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

Chinese Academy of Sciences1 site in 1 country12 target enrollmentNovember 2016

ConditionsChronic Nasal Septum Perforation

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic Nasal Septum Perforation
Sponsor: Chinese Academy of Sciences
Enrollment: 12
Locations: 1
Primary Endpoint: The change of integrity of nasal septum assessed by endoscopic examination
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2016

End Date

December 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chinese Academy of Sciences

Responsible Party

Principal Investigator

Jianwu Dai

Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Chinese Academy of Sciences

Eligibility Criteria

Inclusion Criteria

•Patients with nasal septum perforation area less than 1cm², and requires minimally-invasive treatment.
•Male or female, 18-45 years old.
•Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.

Exclusion Criteria

•Cystic fibrosis, immotile cilia syndrome and other genetic diseases.
•Syphilis, leprosy, tuberculosis and other specific infections.
•Severe Sinusitis.
•Autoimmune diseases or long term treatment with corticosteroids.
•Alzheimer's disease.
•Systemic diseases (e.g.,hypertension, diabetes and so on).
•Previous history of nasal cancer or after receiving radiotherapy.
•Drug abuse.
•History of mental illness.

Outcomes

Primary Outcomes

The change of integrity of nasal septum assessed by endoscopic examination

Time Frame: baseline, 1,2,3,4,8,12 weeks after surgery

Secondary Outcomes

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