Chronic Nasal Septum PerforationPhase 1/2NCT02947191
Collagen Membrane Combined With HUC-MSCs Transplantation in Patients With Nasal Septum Perforation
A Phase 1/2 study testing Collagen membrane + HUC-MSCs in people with Chronic Nasal Septum Perforation, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
The purpose of this study is to assess the safety and efficacy of collagen membrane combined with human clinical grade umbilical cord mesenchymal stem cells(HUC-MSCs) transplantation in patients with chronic nasal septum perforation. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Chronic Nasal Septum Perforation
- What is being tested?
- Collagen membrane + HUC-MSCs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Dec 2021
- Phase
- Phase 1/2
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with nasal septum perforation area less than 1cm², and requires minimally-invasive treatment.
- Male or female, 18-45 years old.
- Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
Who cannot join
- Cystic fibrosis, immotile cilia syndrome and other genetic diseases.
- Syphilis, leprosy, tuberculosis and other specific infections.
- Severe Sinusitis.
- Autoimmune diseases or long term treatment with corticosteroids.
- Alzheimer's disease.
- Systemic diseases (e.g.,hypertension, diabetes and so on).
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- Previous history of nasal cancer or after receiving radiotherapy.
- Drug abuse.
- History of mental illness.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
About this study
Official title: The Safety and Efficacy Assessment of Collagen Membrane Combined With Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Patients With Nasal Septum Perforation
The purpose of this study is to assess the safety and efficacy of collagen membrane combined with human clinical grade umbilical cord mesenchymal stem cells(HUC-MSCs) transplantation in patients with chronic nasal septum perforation.
- Conditions
- Chronic Nasal Septum Perforation
- Being tested
- Collagen membrane + HUC-MSCs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen membrane + HUC-MSCsBiological
After separating bilateral nasal septum mucosas via septum reconstruction incision under endoscopy, the clinical grade HUC-MSCs combined with collagen membrane will be transplanted between the bilateral nasal septum mucosas and fixed. The patients will be treated with antibiotics for 1 week, and with naristillae menthae compositae, mucus promoting agent and other drugs for improving microcirculation for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Collagen membrane + HUC-MSCs | Experimental | Not described Receives: Biological: Collagen membrane + HUC-MSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of integrity of nasal septum assessed by endoscopic examination
Measured: baseline, 1,2,3,4,8,12 weeks after surgery
Secondary outcomes (7)
The change of nasal mucosal physiology assessed by olfactory test
Measured: baseline, 12 weeks after surgery
The change of nasal mucosal physiology assessed by nasal mucociliary clearance time (MCT)
Measured: baseline, 12 weeks after surgery
The change of nasal airway resistance assessed by rhinomanometry
Measured: baseline, 12 weeks after surgery
The change of nasal obstruction assessed by acoustic rhinometry
Measured: baseline, 12 weeks after surgery
The change of nasal obstructive symptom assessed by visual analogue scale (VAS)
Measured: baseline, 12 weeks after surgery
The change of nasal symptom severity assessed by total nasal symptom score (TNSS)
Measured: baseline, 12 weeks after surgery
Change from baseline in computed tomography (CT)
Measured: baseline, 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Nasal Septum PerforationStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jianwu Dai, Chinese Academy of Sciences
- Investigators
- Jianwu Dai, Ph.D, Principal investigator, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947191
- Sponsor's protocol ID
- CAS-XDA-NSP/IGDB
- Status last verified
- Oct 2016
- First submitted
- 25 Oct 2016
- Last updated
- 5 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy Assessment of Collagen Membrane Combined With Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Patients With Nasal Septum Perforation
- ClinicalTrials.gov ID
- NCT02947191
- Acronym / sponsor ID
- CAS-XDA-NSP/IGDB
- Conditions
- Chronic Nasal Septum Perforation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- Nov 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 27 Oct 2016 (estimated)
- 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 assess the safety and efficacy of collagen membrane combined with human clinical grade umbilical cord mesenchymal stem cells(HUC-MSCs) transplantation in patients with chronic nasal septum perforation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collagen membrane + HUC-MSCs | Experimental | Biological: Collagen membrane + HUC-MSCs |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with nasal septum perforation area less than 1cm², and requires minimally-invasive treatment.
- Male or female, 18-45 years old.
- Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
Key exclusion criteria (9 listed)
- Cystic fibrosis, immotile cilia syndrome and other genetic diseases.
- Syphilis, leprosy, tuberculosis and other specific infections.
- Severe Sinusitis.
- Autoimmune diseases or long term treatment with corticosteroids.
- Alzheimer's disease.
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 |
|---|---|---|
| Collagen membrane + HUC-MSCsAfter separating bilateral nasal septum mucosas via septum reconstruction incision under endoscopy, the clinical grade HUC-MSCs combined with collagen membrane will be transplanted between the bilateral nasal septum mucosas and fixed. The patients will be treated with antibiotics for 1 week, and with naristillae menthae compositae, mucus promoting agent and other drugs for improving microcirculation for 1 month. | Biological | Collagen membrane + HUC-MSCs |
Primary outcome
The change of integrity of nasal septum assessed by endoscopic examination
Time frame: baseline, 1,2,3,4,8,12 weeks after surgery
7 secondary outcomes
The change of nasal mucosal physiology assessed by olfactory test
Time frame: baseline, 12 weeks after surgery
The change of nasal mucosal physiology assessed by nasal mucociliary clearance time (MCT)
Time frame: baseline, 12 weeks after surgery
The change of nasal airway resistance assessed by rhinomanometry
Time frame: baseline, 12 weeks after surgery
The change of nasal obstruction assessed by acoustic rhinometry
Time frame: baseline, 12 weeks after surgery
The change of nasal obstructive symptom assessed by visual analogue scale (VAS)
Time frame: baseline, 12 weeks after surgery
The change of nasal symptom severity assessed by total nasal symptom score (TNSS)
Time frame: baseline, 12 weeks after surgery
Change from baseline in computed tomography (CT)
Time frame: baseline, 12 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
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.
Jianwu Dai, Ph.D principal investigator
Chinese Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Collagen membrane + HUC-MSCs in people with Chronic Nasal Septum Perforation, run by Chinese Academy of Sciences at 1 site in China.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 5 Jan 2021. 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 China. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The change of integrity of nasal septum assessed by endoscopic examination (time frame: baseline, 1,2,3,4,8,12 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.