue De Tolbiac 101
75654 Paris
Activity type
Research Organisations
Administrative Contact
William Lepetit (Mr.)
MONDRAGON ASSEMBLY SOCIEDAD COOPERATIVA
Spain
EU contribution
€ 244 080
Address
Poligono Industrial Bainetxe 5A
20550 Aretxabaleta
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jean Philippe Aguerre (Mr.)
FARMA-CROS IBERICA S.L.
Spain
EU contribution
€ 377 200
Address
Castilla La Mancha. Poligono Industrial Camporrosso 7
02520 Albacete
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Juan López-Belmonte Pascual (Mr.)
SISTEMIC SCOTLAND LIMITED
United Kingdom
EU contribution
€ 596 117,60
Address
Centre For Integrated Diagnostic
G12 8QQ Glasgow
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Cameron Wilson (Mr.)
ZABALA INNOVATION CONSULTING, S.A.
Spain
EU contribution
€ 308 790
Address
Paseo Santxiki 3 Bis
31192 Mutilva Alta Navarra
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Laura Ezcurra (Ms.)