Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule

Phase 1

Completed

• Conditions: Skin Carcinoma
• Interventions: Biological: engineered nasal cartilage graft

• Registration Number: NCT01242618
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2010-11-16
• Study First Posted: 2010-11-17
• Primary Completion: 2013-02
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-19
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
engineered nasal cartilage graft	engineered nasal cartilage graft	Biological intervention: autologous nasal chondrocytes expanded in vitro and cultured in a collagen Type I/III scaffold

Primary Outcome Measures

Name	Time	Method
safety: post operative complications should not be at higher rate than gold standard operative procedure.	12 months post reconstruction	Post operative complications could be: infections, bleeding, formation of scar tissue, asymmetry of the nostril to the opposite side

Secondary Outcome Measures

Name	Time	Method
feasibility of treatment	12 months post reconstruction	Functional testing of breathing Questionnaire of evaluation

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland