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Phase I Tracheal replacement using tracheal scaffold and MSC’s

Full title A Phase I open-label study to assess the safety, tolerability and potential efficacy of a novel tracheal replacement consisting of a tissue engineered de-celluarised tracheal scaffold with seeded autologous mesenchymal stem cells in subjects with severe tracheal stenosis or malacia
Research type Research study
IRAS ID 168851
Contact Name Gareth Wright
Contact Email gareth.wright@ct.catapult.org.uk
Sponsor organisation
Eudract number 2015-002108-10
ISRCTN number
Clinicaltrials.gov identifier
Additional reference number fields 2015-002108-10, EUDRACT Number
Research summary This is a phase I study to assess the safety, tolerability and potential efficacy of a novel tissue engineered tracheal transplant in patients with tracheal stenosis (narrowing of the windpipe) and malacia (weakness or floppiness of the windpipe). Patients with tracheal stenosis/malacia require multiple surgeries, laser and stenting procedures to keep the windpipe open and functional with outcomes which are generally poor with high morbidity and reduced quality of life. The damaged and/or diseased tracheal section will be removed from the patient and a replacement trachea graft surgically implanted. The replacement graft will comprise a human decellularised tracheal scaffold obtained from a cadaveric donor and seeded with the patients own mesenchymal stem cells harvested from a bone marrow aspirate. The graft will be supported by stenting for the first 6 months with stent replacement at 8 and 16 weeks. The graft will also be protected by an omental or muscle wrap obtained from the patient at the time of initial surgery and Glyaderm (artificial skin). The patient will be a hospital inpatient for approximately 3 weeks post initial graft surgery followed by in-patient stays during subsequent stent removal and replacement. Participants will be followed up and monitored for up to 5 years.
REC Name South Central - Oxford A Research Ethics Committee
REC Reference 15/SC/0629
REC Opinion

Further Information Favourable Opinion

Further Information Favourable Opinion

Date of REC Opinion 7 January 2016