NCT05535803

Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 description

Trial evaluating the safety and efficacy of olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis with/without cartilage defects 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.

Conditions

• Tracheal Stenosis
• Laryngeal Stenosis

Interventions

Type	Name	Description
BIOLOGICAL	Olfactory mucosa-derived mesenchymal stem cells	Autologous olfactory mucosa-derived mesenchymal stem cells
OTHER	Patients treated according to current clinical protocols	Patients treated according to current clinical protocols

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2022-09-10
• Last updated: 2022-09-10

Locations

1 site across 1 country: Belarus