Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule

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

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.

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)