Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule

• ClinicalTrials.gov Identifier: NCT01242618
• Recruitment Status: Completed
• First Posted: November 17, 2010
• Last Update Posted: August 20, 2014
• Sponsor: University Hospital, Basel, Switzerland
• Information provided by (Responsible Party): University Hospital, Basel, Switzerland

Tracking Information

• First Submitted Date: November 16, 2010
• First Posted Date: November 17, 2010
• Last Update Posted Date: August 20, 2014
• Study Start Date: October 2010
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 16, 2010)

safety: post operative complications should not be at higher rate than gold standard operative procedure. [ Time Frame: 12 months post reconstruction ]

Post operative complications could be: infections, bleeding, formation of scar tissue, asymmetry of the nostril to the opposite side

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 16, 2010)

feasibility of treatment [ Time Frame: 12 months post reconstruction ]

Functional testing of breathing Questionnaire of evaluation

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Skin Carcinoma

Intervention

Biological: engineered nasal cartilage graft

implantation of engineered nasal cartilage grafts in the alar lobule

Study Arms

Experimental: engineered nasal cartilage graft

Biological intervention: autologous nasal chondrocytes expanded in vitro and cultured in a collagen Type I/III scaffold

Intervention: Biological: engineered nasal cartilage graft

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 16, 2010): 5
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT01242618
• Other Study ID Numbers: TpP-I-2010-002
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital, Basel, Switzerland
• Original Responsible Party: Professor Ivan Martin, University Hospital Basel
• Current Study Sponsor: University Hospital, Basel, Switzerland
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ivan Martin, Prof; University Hospital, Basel, Switzerland

• PRS Account: University Hospital, Basel, Switzerland
• Verification Date: August 2014