NCT04633928

Nasal Septum Perforation Treatment Using Tissue Engineered Cartilage Graft

Repair of Nasal Septal Perforations Using (Autologous) Nasal Chondrocyte Tissue Engineered Cartilage (N-TEC)- a Phase I Clinical Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and feasibility of implanting an engineered cartilage tissue in an interposition graft with a temporoparietal fascia (TPF) flap to repair medium size septal perforation. The engineered cartilage graft is obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane. In addition, first data on efficacy will be collected.

Detailed description

Nasal septum perforation (NSP) is a medical condition characterized by loss of cartilage and/or bony structures of the nasal septum together with their mucoperichondrium and mucoperiosteum. There are many causes for NSP like history of nasal surgery (iatrogenic), trauma, self-inflicted injuries, drugs, chemical irritants, neoplastic causes, inflammatory causes (vasculitides, Wegener's granulomatosis) or infections (syphilis, tuberculosis). The perforation in the nasal septum creates pathological turbulences in the nasal airflow, which result in a decrease of the normal humidification process. Depending on size and location of the defect, this can lead to serious discomfort for patients and reduction of their quality of life. Since the current treatment methods (use of synthetic material, PDS, or of native cartilage) have disadvantages, the investigators want to show in a phase I study that the use of tissue engineered autologous nasal cartilage to repair perforations (holes) in the area of the nasal septum is suitable and safe. The engineered autologous nasal cartilage graft is used as a replacement for PDS or native cartilage in an interposition graft in the reconstruction of nasal septal perforations. Before the operation, the subjective symptoms of the patients are recorded using two questionnaires: Nasal Obstruction Symptom Evaluation (NOSE) and Visual Analog Scale (VAS) and objective examinations are carried out with functional tests (rhinomanometry, acoustic rhinometry) and imaging (endoscopy, CT scans). A small biopsy taken from the nasal septum is processed in the laboratory, chondrocytes are isolated, expanded and cultured onto a collagen matrix to generate a tissue engineered cartilage graft. Subsequently, the engineered cartilage is implanted into the defect of the nasal septum. In the postoperative follow up at 6 weeks, 3, 6 and 12 months, the investigators examine whether the nasal septum is closed, the subjective symptoms of the patients are recorded and the objective measurements are carried out in order to compare them with the findings before the operation. The aim of the study is to show safety and feasibility and to gain initial data on effectiveness of this treatment (improvement of symptoms).

Conditions

• Nasal Cartilage Septum Perforations

Interventions

Type	Name	Description
BIOLOGICAL	N-TEC: Autologous nasal chondrocytes and ECM proteins	Cells expanded in vitro and cultured in a collagen type I//III scaffold

Timeline

• Start date: 2021-04-09
• Primary completion: 2023-04-24
• Completion: 2023-04-24
• First posted: 2020-11-18
• Last updated: 2023-05-03

Locations

1 site across 1 country: Switzerland