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TETRA

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Autologous Stem Cell Seeded Tissue Engineered Trachea

CLINICAL PROBLEM AND UNMET NEED There are 11,827 patients with severe structural airway disease in Europe. Even with the current standard of care, when hospitalised this group of patients has a 22% risk of dying. Patients are cur... ver más

31/12/2019

VID

7M€

Presupuesto del proyecto: 7M€

Líder del proyecto

VIDEREGEN LIMITED No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite participación Sin fecha límite de participación.

Ver 13 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2019-12-31

PHC-15-2015: Clinical research on regenerative m...

I+D

Cerrada hace 9 años

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Información adicional privada

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

13 Participantes

VID

1.56M€ | Lider

UNIBS

346.27K€ | Participante

EURAM

65.50K€ | Participante

UNIVERSITY OF MANCHESTER

30.70K€ | Participante

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Duración del proyecto: 51 meses Fecha Inicio: 2015-09-21
Fecha Fin: 2019-12-31

Líder del proyecto

VIDEREGEN LIMITED No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 7M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto CLINICAL PROBLEM AND UNMET NEED There are 11,827 patients with severe structural airway disease in Europe. Even with the current standard of care, when hospitalised this group of patients has a 22% risk of dying. Patients are currently subjected to repeated surgical interventions (stent insertion) which have a high failure rate. Other therapeutic strategies under development include synthetic tracheal scaffolds seeded with patients own stem cells. Preliminary data show that these scaffolds are poorly integrated and are susceptible to infection. TETRA PROJECT Our SME-led project will address the limitations of standard clinical care and competitor products under development and will: - Build on our successful compassionate use experience using autologous stem cell seeded scaffold-tracheal transplants in 48 patients - Follow on from our Phase I 4 patient INSPIRE clinical trial which will improve on the clinical prototype used in compassionate use cases - Conduct a 48 patient Phase II pivotal clinical trial to provide robust, quality data with validated GMP manufacturing processes to support an accelerated route to market for commercial exploitation in this orphan indication - Prepare a dossier for MAA submission BENEFITS Our product, an ATMP, aims to eliminate the need for repeated surgical interventions of high risk and limited efficacy, reduce deaths and improve the quality of life for surviving patients. If treating 20% of the patients with severe structural airway disease, we estimate that in Europe our technology will improve the quality and length of patient lives and result in savings of €517 million per year. We plan to further develop our platform technology to generate other complex tissues/organs such as bowel and liver replacements for clinical applications which will impact the lives of tens of thousands of patient in the EU with bowel and liver diseases.

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