CORDIS
EU research results

CORDIS

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

Project information

Grant agreement ID: 643809

Status

Closed project

  • Start date

    1 January 2015

  • End date

    31 December 2019

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 5 999 000

  • EU contribution

    € 5 999 000

Coordinated by:

NATIONAL UNIVERSITY OF IRELAND GALWAY

Ireland

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.

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

ETABLISSEMENT FRANCAIS DU SANG

France

EU Contribution

€ 890 430

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

France

EU Contribution

€ 157 600

ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK

France

EU Contribution

€ 185 712

HUMAN MED AG

Germany

EU Contribution

€ 73 875

STICHTING KATHOLIEKE UNIVERSITEIT

Netherlands

EU Contribution

€ 354 600

SPORTS SURGERY CLINIC LIMITED

Ireland

EU Contribution

€ 83 486

UNIVERSITA DEGLI STUDI DI PADOVA

Italy

EU Contribution

€ 177 300

EVANGELISCHES WALDKRANKENHAUS SPANDAU KRANKENHAUSBETRIEBS GGMBH

Germany

EU Contribution

€ 246 250

PINTAIL LTD

Ireland

EU Contribution

€ 193 552,50

CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS

France

EU Contribution

€ 165 207,50

UNIVERSITAET ULM

Germany

EU Contribution

€ 903 738

CENTRE HOSPITALIER UNIVERSITAIRE MONTPELLIER

France

EU Contribution

€ 434 976

Cambridge University Hospitals NHS Foundation Trust

United Kingdom

EU Contribution

€ 187 150

Aries srl

Italy

EU Contribution

€ 60 825

ASSISTANCE PUBLIQUE HOPITAUX DE PARIS

France

EU Contribution

€ 217 300

CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE

France

EU Contribution

€ 177 300

CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE

France

EU Contribution

€ 43 761,91

Project information

Grant agreement ID: 643809

Status

Closed project

  • Start date

    1 January 2015

  • End date

    31 December 2019

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 5 999 000

  • EU contribution

    € 5 999 000

Coordinated by:

NATIONAL UNIVERSITY OF IRELAND GALWAY

Ireland