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CompletedNCT03130374Updated Jun 7, 2019

Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

A Phase 1/2 interventional study of Olfactory mucosa-derived mesenchymal stem cells in Tracheal Stenosis, Laryngeal Stenosis and Mesenchymal Stem Cells, sponsored by The Republican Research and Practical Center for Epidemiology and Microbiology. Completed at 2 sites in Belarus. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-06-07.

Sponsored by The Republican Research and Practical Center for Epidemiology and Microbiology · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
12
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.

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
  • Mesenchymal Stem Cells

Keywords

  • mesenchymal stem cells
  • Tracheal Stenosis
  • Laryngeal Stenosis
  • cell therapy
03

Who can participate

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

Inclusion criteria

  • confirmed diagnosis of chronic laryngeal or tracheal stenosis;
  • absence of cartilage damage.

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;
  • HIV, Hepatites B/C;
  • active tuberculosis;
  • alcohol use disorder/drug addiction;
  • cachexia of any origin;
  • malignant neoplasms.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Mesenchymal stem cell treated group

    Patients treated according to current clinical protocols plus autologous olfactory mucosa-derived mesenchymal stem cells

    Biological: Olfactory mucosa-derived mesenchymal stem cells

  • No intervention
    Control group

    Patients treated according to current clinical protocols

Interventions

  • BiologicalOlfactory mucosa-derived mesenchymal stem cells

    Olfactory mucosa-derived mesenchymal stem cells

05

What researchers measure

Primary outcomes

  1. Number of patients who didn't require the repeated surgical interventions

    Time frame: 1 year

Secondary outcomes

  1. Tracheostomy decannulation

    Removal of the tracheostomy tube after the treatment.

    Time frame: 6 month

06

Study locations

2 sites
  • The Republican Center for Research and Practice in Otolaryngology
    Minsk, 220000, Belarus
  • The Republican Research and Practical Center for Epidemiology and Microbiology
    Minsk, 220114, Belarus
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03130374
Lead sponsor
The Republican Research and Practical Center for Epidemiology and Microbiology
Collaborators
Belarusian Medical Academy of Post-Graduate Education, The Republican Center for Research and Practice in Otolaryngology
Responsible party
Andrei Y. Hancharou (Head of the Laboratory for Immunology and Cellular Biotechnology,, The Republican Research and Practical Center for Epidemiology and Microbiology) — Principal investigator
First posted
Apr 26, 2017
Start date
Jan 3, 2017
Primary completion
Jan 4, 2019
Completion
May 20, 2019
Last update
Jun 7, 2019

Study contacts

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

Oversight

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

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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