Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 16, 2010
CompletedFirst Posted
Study publicly available on registry
November 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedAugust 20, 2014
August 1, 2014
2.3 years
November 16, 2010
August 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
feasibility of treatment
12 months post reconstruction
Study Arms (1)
engineered nasal cartilage graft
EXPERIMENTALBiological intervention: autologous nasal chondrocytes expanded in vitro and cultured in a collagen Type I/III scaffold
Interventions
implantation of engineered nasal cartilage grafts in the alar lobule
Eligibility Criteria
You may qualify if:
- size of defect: ≥50% of alar subunit
- Extent of defect: 2 layer defect: skin and fibro-cartilaginous tissues
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Basel
Basel, 4031, Switzerland
Related 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.
PMID: 23564241BACKGROUNDFulco 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: 24726477RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Ivan Martin, Prof
University Hospital, Basel, Switzerland
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2010
First Posted
November 17, 2010
Study Start
October 1, 2010
Primary Completion
February 1, 2013
Last Updated
August 20, 2014
Record last verified: 2014-08