Phase I Tracheal replacement using tracheal scaffold and MSC's

• Research type

  Research Study

• 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

• IRAS ID

  168851

• Contact name

  Gareth Wright

• Contact email

  gareth.wright@ct.catapult.org.uk

• Eudract number

  2015-002108-10

• Clinicaltrials.gov Identifier

  2015-002108-10, EUDRACT Number

• Duration of Study in the UK

  6 years, 0 months, 1 days

• 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

• Date of REC Opinion

  7 Jan 2016

• REC opinion

  Further Information Favourable Opinion