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Completed

NCT Number: NCT01242618

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.

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Key information

Conditions

Skin Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

engineered nasal cartilage graft

Biological

implantation of engineered nasal cartilage grafts in the alar lobule

Primary outcomes

  1. safety: post operative complications should not be at higher rate than gold standard operative procedure.

    Time frame: 12 months post reconstruction

    Post operative complications could be: infections, bleeding, formation of scar tissue, asymmetry of the nostril to the opposite side

Secondary outcomes

  1. feasibility of treatment

    Time frame: 12 months post reconstruction

    Functional testing of breathing Questionnaire of evaluation

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
First posted
Nov 17, 2010
Registry last updated
Aug 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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