Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

Mesenchymal Stem Cells Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130374
• Other study ID #: RRPCEM_MSC1
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 3, 2017
• Est. completion date: May 20, 2019

Study information

• Verified date: June 2019
• Source: The Republican Research and Practical Center for Epidemiology and Microbiology
• Contact: n/a
• Is FDA regulated: No
• 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.

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: Completed
• Enrollment: 12
• Est. completion date: May 20, 2019
• Est. primary completion date: January 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Laryngeal Stenosis
• Laryngostenosis
• Mesenchymal Stem Cells
• Tracheal Stenosis

Intervention

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

Locations

Country	Name	City	State
Belarus	The Republican Center for Research and Practice in Otolaryngology	Minsk
Belarus	The Republican Research and Practical Center for Epidemiology and Microbiology	Minsk

Sponsors (3)

Lead Sponsor	Collaborator
The Republican Research and Practical Center for Epidemiology and Microbiology	Belarusian Medical Academy of Post-Graduate Education, 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		1 year
Secondary	Tracheostomy decannulation	Removal of the tracheostomy tube after the treatment.	6 month