Tracheal Stenosis Clinical Trial
Official 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 Decellularised Tracheal Scaffold With Seeded Autologous Mesenchymal Cells in Subjects With Severe Tracheal Stenosis or Malacia
This is a phase I study to evaluate the safety, efficacy and tolerability of a novel tracheal replacement therapy using cadaveric de-cellularised tracheal scaffold and patients' own mesenchymal cells isolated from a sample of their bone marrow in patients' who suffer from severe tracheal malacia or stenosis.
This is a phase I study to evaluate the safety, tolerability and potential efficacy of a
novel tracheal replacement therapy using a cadaveric tracheal scaffold and patients own
mesenchymal cells isolated from a sample of the patients own bone marrow. The study is aimed
at treating patients who suffer from severe tracheal stenosis or malacia and for whom
conventional therapies are no longer adequate. A total of 4 patients will be treated during
the course of this study.
A hospital multi disciplinary team will review the medical history and available treatment
options for all potential patients and recommend whether they are suitable for the study.
Once patients are approved they will enter an 8 week screening period. During this period
bone marrow from the patient will be harvested and the manufacturing of the final graft
tissue will start. The manufacturing facility will use a cadaveric donated decellularised
tracheal scaffold (supplied by the NHS blood and transplant body) and the patients own cells
to make the final investigational product (graft).
The product will be surgically grafted into the patient in place of the damaged tracheal
section. The graft will be supported by a stent for the first 6 months with replacements of
this stent occurring at week 8 and week 16 post-surgical procedure. Hospitalization for a
number of days will be required during this replacement steps. The patient will be followed
frequently post surgery to capture any safety and efficacy measures. Long term follow up will
continue up to 5 years post surgery.
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