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Completed

NCT Number: NCT03130374

Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

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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Key information

Conditions

Tracheal Stenosis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Laryngeal Diseases Laryngeal Stenosis Laryngostenosis Mesenchymal Stem Cells Otorhinolaryngologic Diseases Respiratory System Abnormalities Respiratory Tract Diseases Tracheal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Republican Center for Research and Practice in Otolaryngology, Minsk, Belarus

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olfactory mucosa-derived mesenchymal stem cells

Biological

Olfactory mucosa-derived mesenchymal stem cells

Primary outcomes

  1. Number of patients who didn't require the repeated surgical interventions

    Time frame: 1 year

Secondary outcomes

  1. Tracheostomy decannulation

    Time frame: 6 month

    Removal of the tracheostomy tube after the treatment.

Sponsors and collaborators

Lead sponsor

The Republican Research and Practical Center for Epidemiology and Microbiology

Other

Collaborators

  • Belarusian Medical Academy of Post-Graduate Education
  • The Republican Center for Research and Practice in Otolaryngology

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2017
Registry last updated
Jun 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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