Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

The Republican Research and Practical Center for Epidemiology and Microbiology

Status and phase: Completed; Phase 2; Phase 1

Conditions: Tracheal Stenosis; Mesenchymal Stem Cells; Laryngeal Stenosis

Treatments: Biological: Olfactory mucosa-derived mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT03130374

RRPCEM_MSC1

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.

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: 12 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Mesenchymal stem cell treated group

Experimental group

Description:

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

Treatment:

Biological: Olfactory mucosa-derived mesenchymal stem cells

Control group

No Intervention group

Description:

Patients treated according to current clinical protocols