Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

Phase 2

• Conditions: Tracheal Stenosis; Laryngeal Stenosis
• Interventions: Biological: Olfactory mucosa-derived mesenchymal stem cells; Other: Patients treated according to current clinical protocols

• Registration Number: NCT05535803
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

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 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.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2022-08-26
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-09
• Last Update Submitted: 2022-09-09
• Study First Posted: 2022-09-10
• Last Update Posted: 2022-09-10
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

-confirmed diagnosis of chronic laryngeal or tracheal stenosis;

Exclusion Criteria

• refuse of patient to participate in the trial;
• acute infectious diseases;
• chronic mental disorders with severe manifestations;
• pregnancy/lactation;
• intercurrent severe chronic diseases;
• HIV, Hepatites B/C;
• active tuberculosis;
• alcohol use disorder/drug addiction;
• cachexia of any origin;
• malignant neoplasms.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with tracheal/laryngeal stenosis receiving standard treatment and stem cells	Olfactory mucosa-derived mesenchymal stem cells	Patients with tracheal/laryngeal stenosis receiving standard surgical treatment and mesenchymal stem cells
Patients with tracheal/laryngeal stenosis receiving standard treatment	Patients treated according to current clinical protocols	Patients with tracheal/laryngeal stenosis receiving standard surgical treatment
Patients with tracheal/laryngeal stenosis receiving standard treatment and stem cells	Patients treated according to current clinical protocols	Patients with tracheal/laryngeal stenosis receiving standard surgical treatment and mesenchymal stem cells

Primary Outcome Measures

Name	Time	Method
Number of patients who didn't require the repeated surgical interventions	1 year	Relative number of patients who didn't require the repeated surgical interventions after MSC therapy

Trial Locations

Locations (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus; 🇧🇾 Minsk, Belarus