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Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03130374
Enrollment
12
Registered
2017-04-26
Start date
2017-01-03
Completion date
2019-05-20
Last updated
2019-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngeal Stenosis, Mesenchymal Stem Cells, Tracheal Stenosis

Keywords

mesenchymal stem cells, Tracheal Stenosis, Laryngeal Stenosis, cell therapy

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.

Interventions

BIOLOGICALOlfactory mucosa-derived mesenchymal stem cells

Olfactory mucosa-derived mesenchymal stem cells

Sponsors

Belarusian Medical Academy of Post-Graduate Education
CollaboratorOTHER
The Republican Center for Research and Practice in Otolaryngology
CollaboratorUNKNOWN
The Republican Research and Practical Center for Epidemiology and Microbiology
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Number of patients who didn't require the repeated surgical interventions1 year

Secondary

MeasureTime frameDescription
Tracheostomy decannulation6 monthRemoval of the tracheostomy tube after the treatment.

Countries

Belarus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026