Hola,
¿eres nuevo aquí?

Regístrate gratis y conecta tu empresa con financiación pública, partners y proyectos.

Tengo cuenta

Regístrate

Ver video

ORTHOUNION

Financiado

Cerrado

ORTHOpedic randomized clinical trial with expanded bone marrow MSC and biocerami...

ORTHOpedic randomized clinical trial with expanded bone marrow MSC and bioceramics versus autograft in long bone nonUNIONs 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... ver más

30/06/2022

UAM

6M€

Presupuesto del proyecto: 6M€

Líder del proyecto

UNIVERSIDAD AUTÓNOMA DE MADRID No se ha especificado una descripción o un objeto social para esta compañía.

Total investigadores 3185

Fecha límite participación Sin fecha límite de participación.

Ver 18 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2022-06-30

SC1-PM-11-2016-2017: Clinical research on regenerative m...

I+D

Cerrada hace 8 años

0% 100%

Información adicional privada

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

18 Participantes

UAM

824.21K€ | Lider

BUNT PLANET

258.55K€ | Participante

UKLFR

97.29K€ | Participante

UNIMORE

293.68K€ | Participante

Conecta tu I+D

¿Tienes un proyecto y buscas un partner? Gracias a nuestro motor inteligente podemos recomendarte los mejores socios y ponerte en contacto con ellos. Te lo explicamos en este video

Proyectos interesantes

ORTHO-ALLO-UNION ORTHOpaedic treatment with ALLOgenic combined ATMP in long b... 10M€ Cerrado

SKELETAL STEM CELLS Role of Skeletal Stem Cells in Bone Repair 100K€ Cerrado

MAXIBONE Personalised maxillofacial bone regeneration 6M€ Cerrado

ADIPOA2 Clinical trial of autologous adipose derived mesenchymal str... 6M€ Cerrado

kiNESIS NovEl Strategies for treatIng tendon to bone injurieS kiNE... 150K€ Cerrado

HEALIKICK A modular strategy for the repair of critical sized bone fra... 5M€ Cerrado

Duración del proyecto: 66 meses Fecha Inicio: 2016-12-12
Fecha Fin: 2022-06-30

Líder del proyecto

UNIVERSIDAD AUTÓNOMA DE MADRID No se ha especificado una descripción o un objeto social para esta compañía.

Total investigadores 3185

Presupuesto del proyecto 6M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto 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 medicin

Conecta tu I+D

Entra hoy

¿Olvidé mi contraseña?

Financiación

Empresas

CTIs/Universidades

Proyectos

Investigadores