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| Name | Class |
|---|---|
| Belarusian Medical Academy of Post-Graduate Education | OTHER |
| 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.
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 |
|---|---|---|---|
| Mesenchymal stem cell treated group | Experimental | Patients treated according to current clinical protocols plus autologous olfactory mucosa-derived mesenchymal stem cells |
|
| Control group | No Intervention | Patients treated according to current clinical protocols |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olfactory mucosa-derived mesenchymal stem cells | Biological | Olfactory mucosa-derived mesenchymal stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who didn't require the repeated surgical interventions | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Tracheostomy decannulation | Removal of the tracheostomy tube after the treatment. | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrei Y Hancharou, Dr | Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology | Principal Investigator |
| Valery L Chekan, Dr | Associate Professor of the Belarusian Medical Academy of Post-Graduate Education | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Republican Center for Research and Practice in Otolaryngology | Minsk | 220000 | Belarus | |||
| The Republican Research and Practical Center for Epidemiology and Microbiology |
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| Label | URL |
|---|---|
| Article in Russian | View source |
| Article in Russian | View source |
| Abstract |
| ID | Type | URL | Comment |
|---|---|---|---|
| Informed Consent Form | View IPD |
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| ID | Term |
|---|---|
| D014135 | Tracheal Stenosis |
| D007829 | Laryngostenosis |
| ID | Term |
|---|---|
| D014133 | Tracheal Diseases |
| D012140 | Respiratory Tract Diseases |
| D007818 | Laryngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Minsk |
| 220114 |
| Belarus |
| Abstract | View source |
| Abstract | View source |
| Study Protocol | View IPD |
| D015619 | Respiratory System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |