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ADIPOA2 SIGNED

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

Total Cost €

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EC-Contrib. €

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Partnership

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 ADIPOA2 project word cloud

Explore the words cloud of the ADIPOA2 project. It provides you a very rough idea of what is the project "ADIPOA2" about.

disease    unambiguous    ed    contributor    stem    intraarticular    functional    randomized    options    first    standards    patient    designated    meet    adipoa    abundance    therapeutic    tissue    pharmacological    clinical    cell    291    incurable    coming    national    frequency    improvement    global    stromal    evaded    autologous    sufficient    knee    12    therapy    progression    dose    centre    interference    gmp    absence    quality    statistical    score    efficacy    surgical    samples    patients    pain    regenerative    single    oa    highest    11th    adult    culture    shown    procedure    candidates    had    consistent    regulatory    therapies    trial    tolerated    prevent    prepared    hyaluronan    subjects    intervention    purpose    diseases    adverse    medicine    harvested    minimally    mscs    disability    expanded    iib    follow    biologic    comprise    invasive    treatment    power    cellular    definitive    injection    attractive    18    cells    outcome    ethical    adipose    compliant    doses    lipoaspiration    acss    man    degeneration    mesenchymal    overcome    emerged    adipoa2    safety    harvest    batches    ascs    osteoarthritis   

Project "ADIPOA2" data sheet

The following table provides information about the project.

Coordinator
NATIONAL UNIVERSITY OF IRELAND GALWAY 

Organization address
address: UNIVERSITY ROAD
city: Galway
postcode: H91
website: www.nuigalway.ie

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Ireland [IE]
 Project website http://adipoa2.eu/
 Total cost 5˙999˙000 €
 EC max contribution 5˙999˙000 € (100%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-PHC-2014-single-stage
 Funding Scheme RIA
 Starting year 2015
 Duration (year-month-day) from 2015-01-01   to  2019-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    NATIONAL UNIVERSITY OF IRELAND GALWAY IE (Galway) coordinator 1˙091˙336.00
2    UNIVERSITAET ULM DE (ULM) participant 903˙738.00
3    ETABLISSEMENT FRANCAIS DU SANG FR (LA PLAINE SAINT DENIS) participant 890˙430.00
4    CENTRE HOSPITALIER UNIVERSITAIRE MONTPELLIER FR (MONTPELLIER) participant 434˙976.00
5    ISTITUTO ORTOPEDICO RIZZOLI IT (BOLOGNA) participant 354˙600.00
6    STICHTING KATHOLIEKE UNIVERSITEIT NL (NIJMEGEN) participant 354˙600.00
7    EVANGELISCHES WALDKRANKENHAUS SPANDAU KRANKENHAUSBETRIEBS GGMBH DE (BERLIN) participant 246˙250.00
8    ASSISTANCE PUBLIQUE HOPITAUX DE PARIS FR (PARIS) participant 217˙300.00
9    PINTAIL LTD IE (Blackrock) participant 193˙552.00
10    Cambridge University Hospitals NHS Foundation Trust UK (CAMBRIDGE) participant 187˙150.00
11    ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK FR (PARIS) participant 185˙712.00
12    CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE FR (TOULOUSE CEDEX 3) participant 177˙300.00
13    UNIVERSITA DEGLI STUDI DI PADOVA IT (PADOVA) participant 177˙300.00
14    CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS FR (PARIS) participant 165˙207.00
15    INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE FR (PARIS) participant 157˙600.00
16    SPORTS SURGERY CLINIC LIMITED IE (Dublin 9) participant 83˙486.00
17    HUMAN MED AG DE (SCHWERIN) participant 73˙875.00
18    Aries srl IT (Mirandola) participant 60˙825.00
19    CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE FR (LA TRONCHE) participant 43˙761.00

Map

 Project 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.

 Deliverables

List of deliverables.
Website Other 2020-02-26 14:33:22
Patient Information Templates Documents, reports 2020-02-26 14:33:22

Take a look to the deliverables list in detail:  detailed list of ADIPOA2 deliverables.

