Skin Carcinoma
Conditions
Keywords
nasal cartilage diseases
Brief 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.
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.
Interventions
BIOLOGICALengineered nasal cartilage graft
implantation of engineered nasal cartilage grafts in the alar lobule
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety: post operative complications should not be at higher rate than gold standard operative procedure. | 12 months post reconstruction | Post operative complications could be: infections, bleeding, formation of scar tissue, asymmetry of the nostril to the opposite side |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| feasibility of treatment | 12 months post reconstruction | Functional testing of breathing Questionnaire of evaluation |
Countries
Switzerland
Outcome results
None listed