Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule

Skin Carcinoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242618
• Other study ID #: TpP-I-2010-002
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2010
• Last updated: August 19, 2014
• Start date: October 2010

Study information

• Verified date: August 2014
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Skin Carcinoma

Intervention

Biological:
• engineered nasal cartilage graft
implantation of engineered nasal cartilage grafts in the alar lobule

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Fulco I, Largo RD, Miot S, Wixmerten A, Martin I, Schaefer DJ, Haug MD. Toward clinical application of tissue-engineered cartilage. Facial Plast Surg. 2013 Apr;29(2):99-105. doi: 10.1055/s-0033-1341589. Epub 2013 Apr 5. — View Citation

Fulco I, Miot S, Haug MD, Barbero A, Wixmerten A, Feliciano S, Wolf F, Jundt G, Marsano A, Farhadi J, Heberer M, Jakob M, Schaefer DJ, Martin I. Engineered autologous cartilage tissue for nasal reconstruction after tumour resection: an observational first — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety: post operative complications should not be at higher rate than gold standard operative procedure.	Post operative complications could be: infections, bleeding, formation of scar tissue, asymmetry of the nostril to the opposite side	12 months post reconstruction	Yes
Secondary	feasibility of treatment	Functional testing of breathing Questionnaire of evaluation	12 months post reconstruction	No