The School of Medicine at the Universidad Autónoma De Madrid hosted the Kick-off meeting for the ORTHO-ALLO-UNION European research project with advanced therapies, led by the Puerta de Hierro Majadahonda and La Paz public hospitals under the coordination of the Madrid Health Service (SERMAS). Over the next five years, up to 18 leading clinician and researcher partners from Germany, France, Italy and Spain, together with our consulting firm PONS IP, will collaborate to develop an effective, safe and accessible solution for patients suffering from unhealed bone fractures and obtain an “advanced therapy medicinal product” to improve bone regeneration.
Although only a small proportion of long bone fractures do not eventually heal, approximately 5%, this is a major problem that requires repeated procedures and involves years of patient incapacity. The treatments used to date include bone autografts, autologous mesenchymal cells or other complex interventions that have an enormous economic and health impact for developed countries.
Funded by the EU within the framework of Horizon Europe and with an estimated budget of nearly 10 million euros, the project seeks to develop a novel combined tissue engineering treatment that provides an effective, safe and accessible solution for patients suffering from unhealed bone fractures and obtain an “advanced therapy medicinal product” to improve bone regeneration. Thus, ORTHO-ALLO-UNION will develop a universal therapy for fractures with delayed or failed healing with the aim that patients and surgeons have easy and broad access to combined allogeneic cell therapy, through the creation of a master cell bank for extensive allogeneic production with donor selection criteria of bone formation potential.
Through leadership in tasks related to, among others, the dissemination, communication and exploitation plan, and the drawing up of the Data Management Plan, our Innovation Project Manager of the Technological Innovation Consulting Area at PONS IP, Isabel Marco, mentioned after the kick-off meeting the “special pride” that comes with being part of this “extraordinary project” as a member of a consortium in which world-renowned institutions and leading clinicians and researchers participate in the challenges of bone regeneration. In the future, as Marco indicated, the development of a clinical network is envisaged in order to start a clinical trial with 9 large Orthopaedic Surgery and Traumatology hospital departments at university hospitals throughout Europe.
The initiative of the La Paz and Puerta de Hierro de Majadahonda hospitals is part of the Regional Strategy for Advanced Therapies, a pioneer at the national level and implemented by the Community of Madrid in 2018. One of its strategic objectives is to promote R&D&I in this area. Furthermore, the research was chosen by the European Union to be funded with 10 million euros in the Horizon Europe competitive call.
Under the coordination of the Madrid Health Service (SERMAS), Universitaet Ulm (UULM), Fondazione Irccs Ca’ Granda – Ospedale Maggiore Policlinico, Etablissement Francais Du Sang (EFS), Universita Degli Studi Di Modena E Reggio Emilia – Unimore, Institut National de la Sante Et De La Recherche Medicale, Universidad Autónoma De Madrid (UAM), Assistance Publique Hopitaux De Paris, Ludwig-Maximilians-Universitaet Muenchen (LMU Muenchen), Istituto Ortopedico Rizzoli (IOR), Fondazione Policlinico Universitario Campus Bio Medico, Biomatlante, Ecrin European Clinical Research Infrastructure Network (ECRIN), and Centre Hospitalier Regional Universitaire De Tours – Chru Bretonneau Tours participate in the project together with PONS IP.