 Publications

year authors and title journal last update
List of publications.
2019 Stephanie C. M. van Dalen, Arjen B. Blom, Birgitte Walgreen, Annet W. Slöetjes, Monique M. A. Helsen, Edwin J. W. Geven, Menno ter Huurne, Thomas Vogl, Johannes Roth, Fons A. J. van de Loo, Marije I. Koenders, Louis Casteilla, Peter M. van der Kraan, Martijn H. J. van den Bosch, Peter L. E. M. van Lent
IL-1β-Mediated Activation of Adipose-Derived Mesenchymal Stromal Cells Results in PMN Reallocation and Enhanced Phagocytosis: A Possible Mechanism for the Reduction of Osteoarthritis Pathology
published pages: , ISSN: 1664-3224, DOI: 10.3389/fimmu.2019.01075
Frontiers in Immunology 10 2020-02-26
2019 Cristina Manferdini, Francesca Paolella, Elena Gabusi, Luca Cattini, Markus Rojewski, Hubert Schrezenmeier, Olga Addimanda, Riccardo Meliconi, Gina Lisignoli
Osteoarthritic Milieu Affects Adipose‐Derived Mesenchymal Stromal Cells
published pages: , ISSN: 0736-0266, DOI: 10.1002/jor.24446
Journal of Orthopaedic Research 2020-02-26
2018 Stella Cosenza, Karine Toupet, Marie Maumus, Patricia Luz-Crawford, Olivier Blanc-Brude, Christian Jorgensen, Danièle Noël
Mesenchymal stem cells-derived exosomes are more immunosuppressive than microparticles in inflammatory arthritis
published pages: 1399-1410, ISSN: 1838-7640, DOI: 10.7150/thno.21072
Theranostics 8/5 2020-02-26
2017 Schrezenmeier, Hubert
Jahrestagung der Deutschen, Österreichischen und Schweizerischen Gesellschaften für Hämatologie und Medizinische Onkologie, Stuttgart, 29. September-3. Oktober 2017: Abstracts
published pages: 1-308, ISSN: 2296-5270, DOI: 10.1159/000479566
Oncology Research and Treatment 40/3 2020-02-26
2017 Schrezenmeier, Hubert
50. Jahrestagung der Deutschen Gesellschaft für Transfusionsmedizin und Immunhämatologie (DGTI), Köln, 24.-27. Oktober 2017, Abstracts
published pages: 1-94, ISSN: 1660-3796, DOI: 10.1159/000481444
Transfusion Medicine and Hemotherapy 44/1 2020-02-26
2017 Schrezenmeier, Hubert
50. Jahrestagung der Deutschen Gesellschaft für Transfusionsmedizin und Immunhämatologie (DGTI), Köln, 24.-27. Oktober 2017, Abstracts
published pages: 1-94, ISSN: 1660-3796, DOI: 10.1159/000481444
Transfusion Medicine and Hemotherapy 44/1 2020-02-26
2016 M. H. van den Bosch, A. B. Blom, R. F. Schelbergen, M. I. Koenders, F. A. van de Loo, W. B. van den Berg, T. Vogl, J. Roth, P. M. van der Kraan, P. L. van Lent
Alarmin S100A9 Induces Proinflammatory and Catabolic Effects Predominantly in the M1 Macrophages of Human Osteoarthritic Synovium
published pages: 1874-1884, ISSN: 0315-162X, DOI: 10.3899/jrheum.160270
The Journal of Rheumatology 43/10 2020-02-26
2017 Marie Maumus, Cristina Manferdini, Karine Toupet, Paul Chuchana, Louis Casteilla, Mélanie Gachet, Christian Jorgensen, Gina Lisignoli, Danièle Noël
Thrombospondin-1 Partly Mediates the Cartilage Protective Effect of Adipose-Derived Mesenchymal Stem Cells in Osteoarthritis
published pages: , ISSN: 1664-3224, DOI: 10.3389/fimmu.2017.01638
Frontiers in Immunology 8 2020-02-26
2017 Schrezenmeier, Hubert
Jahrestagung der Deutschen, Österreichischen und Schweizerischen Gesellschaften für Hämatologie und Medizinische Onkologie, Stuttgart, 29. September-3. Oktober 2017: Abstracts
published pages: 1-308, ISSN: 2296-5270, DOI: 10.1159/000479566
Oncology Research and Treatment 40/3 2020-02-26
2014 R.F. Schelbergen, S. van Dalen, M. ter Huurne, J. Roth, T. Vogl, D. Noël, C. Jorgensen, W.B. van den Berg, F.A. van de Loo, A.B. Blom, P.L.E.M. van Lent
