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
Sponsor study identifier
interventional
12
1 country
1
Study Start
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 25, 2016
Actual (reported)October 27, 2016
Actual (reported)November 2016
Date type not reportedThis date has not been verified as actual or estimated.
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The change of integrity of nasal septum assessed by endoscopic examination
baseline, 1,2,3,4,8,12 weeks after surgery
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Jianwu Dai, Ph.D
Chinese Academy of Sciences
First Submitted
October 25, 2016
First Posted
October 27, 2016
Study Start
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Contact the study team to confirm eligibility.
December 2021
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 5, 2021
Record last verified: 2016-10
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