The “ORTHOpaedic randomized clinical trial with expanded bone marrow MSC and bioceramics versus autograft in long bone nonUNIONs” project (ORTHOUNION) is funded by the European Commission H2020 programme within the topic SCI-PM-11-2016-17: Clinical research on regenerative medicine, under Grant Agreement #733288. It will be developed during 5 years, from January 2017 to December 2021.
The ORTHOUNION Consortium is in charge of completing the project. It is integrated by 11 partners and 3 linked third parties from France, Germany, Italy and Spain, under the coordination of the Autonomous University of Madrid. Those partners have established a clinical network, including 20 clinical centres and 5 cell production units in Spain, France, Italy and Germany, to complete the planned clinical trial.
ORTHOUNION involves partners that are used to work together and that have already achieved collectively excellent results through the FP7-REBORNE project. The Consortium has been assembled to meet the required specific competencies: a combination of stem cell and regenerative medicine experts with expert orthopaedic surgeons and clinicians .
ORTHOUNION is one natural progression of the FP7 REBORNE project (http://cordis.europa.eu/result/rcn/176854_es.html) (Regenerating Bone defects using New biomedical Engineering approaches, FP7 HEALTH-2009-1.4-2, Grant Agreement 241879) that developed, from 2010 to 2015, the basic and early clinical research on bone healing related to long bone non-unions (ORTHO-1 clinical trial) and bone osteonecrosis (ORTHO-2 and ORTHO-3 clinical trials).
The global aim of ORTHOUNION is to overcome the major hurdle to complete the translation to clinical application: obtaining evidence.
The primary aim is to prove efficacy of two doses of expanded Bone Marrow-Mesenchymal Stem Cells + Biomaterial in long bone non-unions, developed after bone fracture, in a comparative, multicentre, multinational, randomized clinical trial versus the accepted standard therapy for non-unions.
The secondary aim of the project is to define the exploitation strategies based on real economic evaluations.