Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule Following Resection of a Non Melanoma Skin Cancer- a Phase I Clinical Trial.

Conditions
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Skin Carcinoma

Intervention / Treatment
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* Biological: engineered nasal cartilage graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: size of defect: ≥50% of alar subunit Extent of defect: 2 layer defect: skin and fibro-cartilaginous tissues Exclusion Criteria: Defect extent:3 layers defect, including mucosa defect extent: 1 layer defect pregnancy immunodeficiency HIV Hepatitis B, C Allergy to porcine collagen, penicillin or streptomycin Chronic treatment with steroids or growth factors (immunomodulatory drugs)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: engineered nasal cartilage graft<br>Biological intervention: autologous nasal chondrocytes expanded in vitro and cultured in a collagen Type I/III scaffold | Biological: engineered nasal cartilage graft<br>* implantation of engineered nasal cartilage grafts in the alar lobule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of treatment | Functional testing of breathing Questionnaire of evaluation | 12 months post reconstruction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal cartilage diseases