Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule

NCT ID: NCT01242618

Last Updated: 2014-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31

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.

Conditions

Skin Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

engineered nasal cartilage graft

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

Group Type: EXPERIMENTAL

engineered nasal cartilage graft

Intervention Type: BIOLOGICAL

implantation of engineered nasal cartilage grafts in the alar lobule

Interventions

engineered nasal cartilage graft

implantation of engineered nasal cartilage grafts in the alar lobule

Intervention Type: BIOLOGICAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ivan Martin, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 23564241 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24726477 (View on PubMed)

Other Identifiers

TpP-I-2010-002

Identifier Type: -

Identifier Source: org_study_id