Clinical Trial: Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Treatment of Laryngotracheal Stenosis Using Autologous Olfactory-mucosa-derived Mesenchymal Stem Cells

Brief Summary: The trial evaluates the safety and efficacy of the olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis

Detailed Summary:

Trial evaluating the safety and efficacy of olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis.

Mesenchymal stem cells are obtained from tissue biopsy of olfactory mucosa using explant method. Biomass of autologous mesenchymal stem cells in 10% human albumin solution is injected submucosally around and over the tissue after removal of a granuloma tissue during surgical intervention.


Sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology

Current Primary Outcome: Number of patients who didn't require the repeated surgical interventions [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Tracheostomy decannulation [ Time Frame: 6 month ]

Removal of the tracheostomy tube after the treatment.


Original Secondary Outcome: Same as current

Information By: The Republican Research and Practical Center for Epidemiology and Microbiology

Dates:
Date Received: April 12, 2017
Date Started: January 3, 2017
Date Completion: December 31, 2019
Last Updated: April 22, 2017
Last Verified: April 2017