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

Phase 1

• Conditions: Chronic Nasal Septum Perforation
• Interventions: Biological: Collagen membrane + HUC-MSCs

• Registration Number: NCT02947191
• Lead Sponsor: Chinese Academy of Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Study Start: 2016-11
• Last Update Submitted: 2020-12-31
• Last Update Posted: 2021-01-05
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Collagen membrane + HUC-MSCs	Collagen membrane + HUC-MSCs	-

Primary Outcome Measures

Name	Time	Method
The change of integrity of nasal septum assessed by endoscopic examination	baseline, 1,2,3,4,8,12 weeks after surgery

Secondary Outcome Measures

Name	Time	Method
Change from baseline in computed tomography (CT)	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
The change of nasal mucosal physiology assessed by olfactory test	baseline, 12 weeks after surgery

Trial Locations

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China