Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

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

Sponsors

Lead Sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology

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

Source The Republican Research and Practical Center for Epidemiology and Microbiology
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.

Overall Status Completed
Start Date January 3, 2017
Completion Date May 20, 2019
Primary Completion Date January 4, 2019
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of patients who didn't require the repeated surgical interventions 1 year
Secondary Outcome
Measure Time Frame
Tracheostomy decannulation 6 month
Enrollment 12
Condition
Intervention

Intervention Type: Biological

Intervention Name: Olfactory mucosa-derived mesenchymal stem cells

Description: Olfactory mucosa-derived mesenchymal stem cells

Arm Group Label: Mesenchymal stem cell treated group

Eligibility

Criteria:

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: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Healthy Volunteers: No

Overall Official
Location
Facility:
The Republican Center for Research and Practice in Otolaryngology | Minsk, 220000, Belarus
The Republican Research and Practical Center for Epidemiology and Microbiology | Minsk, 220114, Belarus
Location Countries

Belarus

Verification Date

June 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: The Republican Research and Practical Center for Epidemiology and Microbiology

Investigator Full Name: Andrei Y. Hancharou

Investigator Title: Head of the Laboratory for Immunology and Cellular Biotechnology,

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Mesenchymal stem cell treated group

Type: Experimental

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

Label: Control group

Type: No Intervention

Description: Patients treated according to current clinical protocols

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov