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Autologous Stem Cell Seeded Tissue Engineered Trachea

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.

Coordinator

VIDEREGEN LIMITED

Address

Innovation Centre 1, Liverpool Science Park, 131 M Ant
L3 5tf Liverpool

United Kingdom

Activity type

Private for-profit entities (excluding Higher or Secondary Education Establishments)

EU Contribution

€ 1 563 340,80

Participants (13)

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EURAM LIMITED

United Kingdom

EU Contribution

€ 65 496,20

CELL THERAPY CATAPULT LIMITED

United Kingdom

EU Contribution

€ 281 681

TMC PHARMA SERVICES LIMITED

United Kingdom

EU Contribution

€ 1 127 146

NHS BLOOD AND TRANSPLANT

United Kingdom

EU Contribution

€ 535 250

KLINIKUM RECHTS DER ISAR DER TECHNISCHEN UNIVERSITAT MUNCHEN

Germany

EU Contribution

€ 903 250

UNIVERSITY COLLEGE LONDON

United Kingdom

EU Contribution

€ 455 118

UNIVERSITY COLLEGE LONDON HOSPITALSNHS FOUNDATION TRUST

United Kingdom

EU Contribution

€ 669 578

UNIVERSITA DEGLI STUDI DI BRESCIA

Italy

EU Contribution

€ 346 266

MEDIZINISCHE UNIVERSITAET WIEN

Austria

EU Contribution

€ 2 546

INSTYTUT GRUZLICY I CHOROB PLUC

Poland

EU Contribution

€ 365 000

THE UNIVERSITY OF MANCHESTER

United Kingdom

EU Contribution

€ 30 700

MANCHESTER UNIVERSITY NHS FOUNDATION TRUST

United Kingdom

EU Contribution

€ 483 512

UNIVERSITY HOSPITAL OF SOUTH MANCHESTER NHS FOUNDATION TRUST

United Kingdom

Project information

Grant agreement ID: 681027

Status

Grant agreement terminated

  • Start date

    1 January 2016

  • End date

    31 December 2019

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 6 828 887,50

  • EU contribution

    € 6 828 884

Coordinated by:

VIDEREGEN LIMITED

United Kingdom