Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

Overview

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 Title of Study: “Treatment of Laryngotracheal Stenosis Using Autologous Olfactory-mucosa-derived Mesenchymal Stem Cells”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 4, 2019

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

  • Biological: Olfactory mucosa-derived mesenchymal stem cells
    • Olfactory mucosa-derived mesenchymal stem cells

Arms, Groups and Cohorts

  • Experimental: Mesenchymal stem cell treated group
    • Patients treated according to current clinical protocols plus autologous olfactory mucosa-derived mesenchymal stem cells
  • No Intervention: Control group
    • Patients treated according to current clinical protocols

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients who didn’t require the repeated surgical interventions
    • Time Frame: 1 year

Secondary Measures

  • Tracheostomy decannulation
    • Time Frame: 6 month
    • Removal of the tracheostomy tube after the treatment.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Republican Research and Practical Center for Epidemiology and Microbiology
  • Collaborator
    • Belarusian Medical Academy of Post-Graduate Education
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andrei Y. Hancharou, Head of the Laboratory for Immunology and Cellular Biotechnology, – The Republican Research and Practical Center for Epidemiology and Microbiology
  • Overall Official(s)
    • Andrei Y Hancharou, Dr, Principal Investigator, Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
    • Valery L Chekan, Dr, Study Chair, Associate Professor of the Belarusian Medical Academy of Post-Graduate Education

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