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ORTHO-ALLO-UNION

Financiado

Cerrado

ORTHOpaedic treatment with ALLOgenic combined ATMP in long bone fracture delayed...

ORTHOpaedic treatment with ALLOgenic combined ATMP in long bone fracture delayed UNION and non union ORTHO ALLO UNION . 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... ver más

30/11/2028

SERMAS

10M€

Presupuesto del proyecto: 10M€

Líder del proyecto

SERVICIO MADRILENO DE SALUD No se ha especificado una descripción o un objeto social para esta compañía.

Fecha límite participación Sin fecha límite de participación.

Ver 19 Participantes

Financiación concedida El organismo HORIZON EUROPE notifico la concesión del proyecto el día 2023-11-28

HORIZON-HLTH-2023-TOOL-05-01: Clinical trials of combined Advance... Expected Outcome:This topic aims at supporting activities that are enabling or contributing to one o...

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Características del participante

Este proyecto no cuenta con búsquedas de partenariado abiertas en este momento.

Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

19 Participantes

SERMAS

2.85M€ | Lider

LMU MUENCHEN

231.25K€ | Participante

UAM

477.25K€ | Participante

UNIMORE

618.44K€ | Participante

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Duración del proyecto: 60 meses Fecha Inicio: 2023-11-28
Fecha Fin: 2028-11-30

Líder del proyecto

SERVICIO MADRILENO DE SALUD No se ha especificado una descripción o un objeto social para esta compañía.

Presupuesto del proyecto 10M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto 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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