Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tracheal Stenosis, Laryngeal Stenosis

Intervention / Treatment
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* Biological: Olfactory mucosa-derived mesenchymal stem cells
* Other: Patients treated according to current clinical protocols


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with tracheal/laryngeal stenosis receiving standard treatment and stem cells<br>Patients with tracheal/laryngeal stenosis receiving standard surgical treatment and mesenchymal stem cells | Biological: Olfactory mucosa-derived mesenchymal stem cells<br>* Autologous olfactory mucosa-derived mesenchymal stem cells<br>Other: Patients treated according to current clinical protocols<br>* Patients treated according to current clinical protocols<br>|
| Active Comparator: Patients with tracheal/laryngeal stenosis receiving standard treatment<br>Patients with tracheal/laryngeal stenosis receiving standard surgical treatment | Other: Patients treated according to current clinical protocols<br>* Patients treated according to current clinical protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who didn't require the repeated surgical interventions | Relative number of patients who didn't require the repeated surgical interventions after MSC therapy | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mesenchymal stem cells, Tracheal/Laryngeal Stenosis