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Autologous Stem Cell Seeded Tissue Engineered Trachea

Objective

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.

Call for proposal

H2020-PHC-2014-2015

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Sub call

H2020-PHC-2015-single-stage_RTD

Coordinator

VIDEREGEN LIMITED
Net EU contribution
€ 1 563 340,80
Address
Innovation Centre 1, Liverpool Science Park, 131 M Ant
L3 5TF Liverpool
United Kingdom

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Region
North West (England) Merseyside Liverpool
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,17

Participants (12)

EURAM LIMITED

Participation ended

United Kingdom
Net EU contribution
€ 65 496,20
Address
Lucy Tower Street Tower House
LN1 1XW Lincoln

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
East Midlands (England) Lincolnshire Lincolnshire
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,50
CELL THERAPY CATAPULT LIMITED
United Kingdom
Net EU contribution
€ 281 681,00
Address
12th Floor Tower Wing Guy's Hospital Great Maze Pond
SE1 9RT London

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
London Inner London — East Lewisham and Southwark
Activity type
Research Organisations
Non-EU contribution
€ 0,25
TMC PHARMA SERVICES LIMITED
United Kingdom
Net EU contribution
€ 1 127 146,00
Address
Lodge Farm Barn, Elvetham Park Estate
RG27 8AS Hartley Wintney

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
South East (England) Hampshire and Isle of Wight North Hampshire
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,25
NHS BLOOD AND TRANSPLANT
United Kingdom
Net EU contribution
€ 535 250,00
Address
Oak House Reeds Crescent
WD24 4QN Watford

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Region
East of England Bedfordshire and Hertfordshire Hertfordshire
Activity type
Research Organisations
Non-EU contribution
€ 0,00
KLINIKUM RECHTS DER ISAR DER TECHNISCHEN UNIVERSITAT MUNCHEN
Germany
Net EU contribution
€ 903 250,00
Address
Ismaninger Strasse 22
81675 Muenchen

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Region
Bayern Oberbayern München, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
UNIVERSITY COLLEGE LONDON
United Kingdom
Net EU contribution
€ 455 118,00
Address
Gower Street
WC1E 6BT London

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Region
London Inner London — West Camden and City of London
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,75
UNIVERSITY COLLEGE LONDON HOSPITALSNHS FOUNDATION TRUST
United Kingdom
Net EU contribution
€ 669 578,00
Address
Euston Road 250
NW1 2PG London

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Region
London Inner London — West Camden and City of London
Activity type
Research Organisations
Non-EU contribution
€ 0,75
UNIVERSITA DEGLI STUDI DI BRESCIA
Italy
Net EU contribution
€ 346 266,00
Address
Piazza Mercato 15
25121 Brescia

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Region
Nord-Ovest Lombardia Brescia
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,25
MEDIZINISCHE UNIVERSITAET WIEN

Participation ended

Austria
Net EU contribution
€ 2 546,00
Address
Spitalgasse 23
1090 Wien

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Region
Wien Wien
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,08
INSTYTUT GRUZLICY I CHOROB PLUC
Poland
Net EU contribution
€ 365 000,00
Address
Ul. Plocka 26
01138 Warszawa

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Region
Makroregion województwo mazowieckie Warszawski stołeczny Miasto Warszawa
Activity type
Research Organisations
Non-EU contribution
€ 0,00
THE UNIVERSITY OF MANCHESTER
United Kingdom
Net EU contribution
€ 30 700,00
Address
Oxford Road
M13 9PL Manchester

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Region
North West (England) Greater Manchester Manchester
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
MANCHESTER UNIVERSITY NHS FOUNDATION TRUST
United Kingdom
Net EU contribution
€ 483 512,00
Address
Oxford Road
M13 9WL Manchester

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Region
North West (England) Greater Manchester Manchester
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,50