Treatment efficacy of adipose-derived stem cells in experimental osteoarthritis is driven by high synovial activation and reflected by S100A8/A9 serum levels
published pages: 1158-1166, ISSN: 1063-4584, DOI: 10.1016/j.joca.2014.05.022
Osteoarthritis and Cartilage 22/8 2020-02-26
2016 Yves-Marie Pers, Lars Rackwitz, Rosanna Ferreira, Oliver Pullig, Christophe Delfour, Frank Barry, Luc Sensebe, Louis Casteilla, Sandrine Fleury, Philippe Bourin, Danièle Noël, François Canovas, Catherine Cyteval, Gina Lisignoli, Joachim Schrauth, Daniel Haddad, Sophie Domergue, Ulrich Noeth, Christian Jorgensen
Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial
published pages: 847-856, ISSN: 2157-6564, DOI: 10.5966/sctm.2015-0245
STEM CELLS Translational Medicine 5/7 2020-02-26
2017 Stella Cosenza, Maxime Ruiz, Marie Maumus, Christian Jorgensen, Danièle Noël
Pathogenic or Therapeutic Extracellular Vesicles in Rheumatic Diseases: Role of Mesenchymal Stem Cell-Derived Vesicles
published pages: 889, ISSN: 1422-0067, DOI: 10.3390/ijms18040889
International Journal of Molecular Sciences 18/12 2020-02-26
2016 Cattini, Luca; Silvestri, Ylenia; Gambari, Laura; Filardo, Giuseppe; Paolella, Francesca; Gabusi, Elena; Fleury-Cappellesso, Sandrine; Manferdini, Cristina; Lisignoli, Gina
From osteoarthritic synovium to synovial-derived cells characterization: synovial macrophages are key effector cells
published pages: , ISSN: 1478-6362, DOI: 10.1186/s13075-016-0983-4
Arthritis Research & Therapy 1 2020-02-26
2015 Rita Vicente, Danièle Noël, Yves-Marie Pers, Florence Apparailly, Christian Jorgensen
Deregulation and therapeutic potential of microRNAs in arthritic diseases
published pages: 211-220, ISSN: 1759-4790, DOI: 10.1038/nrrheum.2015.162
Nature Reviews Rheumatology 12/4 2020-02-26
2017 C. Manferdini, F. Paolella, E. Gabusi, L. Gambari, A. Piacentini, G. Filardo, S. Fleury-Cappellesso, A. Barbero, M. Murphy, G. Lisignoli
Adipose stromal cells mediated switching of the pro-inflammatory profile of M1-like macrophages is facilitated by PGE2: in vitro evaluation
published pages: 1161-1171, ISSN: 1063-4584, DOI: 10.1016/j.joca.2017.01.011
Osteoarthritis and Cartilage 25/7 2020-02-26
2016 Claire Bony, Mailys Cren, Sophie Domergue, Karine Toupet, Christian Jorgensen, Danièle Noël
Adipose Mesenchymal Stem Cells Isolated after Manual or Water-jet-Assisted Liposuction Display Similar Properties
published pages: , ISSN: 1664-3224, DOI: 10.3389/fimmu.2015.00655
Frontiers in Immunology 6 2020-02-26
2015 Y.-M. Pers, M. Ruiz, D. Noël, C. Jorgensen
Mesenchymal stem cells for the management of inflammation in osteoarthritis: state of the art and perspectives
published pages: 2027-2035, ISSN: 1063-4584, DOI: 10.1016/j.joca.2015.07.004
Osteoarthritis and Cartilage 23/11 2020-02-26
2016 Claire Bony, Mailys Cren, Sophie Domergue, Karine Toupet, Christian Jorgensen, Danièle Noël
Adipose Mesenchymal Stem Cells Isolated after Manual or Water-jet-Assisted Liposuction Display Similar Properties
published pages: , ISSN: 1664-3224, DOI: 10.3389/fimmu.2015.00655
Frontiers in Immunology 6 2020-02-26
2015 Maxime Ruiz, Stella Cosenza, Marie Maumus, Christian Jorgensen, Danièle Noël
Therapeutic application of mesenchymal stem cells in osteoarthritis
published pages: 33-42, ISSN: 1471-2598, DOI: 10.1517/14712598.2016.1093108
Expert Opinion on Biological Therapy 16/1 2020-02-26

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