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Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

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ClinicalTrials.gov Identifier: NCT03130374
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : January 2, 2018
Sponsor:
Collaborators:
Belarusian Medical Academy of Post-Graduate Education
The Republican Center for Research and Practice in Otolaryngology
Information provided by (Responsible Party):
Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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

Condition or disease Intervention/treatment Phase
Tracheal Stenosis Laryngeal Stenosis Mesenchymal Stem Cells Biological: Olfactory mucosa-derived mesenchymal stem cells Phase 1 Phase 2

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Laryngotracheal Stenosis Using Autologous Olfactory-mucosa-derived Mesenchymal Stem Cells
Actual Study Start Date : January 3, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
Olfactory mucosa-derived mesenchymal stem cells
No Intervention: Control group
Patients treated according to current clinical protocols


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients who didn't require the repeated surgical interventions [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Tracheostomy decannulation [ Time Frame: 6 month ]
    Removal of the tracheostomy tube after the treatment.


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130374


Contacts
Contact: Andrei Y Hancharou, Dr +375296248972 andrei.hancharou@gmail.com
Contact: Natalia H Antonevich +375295987406 antonevich.n@gmail.com

Locations
Belarus
The Republican Center for Research and Practice in Otolaryngology Recruiting
Minsk, Belarus, 220000
Contact: Valery Chekan, Dr    +375297072360    lor3377@yandex.ru   
The Republican Research and Practical Center for Epidemiology and Microbiology Recruiting
Minsk, Belarus, 220114
Contact: Andrei Hancharou, Dr    +375296248972    andrei.hancharou@gmail.com   
Contact: Natalia H Antonevich    +375295987406    antonevich.n@gmail.com   
Sponsors and Collaborators
The Republican Research and Practical Center for Epidemiology and Microbiology
Belarusian Medical Academy of Post-Graduate Education
The Republican Center for Research and Practice in Otolaryngology
Investigators
Principal Investigator: Andrei Y Hancharou, Dr Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
Study Chair: Valery L Chekan, Dr Associate Professor of the Belarusian Medical Academy of Post-Graduate Education
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Article in Russian  This link exits the ClinicalTrials.gov site
Article in Russian  This link exits the ClinicalTrials.gov site
Abstract  This link exits the ClinicalTrials.gov site
Abstract  This link exits the ClinicalTrials.gov site
Abstract  This link exits the ClinicalTrials.gov site

Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Study Protocol  This link exits the ClinicalTrials.gov site
Responsible Party: Andrei Y. Hancharou, Head of the Laboratory for Immunology and Cellular Biotechnology,, The Republican Research and Practical Center for Epidemiology and Microbiology
ClinicalTrials.gov Identifier: NCT03130374     History of Changes
Other Study ID Numbers: RRPCEM_MSC1
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology:
mesenchymal stem cells
Tracheal Stenosis
Laryngeal Stenosis
cell therapy

Additional relevant MeSH terms:
Constriction, Pathologic
Tracheal Stenosis
Laryngostenosis
Pathological Conditions, Anatomical
Tracheal Diseases
 Respiratory Tract Diseases
Laryngeal Diseases
Otorhinolaryngologic Diseases
Respiratory System Abnormalities
Congenital Abnormalities