CORDIS
EU research results

CORDIS

English EN
ORTHOpedic randomized clinical trial with expanded bone marrow MSC and bioceramics versus autograft in long bone nonUNIONs

ORTHOpedic randomized clinical trial with expanded bone marrow MSC and bioceramics versus autograft in long bone nonUNIONs

Objective

Current orthopaedic treatments permit spontaneous bone regeneration to unite and heal 90% bone injuries. Non-union associates pain and disability, often requiring biological enhancement. Regenerative medicine research suggests to the general public that alternative treatments based on advanced therapy medicinal products (ATMP) are already available. However, early clinical trials only explore its potential benefit. Underreported results and absence of early trial confirmation in adequately powered prospective randomized clinical trials (RCT) indicate that evidence is not available to transfer any technique into routine clinical application.
This ORTHOUNION Project was developed from FP7-Project (REBORNE). Its results confirmed 92% bone healing rate (Gómez-Barrena et al, 2016 submitted manuscript) with an autologous ATMP of GMP expanded bone marrow derived human MSC in non-unions, where the reported bone healing rate after surgery with standard bone autograft is 74%. Any further development requires adequately powered prospective RCTs. This will be the main aim of ORTHOUNION: to assess clinically relevant efficacy of an autologous ATMP with GMP multicentric production in a well-designed, randomized, controlled, three-arm clinical trial under GCP, versus bone autograft, gold-standard in fracture non-unions. A non-inferiority analysis will evaluate if cell dose can be lowered. ATMP has been authorized by the National Competent Authorities of the participating countries in 3 previous trials (REBORNE) and will be monitored by ECRIN-ERIC to ensure quality and credibility of RCT results.
Secondary aims include innovative strategies to increase manufacturing capacity and lower costs to pave translation into routine clinical treatments, biomaterial refinement to facilitate surgery, personalized medicine supportive instruments for patient selection and monitoring, and health economic evaluation. Results in this project may help define the future of bone regenerative medicin

Coordinator

UNIVERSIDAD AUTONOMA DE MADRID

Address

Calle Einstein 3 Ciudad Univ Cantoblanco Rectorado
28049 Madrid

Spain

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 824 210,01

Participants (10)

Sort alphabetically

Sort by EU Contribution

Expand all

SERVICIO MADRILENO DE SALUD

Spain

EU Contribution

€ 1 352 056

ETABLISSEMENT FRANCAIS DU SANG

France

EU Contribution

€ 394 743,25

UNIVERSITAET ULM

Germany

EU Contribution

€ 998 476,63

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

France

EU Contribution

€ 221 230

ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK

France

EU Contribution

€ 573 694

CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE TOURS

France

EU Contribution

€ 193 125

ISTITUTO ORTOPEDICO RIZZOLI

Italy

EU Contribution

€ 449 923,48

UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA

Italy

EU Contribution

€ 293 680

FONDAZIONE IRCCS CA' GRANDA - OSPEDALE MAGGIORE POLICLINICO

Italy

EU Contribution

€ 420 950

BIOMATLANTE

France

EU Contribution

€ 277 062,50

Project information

Grant agreement ID: 733288

Status

Ongoing project

  • Start date

    1 January 2017

  • End date

    31 December 2021

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 5 999 150,87

  • EU contribution

    € 5 999 150,87

Coordinated by:

UNIVERSIDAD AUTONOMA DE MADRID

Spain