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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Basel, Schweiz, 4031
- University Hospital Basel
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: engineered nasal cartilage graft
Biological intervention: autologous nasal chondrocytes expanded in vitro and cultured in a collagen Type I/III scaffold
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implantation of engineered nasal cartilage grafts in the alar lobule
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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safety: post operative complications should not be at higher rate than gold standard operative procedure.
Tidsramme: 12 months post reconstruction
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Post operative complications could be: infections, bleeding, formation of scar tissue, asymmetry of the nostril to the opposite side
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12 months post reconstruction
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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feasibility of treatment
Tidsramme: 12 months post reconstruction
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Functional testing of breathing Questionnaire of evaluation
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12 months post reconstruction
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Ivan Martin, Prof, University Hospital, Basel, Switzerland
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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-in-human trial. Lancet. 2014 Jul 26;384(9940):337-46. doi: 10.1016/S0140-6736(14)60544-4. Epub 2014 Apr 10.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- TpP-I-2010-002
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