Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

Phase 1

Completed

• Conditions: Laryngeal Stenosis; Mesenchymal Stem Cells; Tracheal Stenosis
• Interventions: Biological: Olfactory mucosa-derived mesenchymal stem cells

• Registration Number: NCT03130374
• Lead Sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology

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.

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: 2017-01-03
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-22
• Study First Posted: 2017-04-26
• Primary Completion: 2019-01-04
• Study Completion: 2019-05-20
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• confirmed diagnosis of chronic laryngeal or tracheal stenosis;
• absence of cartilage damage.

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
Mesenchymal stem cell treated group	Olfactory mucosa-derived mesenchymal stem cells	Patients treated according to current clinical protocols plus autologous olfactory mucosa-derived mesenchymal stem cells

Primary Outcome Measures

Name	Time	Method
Number of patients who didn't require the repeated surgical interventions	1 year

Secondary Outcome Measures

Name	Time	Method
Tracheostomy decannulation	6 month	Removal of the tracheostomy tube after the treatment.

Trial Locations

Locations (2)

The Republican Research and Practical Center for Epidemiology and Microbiology; 🇧🇾 Minsk, Belarus

The Republican Center for Research and Practice in Otolaryngology; 🇧🇾 Minsk, Belarus