Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-06-30

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

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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.

Conditions

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Tracheal Stenosis Laryngeal Stenosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with tracheal/laryngeal stenosis receiving standard treatment and stem cells

Patients with tracheal/laryngeal stenosis receiving standard surgical treatment and mesenchymal stem cells

Group Type EXPERIMENTAL

Olfactory mucosa-derived mesenchymal stem cells

Intervention Type BIOLOGICAL

Autologous olfactory mucosa-derived mesenchymal stem cells

Patients treated according to current clinical protocols

Intervention Type OTHER

Patients treated according to current clinical protocols

Patients with tracheal/laryngeal stenosis receiving standard treatment

Patients with tracheal/laryngeal stenosis receiving standard surgical treatment

Group Type ACTIVE_COMPARATOR

Patients treated according to current clinical protocols

Intervention Type OTHER

Patients treated according to current clinical protocols

Interventions

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Olfactory mucosa-derived mesenchymal stem cells

Autologous olfactory mucosa-derived mesenchymal stem cells

Intervention Type BIOLOGICAL

Patients treated according to current clinical protocols

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No