Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule
The purpose of this study is to investigate the safety and feasibility of implanting an engineered cartilage graft, obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane, in the alar lobule of patients after resection of a non melanoma skin cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule Following Resection of a Non Melanoma Skin Cancer- a Phase I Clinical Trial.|
- safety: post operative complications should not be at higher rate than gold standard operative procedure. [ Time Frame: 12 months post reconstruction ] [ Designated as safety issue: Yes ]Post operative complications could be: infections, bleeding, formation of scar tissue, asymmetry of the nostril to the opposite side
- feasibility of treatment [ Time Frame: 12 months post reconstruction ] [ Designated as safety issue: No ]Functional testing of breathing Questionnaire of evaluation
|Study Start Date:||October 2010|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: engineered nasal cartilage graft
Biological intervention: autologous nasal chondrocytes expanded in vitro and cultured in a collagen Type I/III scaffold
Biological: engineered nasal cartilage graft
implantation of engineered nasal cartilage grafts in the alar lobule
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242618
|University Hospital Basel|
|Basel, Switzerland, 4031|
|Principal Investigator:||Ivan Martin, Prof||University Hospital, Basel, Switzerland|