Skip to main content

Clinical trial of autologous adipose-derived mesenchymal stromal cells (ASC) in the treatment of mild to moderate osteoarthritis

Objective

Osteoarthritis (OA) is an incurable disease that has evaded pharmacological interference, biologic therapy or surgical intervention to prevent disease progression. Currently, OA is designated the 11th highest contributor (of 291 diseases) of global disability. In the absence of effective treatment options, cellular therapies using mesenchymal stem/stromal cells (MSCs) have emerged as potential candidates to overcome this clinical short-coming. Autologous adipose-derived mesenchymal stromal cells (ASCs) are attractive for cellular therapy given the abundance of tissue, high frequency of MSCs and minimally invasive harvest procedure. The EU consortium ADIPOA has shown in a ‘first in man’ 2-centre Phase I safety study that intraarticular injection of a single dose of autologous ASCs to the knee (18 patients, 12 month follow-up) was well-tolerated, had no adverse effects, and resulted in an improvement in pain score and functional outcome.
ADIPOA2 will deliver a large-scale clinical trial in regenerative medicine for OA. The purpose of the project is to design and implement a phase IIb study to assess the safety and efficacy of autologous (patient-derived) ACSs in the treatment of advanced OA of the knee. The cells will be prepared from samples of adipose tissue harvested from patients by lipoaspiration.
ADIPOA2 will comprise a multi-centre, randomized clinical trial comparing culture-expanded, autologous adult ASCs in subjects with knee OA with another widely used therapeutic approach for knee degeneration (injection of Hyaluronan). There are two large elements of the study: (1) the production of consistent batches of high-quality autologous ASCs under GMP-compliant conditions and (2) delivery of these cell doses to patients in a trial which will meet all national and European regulatory and ethical standards and which will have sufficient statistical power to provide an unambiguous and definitive assessment of safety and efficacy.

Call for proposal

H2020-PHC-2014-single-stage
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

NATIONAL UNIVERSITY OF IRELAND GALWAY
Address
University Road
H91 Galway
Ireland
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 091 336,09

Participants (18)

ISTITUTO ORTOPEDICO RIZZOLI
Italy
EU contribution
€ 354 600
Address
Via Di Barbiano 1/10
40136 Bologna
Activity type
Research Organisations
ETABLISSEMENT FRANCAIS DU SANG
France
EU contribution
€ 890 430
Address
Avenue Du Stade De France 20
93210 La Plaine Saint Denis
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 157 600
Address
Rue De Tolbiac 101
75654 Paris
Activity type
Research Organisations
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
EU contribution
€ 185 712
Address
5 Rue Watt
75013 Paris
Activity type
Research Organisations
HUMAN MED AG
Germany
EU contribution
€ 73 875
Address
Wilhelm Hennemann Strasse 9
D-19061 Schwerin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
STICHTING KATHOLIEKE UNIVERSITEIT
Netherlands
EU contribution
€ 354 600
Address
Geert Grooteplein Noord 9
6525 EZ Nijmegen
Activity type
Higher or Secondary Education Establishments
SPORTS SURGERY CLINIC LIMITED

Participation ended

Ireland
EU contribution
€ 83 486
Address
Santry Demesne, Santry
Dublin 9 Dublin 9
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITA DEGLI STUDI DI PADOVA
Italy
EU contribution
€ 177 300
Address
Via 8 Febbraio 2
35122 Padova
Activity type
Higher or Secondary Education Establishments
EVANGELISCHES WALDKRANKENHAUS SPANDAU KRANKENHAUSBETRIEBS GGMBH
Germany
EU contribution
€ 246 250
Address
Stadtrandstrasse 555
13589 Berlin
Activity type
Other
PINTAIL LTD
Ireland
EU contribution
€ 193 552,50
Address
Springhill Avenue 77
A94 K542 Blackrock
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS
France
EU contribution
€ 165 207,50
Address
Rue Michel Ange 3
75794 Paris
Activity type
Research Organisations
UNIVERSITAET ULM
Germany
EU contribution
€ 903 738
Address
Helmholtzstrasse 16
89081 Ulm
Activity type
Higher or Secondary Education Establishments
CENTRE HOSPITALIER UNIVERSITAIRE MONTPELLIER
France
EU contribution
€ 434 976
Address
Avenue Du Doyen Gaston Giraud 191
34000 Montpellier
Activity type
Other
Cambridge University Hospitals NHS Foundation Trust
United Kingdom
EU contribution
€ 187 150
Address
Hills Road Addenbrookes Hospital
CB2 0QQ Cambridge
Activity type
Other
Aries srl
Italy
EU contribution
€ 60 825
Address
Via Xxv Luglio 43
41037 Mirandola
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 217 300
Address
3 Avenue Victoria
75000 Paris
Activity type
Research Organisations
CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE
France
EU contribution
€ 177 300
Address
Rue Viguerie 2 Hotel Dieu Saint Jacques
31052 Toulouse Cedex 3
Activity type
Higher or Secondary Education Establishments
CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE
France
EU contribution
€ 43 761,91
Address
Boulevard De La Chantourne
38700 La Tronche
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)