Collagen Membrane Combined With HUC-MSCs Transplantation in Patients With Nasal Septum Perforation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Nasal Septum Perforation

Intervention / Treatment
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* Biological: Collagen membrane + HUC-MSCs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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). Previous history of nasal cancer or after receiving radiotherapy. Drug abuse. History of mental illness.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collagen membrane + HUC-MSCs<br> | Biological: Collagen membrane + HUC-MSCs<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of integrity of nasal septum assessed by endoscopic examination |  | baseline, 1,2,3,4,8,12 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of nasal mucosal physiology assessed by olfactory test |  | baseline, 12 weeks after surgery | 
| The change of nasal mucosal physiology assessed by nasal mucociliary clearance time (MCT) |  | baseline, 12 weeks after surgery | 
| The change of nasal airway resistance assessed by rhinomanometry |  | baseline, 12 weeks after surgery | 
| The change of nasal obstruction assessed by acoustic rhinometry |  | baseline, 12 weeks after surgery | 
| The change of nasal obstructive symptom assessed by visual analogue scale (VAS) |  | baseline, 12 weeks after surgery | 
| The change of nasal symptom severity assessed by total nasal symptom score (TNSS) |  | baseline, 12 weeks after surgery | 
| Change from baseline in computed tomography (CT) |  | baseline, 12 weeks after surgery |