Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Status and phase: Invitation-only; Phase 2

Conditions: Tracheal Stenosis; Laryngeal Stenosis

Treatments: Biological: Olfactory mucosa-derived mesenchymal stem cells; Other: Patients treated according to current clinical protocols

Study type: Interventional

Funder types: Other

Identifiers

NCT05535803

IBCE_MSCStenosis

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Other: Patients treated according to current clinical protocols

Biological: Olfactory mucosa-derived mesenchymal stem cells

Patients with tracheal/laryngeal stenosis receiving standard treatment

Active Comparator group

Description:

Patients with tracheal/laryngeal stenosis receiving standard surgical treatment

Treatment:

Other: Patients treated according to current clinical protocols