Engineered Tissue Repair of Bronchopleural Fistula (ENTRUST)
Research type
Research Study
Full title
Phase I/II open-label study to assess the safety and efficacy of a novel tissue engineered airway product, consisting of expanded autologous Bone Marrow (BM) derived Mesenchymal Stromal Cells (MSC) seeded on to a decellularised allogeneic patch of an airway scaffold in subjects with clinically significant bronchopleural fistula.
IRAS ID
278732
Contact name
Steve Bloor
Contact email
Sponsor organisation
Videregen Limited
Eudract number
2019-004939-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
This study is currently paused. This is a phase I/II open-label study, which is being done to investigate the safety and potential benefit of implanting a Tissue Engineered (TE) tracheal patch for subjects with Bronchopleural Fistula (BPF). This study is an uncontrolled pilot in 5 subjects with a total duration of 41 months from pre-screening activities to last subject follow-up. An independent data safety monitoring board (DSMB) will meet after each of the first 3 subjects have reached the 3-month timepoint to review cumulative safety data and determine continuity of the study. The DSMB can stop the study should there be any safety concerns from their review, or else allow the remaining subjects to be implanted with the TE patch. Subjects who undergo implantation will be hospitalised for up to 35 days after surgery and will be monitored closely by the highly skilled medical team selected for this study. This is a novel therapy, there are no documented risks impacting subject safety. Possible related risks have been identified and documented in a non-clinical study conducted for the purpose of this clinical trial.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
20/SC/0130
Date of REC Opinion
2 Jun 2020
REC opinion
Further Information Favourable Opinion