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Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01242618
First Posted: November 17, 2010
Last Update Posted: August 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
  Purpose
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 Intervention Phase
Skin Carcinoma Biological: engineered nasal cartilage graft Phase 1

Study Type: Interventional
Study Design: 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.

Further study details as provided by University Hospital, Basel, Switzerland:

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


Enrollment: 5
Study Start Date: October 2010
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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

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)
  Contacts and Locations
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


Locations
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Ivan Martin, Prof University Hospital, Basel, Switzerland
  More Information
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