Project description
Universal therapy for delayed healing in fractures
While only 5 % of long bone fractures result in non-union, this still poses a significant challenge due to the sheer number of new fractures each year and the increasing complexity of fractures, which heightens the risk of non-consolidation. Treatment options include bone autografts, autologous mesenchymal cells, or other interventions. The EU-funded ORTHO-ALLO-UNION project aims to develop a universal therapy for fractures that have experienced delayed or failed healing. Rather than reserving advanced therapy medicinal products (ATMPs) solely as a last resort for established non-union fractures, the project proposes that patients should receive combined ATMP treatment as soon as the need for reoperation is identified. This approach is in line with patients’ needs and aligns with widespread practice in the EU.
Objective
Bone fracture with delay or failure to heal is a condition with huge health impact. Although only a small proportion of long bone fractures evolve to non-union (5%), it is a first magnitude problem due to the number of new annual fractures and increasing incidence of complex fractures with high risk of non-consolidation, need for repeated procedures and years of patient disability. Bone autografts, autologous mesenchymal cells, or other complex interventions are used in this setting.
The aim of this project is the development of a universal therapy for fractures with delay or failure to heal, aiming to a simple and wide access to allogenic cell therapy combined with biomaterial, in a broad number of patients. Rather than considering ATMP only as a last solution in established non-union fractures, this project advocates that the indication should be moved to an earlier timepoint. Patients will be treated with the combined ATMP as soon as the need for reoperation is identified due to delayed healing, with or without an added infectious component, to avoid long-term suffering for patients and their relatives, and prevent progression to more severe non-unions, with heavy personal, social and economic costs. This approach is aligned with the real needs of patients and better fits with the usual practice in the EU, where reoperations are performed at 6 months or before, in an attempt to accelerate bone healing and avoid complications.
The project will establish a master cell bank for a wide allogenic production with donors selection criteria of bone formation potential. Necessary preclinical and clinical information to support the EU approval of a specific combined ATMP will be obtained. Open access to scientific and regulatory information will be available for other EU medical device companies and cell therapy producers, so in addition to direct clinical benefit to patients and healthcare providers, other developers of combined ATMP products will get benefit.
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HORIZON-RIA - HORIZON Research and Innovation ActionsCoordinator
28046 MADRID
Spain
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Participants (18)
Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
28222 Majadahonda
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
28046 Madrid
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89081 Ulm
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20122 Milano
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93210 La Plaine Saint Denis
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41121 Modena
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75654 Paris
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28049 Madrid
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75012 Paris
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80539 MUNCHEN
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
81377 Munchen
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40136 Bologna
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00128 Roma
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44360 Vigneux De Bretagne
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
28010 MADRID
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75014 Paris
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
29590 MALAGA
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37044 Tours Cedex 9
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