Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule Following Resection of a Non Melanoma Skin Cancer- a Phase I Clinical Trial.
Skin cancer is the most prevalent reason for surgically creating a multilayer defect,
consisting of skin and cartilage, of the alar lobule of the nose. In reconstruction of these
defects, a combination of local flaps and autologous cartilage, typically harvested from the
nasal septum or the ear, is used to restore the stability, function and proper 3D shape of
the alar lobule. Harvesting autologous cartilage from the ear has been associated with a
number of complications that could be overcome by the use of engineered cartilage graft
generated in vitro with autologous cells.
This study is a phase I, prospective, uncontrolled, investigator initiated clinical trial
involving 5 patients, with the objective of demonstrating safety and feasibility in the use
of engineered nasal cartilage grafts. The specific surgical target of the trial is the
reconstruction of a two layer defect of the alar lobule using a tissue engineered nasal
cartilage graft and a local flap, following resection of a non melanoma skin cancer.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
safety: post operative complications should not be at higher rate than gold standard operative procedure.
Post operative complications could be: infections, bleeding, formation of scar tissue, asymmetry of the nostril to the opposite side
12 months post reconstruction
Ivan Martin, Prof
University Hospital, Basel, Switzerland