Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

• Sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology (Other)
• Overall Status: Completed
• CT.gov ID: NCT03130374
• Collaborator: Belarusian Medical Academy of Post-Graduate Education (Other), The Republican Center for Research and Practice in Otolaryngology (Other)
• Enrollment: 12
• Locations: 2
• Arms: 2
• Actual Duration (Months): 28.5
• Patients Per Site: 6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Tracheal Stenosis; Laryngeal Stenosis; Mesenchymal Stem Cells	Biological: Olfactory mucosa-derived mesenchymal stem cells	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Laryngotracheal Stenosis Using Autologous Olfactory-mucosa-derived Mesenchymal Stem Cells
• Actual Study Start Date: Jan 3, 2017
• Actual Primary Completion Date: Jan 4, 2019
• Actual Study Completion Date: May 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mesenchymal stem cell treated group Patients treated according to current clinical protocols plus autologous olfactory mucosa-derived mesenchymal stem cells	Biological: Olfactory mucosa-derived mesenchymal stem cells; Olfactory mucosa-derived mesenchymal stem cells
No Intervention: Control group Patients treated according to current clinical protocols

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Tracheostomy decannulation [6 month]

   Removal of the tracheostomy tube after the treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Republican Center for Research and Practice in Otolaryngology	Minsk		Belarus	220000
2	The Republican Research and Practical Center for Epidemiology and Microbiology	Minsk		Belarus	220114

Sponsors and Collaborators

• 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

Investigators

• Principal Investigator: Andrei Y Hancharou, Dr, Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
• Study Chair: Valery L Chekan, Dr, Associate Professor of the Belarusian Medical Academy of Post-Graduate Education

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrei Y. Hancharou, Head of the Laboratory for Immunology and Cellular Biotechnology,, The Republican Research and Practical Center for Epidemiology and Microbiology
• ClinicalTrials.gov Identifier: NCT03130374
• Other Study ID Numbers: RRPCEM_MSC1
• First Posted: Apr 26, 2017
• Last Update Posted: Jun 7, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Andrei Y. Hancharou, Head of the Laboratory for Immunology and Cellular Biotechnology,, The Republican Research and Practical Center for Epidemiology and Microbiology: mesenchymal stem cells; Tracheal Stenosis; Laryngeal Stenosis; cell therapy
• Additional relevant MeSH terms: Tracheal Stenosis; Laryngostenosis; Constriction, Pathologic

Study Results

No Results Posted as of Jun 7, 2019