Tracheal StenosisPhase 1/2NCT03130374
Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells
A Phase 1/2 study testing Olfactory mucosa-derived mesenchymal stem cells in people with Tracheal Stenosis and Laryngeal Stenosis, run by The Republican Research and Practical Center for Epidemiology and Microbiology at 2 sites 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, Mesenchymal Stem Cells
- What is being tested?
- Olfactory mucosa-derived mesenchymal stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesBelarus
- Study dates
- 3 Jan 2017to 20 May 2019
- Phase
- Phase 1/2
- 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;
- absence of cartilage damage.
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
2 sites in 1 country.
Belarus2 sites
The Republican Center for Research and Practice in Otolaryngology
Minsk, 220000
The Republican Research and Practical Center for Epidemiology and Microbiology
Minsk, 220114
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.
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.
- Being tested
- Olfactory mucosa-derived mesenchymal stem cells
- Keywords
- mesenchymal stem cells, Tracheal Stenosis, Laryngeal Stenosis, cell therapy
- 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
Olfactory mucosa-derived mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cell treated group | Experimental | Patients treated according to current clinical protocols plus autologous olfactory mucosa-derived mesenchymal stem cells Receives: Biological: Olfactory mucosa-derived mesenchymal stem cells |
| Control group | No intervention | 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
Measured: 1 year
Secondary outcomes (1)
Tracheostomy decannulation
Removal of the tracheostomy tube after the treatment.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start3 Jan 2017
- Primary completion4 Jan 2019
- Study completion20 May 2019
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Republican Research and Practical Center for Epidemiology and Microbiology
- Sponsor type
- University, hospital or other
- Collaborators
- Belarusian Medical Academy of Post-Graduate Education, The Republican Center for Research and Practice in Otolaryngology
- Responsible party
- Principal investigator, Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology
- Investigators
- Andrei Y Hancharou, Dr, Principal investigator, Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and MicrobiologyValery L Chekan, Dr, Study chair, Associate Professor of the Belarusian Medical Academy of Post-Graduate Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130374
- Sponsor's protocol ID
- RRPCEM_MSC1
- Status last verified
- Jun 2019
- First submitted
- 12 Apr 2017
- Last updated
- 7 Jun 2019
- 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 7 Jun 2019. 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
- NCT03130374
- Acronym / sponsor ID
- RRPCEM_MSC1
- Keywords
- mesenchymal stem cells, Tracheal Stenosis, Laryngeal Stenosis, cell therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The Republican Research and Practical Center for Epidemiology and MicrobiologyUniversity, hospital or other
- Collaborators
- Belarusian Medical Academy of Post-Graduate Education, The Republican Center for Research and Practice in Otolaryngology
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 26 Apr 2017 (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.
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 |
|---|---|---|
| Mesenchymal stem cell treated group | Experimental | Biological: Olfactory mucosa-derived mesenchymal stem cellsPatients 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- confirmed diagnosis of chronic laryngeal or tracheal stenosis;
- absence of cartilage damage.
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 cellsOlfactory mucosa-derived mesenchymal stem cells | Biological | Mesenchymal stem cell treated group |
Primary outcome
Number of patients who didn't require the repeated surgical interventions
Time frame: 1 year
1 secondary outcome
Tracheostomy decannulation
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Article in RussianLink provided by the sponsor.
- Article in RussianLink provided by the sponsor.
- AbstractLink provided by the sponsor.
- AbstractLink provided by the sponsor.
- AbstractLink provided by the sponsor.
- 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 Y Hancharou, Dr 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 study chair
Associate Professor of the Belarusian Medical Academy of Post-Graduate Education
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Olfactory mucosa-derived mesenchymal stem cells in people with Tracheal Stenosis and Laryngeal Stenosis, run by The Republican Research and Practical Center for Epidemiology and Microbiology at 2 sites 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 2 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: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 7 Jun 2019.