Clinical Trial: Collagen Membrane Combined With HUC-MSCs Transplantation in Patients With Nasal Septum Perforation
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: The Safety and Efficacy Assessment of Collagen Membrane Combined With Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Patients With Nasal Septum Perfora
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 Summary:
Sponsor: Chinese Academy of Sciences
Current Primary Outcome: The change of integrity of nasal septum assessed by endoscopic examination [ Time Frame: baseline, 1,2,3,4,8,12 weeks after surgery ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Chinese Academy of Sciences
Dates:
Date Received: October 25, 2016
Date Started: November 2016
Date Completion: December 2019
Last Updated: November 19, 2016
Last Verified: October 2016
