Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05535803

Enrollment

Registered

2022-09-10

Start date

2021-06-01

Completion date

2023-06-30

Last updated

2022-09-10

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

Conditions

Laryngeal Stenosis, Tracheal Stenosis

Keywords

mesenchymal stem cells, Tracheal/Laryngeal Stenosis

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 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.

Interventions

BIOLOGICALOlfactory mucosa-derived mesenchymal stem cells

Autologous olfactory mucosa-derived mesenchymal stem cells

OTHERPatients treated according to current clinical protocols

Patients treated according to current clinical protocols

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

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.

Design outcomes

Primary

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

Countries

Belarus

Outcome results

None listed

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