Tracheal StenosisPhase 2NCT05535803
Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells
A Phase 2 study testing Olfactory mucosa-derived mesenchymal stem cells and Patients treated according to current clinical protocols in people with Tracheal Stenosis and Laryngeal Stenosis, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tracheal Stenosis, Laryngeal Stenosis
- What is being tested?
- Olfactory mucosa-derived mesenchymal stem cells and Patients treated according to current clinical protocols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jun 2021to 30 Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -confirmed diagnosis of chronic laryngeal or tracheal stenosis;
Who cannot join
- 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;
Show all 10Show fewer
- active tuberculosis;
- alcohol use disorder/drug addiction;
- cachexia of any origin;
- malignant neoplasms.
Trial locations and contacts
1 site in 1 country.
Belarus1 site
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, 220072
About this study
Official title: Treatment of Laryngotracheal Stenosis Using Autologous Olfactory-mucosa-derived Mesenchymal Stem Cells
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
Read the 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 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.
- Conditions
- Tracheal Stenosis, Laryngeal Stenosis
- Being tested
- Olfactory mucosa-derived mesenchymal stem cells, Patients treated according to current clinical protocols
- Keywords
- mesenchymal stem cells, Tracheal/Laryngeal Stenosis
- Medical subject headings
- Tracheal Stenosis, Laryngostenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olfactory mucosa-derived mesenchymal stem cellsBiological
Autologous olfactory mucosa-derived mesenchymal stem cells
Patients treated according to current clinical protocolsOther
Patients treated according to current clinical protocols
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Olfactory mucosa-derived mesenchymal stem cells; Other: Patients treated according to current clinical protocols |
| Patients with tracheal/laryngeal stenosis receiving standard treatment | Active comparator | Patients with tracheal/laryngeal stenosis receiving standard surgical treatment Receives: Other: Patients treated according to current clinical protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Jun 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Sponsor type
- Other government
- Collaborators
- The Republican Center for Research and Practice in Otolaryngology
- Responsible party
- Sponsor
- Investigators
- Andrei Hancharou, Dr, Study director, Institute for biophysics and cellular engineering NAS of BelarusElvira Strinkevich, Dr, Study director, The Republican Center for Research and Practice in OtolaryngologyValery Chekan, Dr, Study director, The Republican Center for Research and Practice in Otolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535803
- Sponsor's protocol ID
- IBCE_MSCStenosis
- Status last verified
- Sep 2022
- First submitted
- 26 Aug 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Laryngotracheal Stenosis Using Autologous Olfactory-mucosa-derived Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT05535803
- Acronym / sponsor ID
- IBCE_MSCStenosis
- Conditions
- Tracheal Stenosis, Laryngeal Stenosis
- Keywords
- mesenchymal stem cells, Tracheal/Laryngeal Stenosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
- Collaborators
- The Republican Center for Research and Practice in Otolaryngology
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with tracheal/laryngeal stenosis receiving standard treatment and stem cells | Experimental | Biological: Olfactory mucosa-derived mesenchymal stem cells, Other: Patients treated according to current clinical protocolsPatients with tracheal/laryngeal stenosis receiving standard surgical treatment and mesenchymal stem cells |
| Patients with tracheal/laryngeal stenosis receiving standard treatment | Active comparator | Other: Patients treated according to current clinical protocolsPatients with tracheal/laryngeal stenosis receiving standard surgical treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -confirmed diagnosis of chronic laryngeal or tracheal stenosis;
Key exclusion criteria (10 listed)
- refuse of patient to participate in the trial;
- acute infectious diseases;
- chronic mental disorders with severe manifestations;
- pregnancy/lactation;
- intercurrent severe chronic diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olfactory mucosa-derived mesenchymal stem cellsAutologous olfactory mucosa-derived mesenchymal stem cells | Biological | Patients with tracheal/laryngeal stenosis receiving standard treatment and stem cells |
| Patients treated according to current clinical protocolsPatients treated according to current clinical protocols | Other | Patients with tracheal/laryngeal stenosis receiving standard treatment, Patients with tracheal/laryngeal stenosis receiving standard treatment and stem cells |
Primary outcome
Number of patients who didn't require the repeated surgical interventions
Time frame: 1 year
Relative number of patients who didn't require the repeated surgical interventions after MSC therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Hancharou, Dr study director
Institute for biophysics and cellular engineering NAS of Belarus
Elvira Strinkevich, Dr study director
The Republican Center for Research and Practice in Otolaryngology
Valery Chekan, Dr study director
The Republican Center for Research and Practice in Otolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olfactory mucosa-derived mesenchymal stem cells and Patients treated according to current clinical protocols in people with Tracheal Stenosis and Laryngeal Stenosis, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who didn't require the repeated surgical interventions (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.