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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-2014-2015

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Sub call

H2020-PHC-2014-single-stage

Coordinator

NATIONAL UNIVERSITY OF IRELAND GALWAY
Net EU contribution
€ 1 091 336,09
Address
University Road
H91 Galway
Ireland

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Region
Ireland Eastern and Midland Dublin
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00

Participants (20)

ISTITUTO ORTOPEDICO RIZZOLI
Italy
Net EU contribution
€ 354 600,00
Address
Via Di Barbiano 1/10
40136 Bologna

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Region
Nord-Est Emilia-Romagna Bologna
Activity type
Research Organisations
Other funding
€ 0,00
ETABLISSEMENT FRANCAIS DU SANG
France
Net EU contribution
€ 890 430,00
Address
Avenue Du Stade De France 20
93210 La Plaine Saint Denis

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Region
Ile-de-France Ile-de-France Seine-Saint-Denis
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
Net EU contribution
€ 157 600,00
Address
Rue De Tolbiac 101
75654 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 0,00
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
Net EU contribution
€ 185 712,00
Address
5 Rue Watt
75013 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

ISTITUTO SUPERIORE DI SANITA

Participation ended

Italy
Net EU contribution
€ 0,00
Address
Viale Regina Elena 299
00161 Roma
Region
Centro (IT) Lazio Roma
Activity type
Research Organisations
Other funding
€ 0,00
HUMAN MED AG
Germany
Net EU contribution
€ 73 875,00
Address
Wilhelm Hennemann Strasse 9
D-19061 Schwerin

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Mecklenburg-Vorpommern Mecklenburg-Vorpommern Schwerin, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
STICHTING RADBOUD UNIVERSITEIT
Netherlands
Net EU contribution
€ 354 600,00
Address
Houtlaan 4
6525 XZ Nijmegen

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Region
Oost-Nederland Gelderland Arnhem/Nijmegen
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
SPORTS SURGERY CLINIC LIMITED

Participation ended

Ireland
Net EU contribution
€ 83 486,00
Address
Santry Demesne, Santry
Dublin 9 Dublin 9
Region
Ireland Eastern and Midland Dublin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
UNIVERSITA DEGLI STUDI DI PADOVA
Italy
Net EU contribution
€ 177 300,00
Address
Via 8 Febbraio 2
35122 Padova

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Region
Nord-Est Veneto Padova
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
EVANGELISCHES WALDKRANKENHAUS SPANDAU KRANKENHAUSBETRIEBS GGMBH
Germany
Net EU contribution
€ 246 250,00
Address
Stadtrandstrasse 555
13589 Berlin

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Region
Berlin Berlin Berlin
Activity type
Other
Other funding
€ 0,00
PINTAIL LTD
Ireland
Net EU contribution
€ 193 552,50
Address
Springhill Avenue 77
A94 K542 Blackrock

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Ireland Eastern and Midland Dublin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS
France
Net EU contribution
€ 150 495,00
Address
Rue Michel Ange 3
75794 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

UNIVERSITE PAUL SABATIER TOULOUSE III
France
Net EU contribution
€ 14 712,50
Address
Route De Narbonne 118
31062 Toulouse Cedex 9

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Region
Occitanie Midi-Pyrénées Haute-Garonne
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITAET ULM
Germany
Net EU contribution
€ 903 738,00
Address
Helmholtzstrasse 16
89081 Ulm

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Region
Baden-Württemberg Tübingen Ulm, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
CENTRE HOSPITALIER UNIVERSITAIRE MONTPELLIER
France
Net EU contribution
€ 434 976,00
Address
Avenue Du Doyen Gaston Giraud 191
34000 Montpellier

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Region
Occitanie Languedoc-Roussillon Hérault
Activity type
Research Organisations
Other funding
€ 0,00
Cambridge University Hospitals NHS Foundation Trust
United Kingdom
Net EU contribution
€ 187 150,00
Address
Hills Road Addenbrookes Hospital
CB2 0QQ Cambridge

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Region
East of England East Anglia Cambridgeshire CC
Activity type
Other
Other funding
€ 0,00
Aries srl
Italy
Net EU contribution
€ 60 825,00
Address
Via Xxv Luglio 43
41037 Mirandola

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Region
Nord-Est Emilia-Romagna Modena
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
Net EU contribution
€ 217 300,00
Address
3 Avenue Victoria
75000 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 0,00
CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE
France
Net EU contribution
€ 177 300,00
Address
Rue Viguerie 2 Hotel Dieu Saint Jacques
31052 Toulouse Cedex 3

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Region
Occitanie Midi-Pyrénées Haute-Garonne
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE
France
Net EU contribution
€ 43 761,91
Address
Boulevard De La Chantourne
38700 La Tronche

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Region
Auvergne-Rhône-Alpes Rhône-Alpes Isère
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00