Chronic Nasal Septum Perforation
Conditions
Brief 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.
Interventions
BIOLOGICALCollagen membrane + HUC-MSCs
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.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Chinese Academy of Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with nasal septum perforation area less than 1cm², and requires minimally-invasive treatment. 2. Male or female, 18-45 years old. 3. Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
Exclusion criteria
1. Cystic fibrosis, immotile cilia syndrome and other genetic diseases. 2. Syphilis, leprosy, tuberculosis and other specific infections. 3. Severe Sinusitis. 4. Autoimmune diseases or long term treatment with corticosteroids. 5. Alzheimer's disease. 6. Systemic diseases (e.g.,hypertension, diabetes and so on). 7. Previous history of nasal cancer or after receiving radiotherapy. 8. Drug abuse. 9. History of mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of integrity of nasal septum assessed by endoscopic examination | baseline, 1,2,3,4,8,12 weeks after surgery |
Secondary
| Measure | Time frame |
|---|---|
| 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 mucosal physiology assessed by olfactory test | 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 |
| The change of nasal obstructive symptom assessed by visual analogue scale (VAS) | baseline, 12 weeks after surgery |
Countries
China
Outcome results
None listed