000182613 001__ 182613
000182613 005__ 20230214173400.0
000182613 0247_ $$2CORDIS$$aG:(EU-Grant)681027$$d681027
000182613 0247_ $$2CORDIS$$aG:(EU-Call)H2020-PHC-2015-single-stage_RTD$$dH2020-PHC-2015-single-stage_RTD
000182613 0247_ $$2originalID$$acorda__h2020::681027
000182613 035__ $$aG:(EU-Grant)681027
000182613 150__ $$aAutologous Stem Cell Seeded Tissue Engineered Trachea$$y2016-01-01 - 2019-12-31
000182613 371__ $$aTMC PHARMA SERVICES LIMITED$$bTMC Pharma Services Ltd$$dUnited Kingdom$$ehttp://www.tmcpharma.com$$vCORDIS
000182613 371__ $$aVIDEREGEN LIMITED$$dUnited Kingdom$$ehttp://www.videregen.com$$vCORDIS
000182613 371__ $$aMANCHESTER UNIVERSITY NHS FOUNDATION TRUST$$dUnited Kingdom$$ehttp://www.mft.nhs.uk$$vCORDIS
000182613 371__ $$aUniversity of London - University College London$$bUCL$$dUnited Kingdom$$ehttp://www.ucl.ac.uk/$$vCORDIS
000182613 371__ $$aUNIVERSITY HOSPITAL OF SOUTH MANCHESTER NHS FOUNDATION TRUST$$bUHSM$$dUnited Kingdom$$ehttp://www.uhsm.nhs.uk$$vCORDIS
000182613 371__ $$aInstytut Gruźlicy i Chorób Płuc$$bInstytut Gruźlicy i Chorób Płuc$$dPoland$$ehttp://www.igichp.edu.pl/$$vCORDIS
000182613 371__ $$aCell Therapy Catapult$$bCell Therapy Catapult$$dUnited Kingdom$$ehttps://www.catapult.org.uk$$vCORDIS
000182613 371__ $$aNHS Blood and Transplant$$bNHSBT$$dUnited Kingdom$$ehttp://www.nhsbt.nhs.uk/$$vCORDIS
000182613 371__ $$aEURAM LIMITED$$dUnited Kingdom$$ehttp://www.euram.ltd.uk$$vCORDIS
000182613 371__ $$aUniversity College London Hospitals NHS Foundation Trust$$bUCLH$$dUnited Kingdom$$ehttps://www.uclh.nhs.uk/Pages/home.aspx$$vCORDIS
000182613 371__ $$aUniversity of Brescia$$bUniversity of Brescia$$dItaly$$ehttp://www.unibs.it/$$vCORDIS
000182613 371__ $$aMEDIZINISCHE UNIVERSITAET WIEN$$dAustria$$ehttp://www.meduniwien.ac.at$$vCORDIS
000182613 371__ $$aKLINIKUM RECHTS DER ISAR DER TECHNISCHEN UNIVERSITAT MUNCHEN$$bTUM-MED$$dGermany$$ehttp://www.med.tu.muenchen.de$$vCORDIS
000182613 371__ $$aUniversity of Manchester$$bUniversity of Manchester$$dUnited Kingdom$$ehttp://www.manchester.ac.uk/$$vCORDIS
000182613 372__ $$aH2020-PHC-2015-single-stage_RTD$$s2016-01-01$$t2019-12-31
000182613 450__ $$aTETRA$$wd$$y2016-01-01 - 2019-12-31
000182613 5101_ $$0I:(DE-588b)5098525-5$$2CORDIS$$aEuropean Union
000182613 680__ $$aCLINICAL 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.
000182613 909CO $$ooai:juser.fz-juelich.de:278196$$pauthority$$pauthority:GRANT
000182613 909CO $$ooai:juser.fz-juelich.de:278196
000182613 970__ $$aoai:dnet:corda__h2020::9dde20d4da3f2774dfdc266831006fb3
000182613 980__ $$aG
000182613 980__ $$aCORDIS
000182613 980__ $$aAUTHORITY