Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells
NCT ID: NCT03130374
Last Updated: 2019-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2017-01-03
2019-05-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mesenchymal stem cell treated group
Patients treated according to current clinical protocols plus autologous olfactory mucosa-derived mesenchymal stem cells
Olfactory mucosa-derived mesenchymal stem cells
Olfactory mucosa-derived mesenchymal stem cells
Control group
Patients treated according to current clinical protocols
No interventions assigned to this group
Interventions
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Olfactory mucosa-derived mesenchymal stem cells
Olfactory mucosa-derived mesenchymal stem cells
Eligibility Criteria
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Inclusion Criteria
* absence of cartilage damage.
Exclusion Criteria
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Belarusian Medical Academy of Post-Graduate Education
OTHER
The Republican Center for Research and Practice in Otolaryngology
UNKNOWN
The Republican Research and Practical Center for Epidemiology and Microbiology
OTHER
Responsible Party
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Andrei Y. Hancharou
Head of the Laboratory for Immunology and Cellular Biotechnology,
Principal Investigators
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Andrei Y Hancharou, Dr
Role: PRINCIPAL_INVESTIGATOR
Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
Valery L Chekan, Dr
Role: STUDY_CHAIR
Associate Professor of the Belarusian Medical Academy of Post-Graduate Education
Locations
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The Republican Center for Research and Practice in Otolaryngology
Minsk, , Belarus
The Republican Research and Practical Center for Epidemiology and Microbiology
Minsk, , Belarus
Countries
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Other Identifiers
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RRPCEM_MSC1
Identifier Type: -
Identifier Source: org_study_id
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