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

2020-02431

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.

2021-04-09

2023-04-24

2023-04-24

Completed

Early phase I

5

Inclusion Criteria: * • Nasal septal perforation of a medium size (diameter 0.5 to 2.0 cm), measured by endoscopy * Age above or equal to 18 years * Informed Consent as documented by signature * Patient is willing and able to give written informed consent to participate in the study and to comply with all study requirements, including attending all follow-up visits and assessments Exclusion Criteria: * • Nasal septal perforation of a small (\<0.5 cm) or large size (\>2.0 cm) * Patient is smoking * Known or suspected non-compliance, drug (especially cocaine) or alcohol abuse * Evidence of infection with HIV or hepatitis B or C, syphilis. Patients with a cured hepatitis B or C infection and/or verified antibodies are not excluded. * Known allergies to porcine collagen, penicillin or streptomycin * Women who are pregnant or breast feeding * Intention to become pregnant during the course of the study * Chronic treatment with steroids or immunomodulatory drugs * Diabetes * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol or in a dependency or employment with the sponsor. * Patient is unable to understand the patient information * Patient has a known systemic connective tissue disease. * Patient has a known autoimmune disease. * Patient has a known immunological suppressive disorder or is taking immunosuppressive. * Patient is currently systemically or intra-articularly taking steroids and/or has used steroids within the 30 days prior to the planned treatment. * The patient has at the site of surgery an active systemic or local microbial infection, eczematization or inflammable skin alterations (including Protozoonosis: Babesiosis, Trypanosomiasis (e.g. Chagas-Disease), Leishmaniasis, persistent bacterial infections, such as Brucellosis, spotted and typhus fever, other Rickettsiosis, Leprosy, Recurrent Fever, Melioidosis or Tularaemia). * Patient has an active cancer. * Patient is currently participating, or has participated in any other clinical study within 3 months prior to the screening visit. * Patient has any other condition, which, in the opinion of the investigator, would make the patient unsuitable for the study. * Patient is unable to tolerate local anesthesia

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}

2023-05-03