Nasal Cartilage Septum PerforationsPhase 1NSPNCT04633928
Nasal Septum Perforation Treatment Using Tissue Engineered Cartilage Graft
A Phase 1 study testing N-TEC: Autologous nasal chondrocytes and ECM proteins in people with Nasal Cartilage Septum Perforations, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Cartilage Septum Perforations
- What is being tested?
- N-TEC: Autologous nasal chondrocytes and ECM proteins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Apr 2021to 24 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Repair of Nasal Septal Perforations Using (Autologous) Nasal Chondrocyte Tissue Engineered Cartilage (N-TEC)- a Phase I Clinical Trial
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.
Read the 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
- Being tested
- N-TEC: Autologous nasal chondrocytes and ECM proteins
- Keywords
- Nasal chondrocytes, Nasal cartilage diseases, Septum perforation, Tissue engineering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-TEC: Autologous nasal chondrocytes and ECM proteinsBiological
Cells expanded in vitro and cultured in a collagen type I//III scaffold
| Study group | Role | What they receive |
|---|---|---|
| N-TEC | Experimental | N-TEC is based on autologous nasal chondrocytes expanded and further cultured on type I/III collagen membranes for about 2 weeks to allow cells to produce extracellular matrix containing cartilage specific proteins. The tissue engineered graft is then implanted in the nasal septum in an interposition graft with a temporoparietal fascia flap. Receives: Biological: N-TEC: Autologous nasal chondrocytes and ECM proteins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment
measured by reporting adverse events and reactions
Measured: one year follow up after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start9 Apr 2021
- Primary completion24 Apr 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal Cartilage Septum PerforationsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Josef Vavrina, HNO Seepraxen, CH-8810 Horgen, Zurich
- Responsible party
- Sponsor
- Investigators
- Martin Haug, Prof, Principal investigator, University Hospital Basel, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633928
- Sponsor's protocol ID
- 2020-02431
- Acronym
- NSP
- Status last verified
- Apr 2023
- First submitted
- 11 Nov 2020
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaiser B, Miot S, Wixmerten A, Pullig O, Eyrich M, Fulco I, Vavrina J, Schaefer DJ, Martin I, Barbero A, Haug MD. Engineered autologous nasal cartilage for repair of nasal septal perforations: a case series. Int J Surg. 2024 Oct 1;110(10):6573-6580. doi: 10.1097/JS9.0000000000001843.
PubMed 39197067
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repair of Nasal Septal Perforations Using (Autologous) Nasal Chondrocyte Tissue Engineered Cartilage (N-TEC)- a Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT04633928
- Acronym / sponsor ID
- NSP / 2020-02431
- Conditions
- Nasal Cartilage Septum Perforations
- Keywords
- Nasal chondrocytes, Nasal cartilage diseases, Septum perforation, Tissue engineering
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Dr Josef Vavrina, HNO Seepraxen, CH-8810 Horgen, Zurich
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N-TEC | Experimental | Biological: N-TEC: Autologous nasal chondrocytes and ECM proteinsN-TEC is based on autologous nasal chondrocytes expanded and further cultured on type I/III collagen membranes for about 2 weeks to allow cells to produce extracellular matrix containing cartilage specific proteins. The tissue engineered graft is then implanted in the nasal septum in an interposition graft with a temporoparietal fascia flap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Nasal septal perforation of a medium size (diameter 0.5 to 2.0 cm), measured by endoscopy
Key exclusion criteria (21 listed)
- • Nasal septal perforation of a small (<0.5 cm) or large size (>2.0 cm)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-TEC: Autologous nasal chondrocytes and ECM proteinsCells expanded in vitro and cultured in a collagen type I//III scaffold | Biological | N-TEC |
Primary outcome
Safety assessment
Time frame: one year follow up after implantation
measured by reporting adverse events and reactions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Derived from this study: PubMed 39197067Kaiser B, Miot S, Wixmerten A, Pullig O, Eyrich M, Fulco I, Vavrina J, Schaefer DJ, Martin I, Barbero A, Haug MD. Engineered autologous nasal cartilage for repair of nasal septal perforations: a case series. Int J Surg. 2024 Oct 1;110(10):6573-6580. doi: 10.1097/JS9.0000000000001843.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Haug, Prof principal investigator
University Hospital Basel, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing N-TEC: Autologous nasal chondrocytes and ECM proteins in people with Nasal Cartilage Septum Perforations, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment (time frame: one year follow up after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04633928, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.