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Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule

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ClinicalTrials.gov Identifier: NCT01242618
Recruitment Status : Completed
First Posted : November 17, 2010
Last Update Posted : August 20, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Skin Carcinoma Biological: engineered nasal cartilage graft Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : October 2010
Actual Primary Completion Date : February 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  1. feasibility of treatment [ Time Frame: 12 months post reconstruction ]
    Functional testing of breathing Questionnaire of evaluation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242618

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University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
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Principal Investigator: Ivan Martin, Prof University Hospital, Basel, Switzerland
Publications of Results:
Other Publications:
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01242618    
Other Study ID Numbers: TpP-I-2010-002
First Posted: November 17, 2010    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014
Keywords provided by University Hospital, Basel, Switzerland:
nasal cartilage diseases