Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells
Primary Purpose
Tracheal Stenosis, Laryngeal Stenosis, Mesenchymal Stem Cells
Status
Completed
Phase
Phase 1
Locations
Belarus
Study Type
Interventional
Intervention
Olfactory mucosa-derived mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Tracheal Stenosis focused on measuring mesenchymal stem cells, Tracheal Stenosis, Laryngeal Stenosis, cell therapy
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.
Sites / Locations
- The Republican Center for Research and Practice in Otolaryngology
- The Republican Research and Practical Center for Epidemiology and Microbiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mesenchymal stem cell treated group
Control group
Arm Description
Patients treated according to current clinical protocols plus autologous olfactory mucosa-derived mesenchymal stem cells
Patients treated according to current clinical protocols
Outcomes
Primary Outcome Measures
Number of patients who didn't require the repeated surgical interventions
Secondary Outcome Measures
Tracheostomy decannulation
Removal of the tracheostomy tube after the treatment.
Full Information
NCT ID
NCT03130374
First Posted
April 12, 2017
Last Updated
June 5, 2019
Sponsor
The Republican Research and Practical Center for Epidemiology and Microbiology
Collaborators
Belarusian Medical Academy of Post-Graduate Education, The Republican Center for Research and Practice in Otolaryngology
1. Study Identification
Unique Protocol Identification Number
NCT03130374
Brief Title
Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells
Official Title
Treatment of Laryngotracheal Stenosis Using Autologous Olfactory-mucosa-derived Mesenchymal Stem Cells
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
January 4, 2019 (Actual)
Study Completion Date
May 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Republican Research and Practical Center for Epidemiology and Microbiology
Collaborators
Belarusian Medical Academy of Post-Graduate Education, The Republican Center for Research and Practice in Otolaryngology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheal Stenosis, Laryngeal Stenosis, Mesenchymal Stem Cells
Keywords
mesenchymal stem cells, Tracheal Stenosis, Laryngeal Stenosis, cell therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mesenchymal stem cell treated group
Arm Type
Experimental
Arm Description
Patients treated according to current clinical protocols plus autologous olfactory mucosa-derived mesenchymal stem cells
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients treated according to current clinical protocols
Intervention Type
Biological
Intervention Name(s)
Olfactory mucosa-derived mesenchymal stem cells
Intervention Description
Olfactory mucosa-derived mesenchymal stem cells
Primary Outcome Measure Information:
Title
Number of patients who didn't require the repeated surgical interventions
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Tracheostomy decannulation
Description
Removal of the tracheostomy tube after the treatment.
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Y Hancharou, Dr
Organizational Affiliation
Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Valery L Chekan, Dr
Organizational Affiliation
Associate Professor of the Belarusian Medical Academy of Post-Graduate Education
Official's Role
Study Chair
Facility Information:
Facility Name
The Republican Center for Research and Practice in Otolaryngology
City
Minsk
ZIP/Postal Code
220000
Country
Belarus
Facility Name
The Republican Research and Practical Center for Epidemiology and Microbiology
City
Minsk
ZIP/Postal Code
220114
Country
Belarus
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells
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