ORTHOunion

ORTHOpedic randomized clinical trial with expanded bone marrow MSC and bioceramics versus

Abstract

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 medicine

Project details

Unibo Team Leader: Francesco Paolucci

Unibo involved Department/s:
Dipartimento di Sociologia e Diritto dell'Economia

Coordinator:
Universidad Autonoma de Madrid(Spain)

Other Participants:
Servicio Madrileǹo De Salud (Spain)
Etablissement Français du Sang (France)
Università  degli Studi di MODENA e REGGIO EMILIA (Italy)
Biomatlante SA (France)
Istituto Ortopedico Rizzoli (Italy)
Universitaet Ulm (Germany)
Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico Di Milano (Italy)
Ecrin-European Clinical Research Infrastructure Network (France)
Hopital Universtaire De Tours (France)
Inserm (France)

Third parties:
ALMA MATER STUDIORUM - Università di Bologna (Italy)

Total Eu Contribution: Euro (EUR) 5.999.150,87
Project Duration in months: 60
Start Date: 01/01/2017
End Date: 31/12/2021

Cordis webpage

Good health and well-being This project contributes to the achievement of the Sustainable Development Goals of the UN 2030 Agenda.

UE flag This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 733288