ClinicalTrials.gg
Status unknownNCT05535803Updated Sep 10, 2022

Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

A Phase 2 interventional study of Olfactory mucosa-derived mesenchymal stem cells and Patients treated according to current clinical protocols in Tracheal Stenosis and Laryngeal Stenosis, sponsored by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus. Status unknown at 1 site in Belarus. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-09-10.

Sponsored by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Enrolling by invitation — may be out of date.

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jun 2021, registered Aug 2022).
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Tracheal Stenosis
  • Laryngeal Stenosis

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Keywords

  • mesenchymal stem cells
  • Tracheal/Laryngeal Stenosis
03

In context

Tracheal Stenosis

42 studies on the registry are indexed under Tracheal Stenosis; 11 are open to participants now.

This study's planned enrollment of 20 is close to the median of 22 across 24 interventional studies indexed under Tracheal Stenosis.

Browse Tracheal Stenosis studies →

Lead sponsor

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus is the lead sponsor of 25 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-confirmed diagnosis of chronic laryngeal or tracheal stenosis;

Exclusion criteria

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;
  • , Hepatites B/C;
  • active tuberculosis;
  • alcohol use disorder/drug addiction;
  • cachexia of any origin;
  • malignant neoplasms.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Patients with tracheal/laryngeal stenosis receiving standard treatment and stem cells

    Patients with tracheal/laryngeal stenosis receiving standard surgical treatment and mesenchymal stem cells

    Biological: Olfactory mucosa-derived mesenchymal stem cells · Other: Patients treated according to current clinical protocols

  • Active comparator
    Patients with tracheal/laryngeal stenosis receiving standard treatment

    Patients with tracheal/laryngeal stenosis receiving standard surgical treatment

    Other: Patients treated according to current clinical protocols

Interventions

  • BiologicalOlfactory mucosa-derived mesenchymal stem cells

    Autologous olfactory mucosa-derived mesenchymal stem cells

  • OtherPatients treated according to current clinical protocols

    Patients treated according to current clinical protocols

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

07

Study locations

1 site
  • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
    Minsk, 220072, Belarus
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05535803
Lead sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
The Republican Center for Research and Practice in Otolaryngology
Responsible party
Sponsor
First posted
Sep 10, 2022
Start date
Jun 1, 2021
Primary completion
Jun 30, 2023 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Sep 10, 2022

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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