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NCT05535803 Clinical Trial

Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

Tracheal Stenosis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05535803
Other study ID # IBCE_MSCStenosis
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date June 1, 2021
Est. completion date June 30, 2023

Study information
Verified date September 2022
Source Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 20
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Olfactory mucosa-derived mesenchymal stem cells
Autologous olfactory mucosa-derived mesenchymal stem cells
Other:
• Patients treated according to current clinical protocols
Patients treated according to current clinical protocols

Locations
Country Name City State
Belarus Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus Minsk

Sponsors (2)
Lead Sponsor Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus The Republican Center for Research and Practice in Otolaryngology

Country where clinical trial is conducted

Belarus, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients who didn't require the repeated surgical interventions Relative number of patients who didn't require the repeated surgical interventions after MSC therapy 1 year
See also
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