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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
The change of integrity of nasal septum assessed by endoscopic examination
Time frame: baseline, 1,2,3,4,8,12 weeks after surgery
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
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