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

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

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 Overview

• Status: Unknown
• Conditions: Chronic Nasal Septum Perforation
• Intervention / Treatment: Biological: Collagen membrane + HUC-MSCs

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Collagen membrane + HUC-MSCs

Biological: Collagen 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimate): October 27, 2016

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 31, 2020
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Wounds and Injuries; Otorhinolaryngologic Diseases; Nose Diseases; Nasal Septal Perforation
• Other Study ID Numbers: CAS-XDA-NSP/IGDB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No