Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells
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ClinicalTrials.gov Identifier: NCT03130374 |
Recruitment Status
:
Recruiting
First Posted
: April 26, 2017
Last Update Posted
: January 2, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tracheal Stenosis Laryngeal Stenosis Mesenchymal Stem Cells | Biological: Olfactory mucosa-derived mesenchymal stem cells | Phase 1 Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Estimated 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 : | January 3, 2017 |
Estimated Primary Completion Date : | June 30, 2019 |
Estimated Study Completion Date : | December 31, 2019 |
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
|
- Number of patients who didn't require the repeated surgical interventions [ Time Frame: 1 year ]
- Tracheostomy decannulation [ Time Frame: 6 month ]Removal of the tracheostomy tube after the treatment.

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130374
Contact: Andrei Y Hancharou, Dr | +375296248972 | andrei.hancharou@gmail.com | |
Contact: Natalia H Antonevich | +375295987406 | antonevich.n@gmail.com |
Belarus | |
The Republican Center for Research and Practice in Otolaryngology | Recruiting |
Minsk, Belarus, 220000 | |
Contact: Valery Chekan, Dr +375297072360 lor3377@yandex.ru | |
The Republican Research and Practical Center for Epidemiology and Microbiology | Recruiting |
Minsk, Belarus, 220114 | |
Contact: Andrei Hancharou, Dr +375296248972 andrei.hancharou@gmail.com | |
Contact: Natalia H Antonevich +375295987406 antonevich.n@gmail.com |
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 |
Additional Information:
Study Data/Documents: Informed Consent Form

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 History of Changes |
Other Study ID Numbers: |
RRPCEM_MSC1 |
First Posted: | April 26, 2017 Key Record Dates |
Last Update Posted: | January 2, 2018 |
Last Verified: | December 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
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, The Republican Research and Practical Center for Epidemiology and Microbiology:
mesenchymal stem cells Tracheal Stenosis Laryngeal Stenosis cell therapy |
Additional relevant MeSH terms:
Constriction, Pathologic Tracheal Stenosis Laryngostenosis Pathological Conditions, Anatomical Tracheal Diseases |
Respiratory Tract Diseases Laryngeal Diseases Otorhinolaryngologic Diseases Respiratory System Abnormalities Congenital Abnormalities |