Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01242618
First received: November 16, 2010
Last updated: August 19, 2014
Last verified: August 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01242618     History of Changes
Other Study ID Numbers: TpP-I-2010-002
Study First Received: November 16, 2010
Last Updated: August 19, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
nasal cartilage diseases

ClinicalTrials.gov processed this record on September 30, 2014