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| Name | Class |
|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen membrane + HUC-MSCs | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen membrane + HUC-MSCs | Biological | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianwu Dai, Ph.D | Chinese Academy of Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
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| 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 |