Clinical trial · Interventional
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.
NCT01242618CI-TRIAL-00015422completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Carcinoma | Skin Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| engineered nasal cartilage graft | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- engineered nasal cartilage graft
- description
- Biological intervention: autologous nasal chondrocytes expanded in vitro and cultured in a collagen Type I/III scaffold
- interventionNames
- Biological: engineered nasal cartilage graft
Primary outcomes (1)
- measure
- safety: post operative complications should not be at higher rate than gold standard operative procedure.
- timeFrame
- 12 months post reconstruction
- description
- Post operative complications could be: infections, bleeding, formation of scar tissue, asymmetry of the nostril to the opposite side
Secondary outcomes (1)
- measure
- feasibility of treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (2)
- BACKGROUNDFulco 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. PMID 23564241
- RESULTFulco 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-in-human trial. Lancet. 2014 Jul 26;384(9940):337-46. doi: 10.1016/S0140-6736(14)60544-4. Epub 2014 Apr 10. PMID 24726477