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| Name | Class |
|---|---|
| The Republican Center for Research and Practice in Otolaryngology | UNKNOWN |
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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
Trial evaluating the safety and efficacy of olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis with/without cartilage defects
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with tracheal/laryngeal stenosis receiving standard treatment and stem cells | Experimental | Patients with tracheal/laryngeal stenosis receiving standard surgical treatment and mesenchymal stem cells |
|
| Patients with tracheal/laryngeal stenosis receiving standard treatment | Active Comparator | Patients with tracheal/laryngeal stenosis receiving standard surgical treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olfactory mucosa-derived mesenchymal stem cells | Biological | Autologous olfactory mucosa-derived mesenchymal stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who didn't require the repeated surgical interventions | Relative number of patients who didn't require the repeated surgical interventions after MSC therapy | 1 year |
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Inclusion Criteria:
-confirmed diagnosis of chronic laryngeal or tracheal stenosis;
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrei Hancharou, Dr | Institute for biophysics and cellular engineering NAS of Belarus | Study Director |
| Elvira Strinkevich, Dr | The Republican Center for Research and Practice in Otolaryngology | Study Director |
| Valery Chekan, Dr | The Republican Center for Research and Practice in Otolaryngology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus | Minsk | 220072 | Belarus |
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| Patients treated according to current clinical protocols | Other | Patients treated according to current clinical protocols |
|
| ID | Term |
|---|---|
| D014135 | Tracheal Stenosis |
| D007829 | Laryngostenosis |
| ID | Term |
|---|---|
| D014133 | Tracheal Diseases |
| D012140 | Respiratory Tract Diseases |
| D007818 | Laryngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D015619 | Respiratory System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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