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


Phase 1
18 Years
N/A
Not Enrolling
Both
Skin Carcinoma

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

12 months post reconstruction

Safety Issue:

Yes

Principal Investigator

Ivan Martin, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Basel, Switzerland

Authority:

Switzerland: Swissmedic

Study ID:

TpP-I-2010-002

NCT ID:

NCT01242618

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Skin Carcinoma
  • nasal cartilage diseases
  • Carcinoma
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Carcinoma, Basosquamous
  • Carcinoma, Squamous Cell

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